[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neovascular-age-related-macular-degeneration\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neovascular-age-related-macular-degeneration":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,42,69,92,121,145,167,189,211,236,264,286,307,318,349,377,402,424,445,469],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053976","phase-1-a-safety-and-efficacy-study-of-one-time-sar402663-in-adults-with-neovascular-age-related-macular-degeneration-100053976",false,"NCT06660667","A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration","A Phase 1\u002F2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Between 50 and 90 years of age\n* Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20\u002F32 and 20\u002F400 and for expansion (Part II) between 20\u002F25 and 20\u002F200\n* Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye\n* Demonstrated a response to anti-VEGF treatment\n\nExclusion Criteria:\n\n* Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis in either eye\n* Current use of ocular corticosteroids in the study eye\n* Previous gene therapy\n* Any significant poorly controlled illness that would preclude study compliance and follow up\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","ALL","50 Years","90 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase 1\u002FPhase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration.\n\nParticipants will be enrolled in one of 2 parts:\n\n* In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants\n* In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose.\n\nAfter receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.",[28],"Neovascular Age-related Macular Degeneration","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2024-11-21",{"date":37,"type":21},"2031-06-30",{"name":39,"class":40},"Sanofi","INDUSTRY",18,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100593486","phase-3-study-to-assess-the-injection-burden-adverse-events-change-in-disease-activity-and-long-term-preservation-of-visual-acuity-of-surabgene-lomparvovec-in-adult-participants-with-neovascular-age-related-macular-degeneration-namd-100593486","NCT07007065","Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)","A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n* Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \\[Week -6\\]) in the study eye.\n* Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye\n\n  --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\\^2)\n* Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)\n\nExclusion Criteria:\n\n* CNV or macular edema in the study eye that is secondary to any causes other than AMD\n* Study eye with nAMD diagnosed \\> 4 years from Screening Visit 1\n* Any retinal pigment epithelial detachment \\> 400 μm or any pigment epithelial detachment \\> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.\n* Any subretinal hemorrhage in the study eye \\> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center\n* Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.",{"count":50,"type":21},561,[52],"PHASE3","Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).\n\nSurabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.\n\nParticipants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[28],[56,57,58],"Neovascular age-related macular degeneration","Surabgene Lomparvovec","ABBV-RGX-314","2026-06-25",{"date":61,"type":33},"2026-06-29",{"date":63,"type":33},"2025-11-05",{"date":65,"type":21},"2033-03",{"name":67,"class":40},"AbbVie",127,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100581225","phase-3-a-study-of-36-week-refill-exchanges-of-port-delivery-system-pds-with-ranibizumab-in-namd-100581225","NCT06847542","A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD","A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration","Sightspire","Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 24 months prior to screening\n* Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment\n\nStudy Eye:\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)\n* Previous treatment with corticosteroid intravitreal injection\n* Previous intraocular device implantation\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nEither Eye:\n\n* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study\n* Prior participation in a clinical trial involving any experimental therapies for nAMD\n* Prior treatment with brolucizumab or gene therapy for nAMD\n\nB. Macular Neovascularization\u002FChoroidal Neovascularization (MNV\u002FCNV) Lesion Characteristics:\n\nStudy Eye:\n\n* Subretinal hemorrhage that involves the center of the fovea\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye:\n\n* CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia\n* CNV masquerading lesions\n\nC. Concurrent Ocular Conditions:\n\nStudy Eye:\n\n* Subfoveal and\u002For juxtafoveal retinal pigment epithelial tear\n* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Active intraocular inflammation\n* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit\n* Aphakia or absence of the posterior capsule\n* Uncontrolled ocular hypertension or glaucoma\n* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis\n* Trichiasis\n* Corneal neuropathy\n* Lagophthalmos or incomplete blink\n* Active or history of facial nerve palsy\u002Fparesis\n\nFellow (Non-study) Eye:\n\n\\- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)\n\nEither Eye:\n\n* Any active or history of uveitis\n* Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis\n* Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis\n* Active or history of floppy eyelid syndrome\n* Active thyroid eye disease\n\nD. Concurrent Systemic Conditions:\n\n* Uncontrolled blood pressure\n* Active or history of autoimmune diseases\n* History of stroke within the last 3 months prior to informed consent\n* Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent\n* History of myocardial infarction (MI) within the last 3 months prior to informed consent\n* Confirmed active systemic infection\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer",{"count":78,"type":21},250,[52],"The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams\u002Fmilliliters (mg\u002FmL) refilled every 36 weeks (Q36W) in participants with nAMD.",[28],"2026-06-21",{"date":84,"type":33},"2026-06-24",{"date":86,"type":33},"2025-11-27",{"date":88,"type":21},"2028-11-15",{"name":90,"class":40},"Hoffmann-La Roche",59,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":5},"100642316","phase-3-a-study-to-evaluate-efficacy-safety-and-immunogenicity-with-abp-938-8-mg-versus-eylea-hd-aflibercept-in-participants-with-neovascular-age-related-macular-degeneration-100642316","NCT07614776","A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Men or women ≥ 50 years old, capable of giving signed informed consent\n* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)\n* Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE\n* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE\n* Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:\n\n* Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye\n* Scar or fibrosis involving \\> 50% of the total lesion in the study eye\n* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye\n* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study\n* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye\n* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye\n* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins\n* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation\n* Other protocol-specified exclusion criteria",{"count":100,"type":21},304,[52],"The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)",[28,104],"nAMD",[106,107,108,109,110,111],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","2026-06-18",{"date":114,"type":33},"2026-06-22",{"date":116,"type":33},"2026-05-27",{"date":118,"type":21},"2028-01-12",{"name":120,"class":40},"Amgen",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100427994","phase-4-a-study-assessing-corneal-endothelial-cells-in-participants-with-neovascular-age-related-macular-degeneration-namd-treated-with-the-port-delivery-system-with-ranibizumab-pds-100427994","NCT04853251","A Study Assessing Corneal Endothelial Cells in Participants With Neovascular Age-related Macular Degeneration (nAMD) Treated With the Port Delivery System With Ranibizumab (PDS)","A Phase IV, Multicenter, Open-label Study to Assess Corneal Endothelial Cells in Patients With Neovascular Age-related Macular Degeneration Treated With the Port Delivery System With Ranibizumab (PDS)","Belvedere","Inclusion Criteria\n\nOcular Inclusion Criteria:\n\n* Diagnosis of nAMD prior to screening as determined by the investigator\n* Difference of \\\u003C10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center\n* Availability of historical visual acuity (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion\n* Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening\n* Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:\n\n  * Overall decrease in nAMD disease activity detected on historical or screening OCT\n  * Stable or improved best-corrected visual acuity (BCVA)\n* BCVA of 34 letters (approximate 20\u002F200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment\n* All subtypes of nAMD lesions are permissible\n* nAMD lesions at the time of diagnosis must involve the macula\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images\n\nExclusion Criteria\n\nPrior Ocular Treatment\n\nStudy Eye:\n\n* Prior treatment with external-beam radiation therapy or transpupillary thermotherapy\n* Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening\n* Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment\n* History of corneal transplant\n* History of conjunctival surgery in the superotemporal quadrant\n* History of intraocular inflammation following anti-VEGF injection\n\nEither Eye:\n\n* Previous PDS implantation\n* Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment\n* Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)\n* Prior pars plana vitrectomy surgery\n* Previous intraocular device implantation, excluding intraocular lenses\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening\n* Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening\n* Contact lens wear in either eye within 2 months of screening\n* Any prior penetrating ocular trauma\n* Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening\n* History of corneal transplantation, including partial-thickness corneal grafts\n* Prior treatment with brolucizumab\n* Prior treatment with external-beam radiation therapy or brachytherapy\n* History of hypersensitivity to ranibizumab or any excipients of Susvimo\n\nMacular Neovascularization Lesion (MNV) Characteristics\n\nStudy Eye:\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area \\[1.27 square millimeters (mm\\^2)\\] in size\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye:\n\n* MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia\n* MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)\n\nCurrent or Historical Ocular Conditions\n\nStudy Eye:\n\n* Retinal pigment epithelial tear\n* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment\n* Current vitreous hemorrhage\n* Current or history of retinal detachment\n* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery\n* Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia\n* Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery\n* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study\n* Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)\n* Conjunctival pathologies in the superotemporal quadrant\n* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis\n* Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure\n* Trichiasis\n* Corneal neuropathy\n* Lagophthalmos or incomplete blink\n* Active or history of facial nerve palsy\u002Fparesis\n\nFellow (Non-Study) Eye:\n\n• Concurrent or history of PDS implantation\n\nEither Eye:\n\n* Aphakia or absence of the posterior capsule\n* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Corneal ECD ≤1500 cells\u002Fmm2 in either eye at screening as determined by the independent reading center\n* Fuchs endothelial corneal dystrophy Grade ≥ 2\n* Previous corneal endothelial cell damage, including from blunt or surgical trauma\n* Any ocular condition that precludes obtaining an analyzable specular microscopy image\n* Active or history of corneal edema\n* Active or history of corneal dystrophies\n* Active or history of iridocorneal endothelial syndrome\n* Active or history of pseudoexfoliation syndrome\n* Active or history of herpetic keratitis or kerato-uveitis\n* Any active or history of uveitis\n* Active intraocular inflammation\n* Active or history of keratitis, scleritis, or endophthalmitis\n* Active ocular or periocular infection\n* Active or history of Sjogren's syndrome or keratoconjunctivitis sicca\n* Active or history of floppy eyelid syndrome\n* Active or history of chronic eye rubbing\n* Active thyroid eye disease\n\nConcurrent Systemic Conditions:\n\n* History of uncontrolled blood pressure\n* Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegener's)\n* History of stroke within the last 3 months prior to screening\n* Uncontrolled atrial fibrillation within 3 months of screening\n* History of myocardial infarction within the last 3 months prior to screening\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications, in the opinion of the investigator\n* Current active systemic infection\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 and a stable prostate-specific antigen for \\> 12 months\n* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit\n* Requirement for continuous use of any medications or treatments indicated as prohibited therapy\n* Pregnant or breastfeeding, or intention to become pregnant during the study\n* Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test",{"count":130,"type":21},188,[132],"PHASE4","This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).",[28],"2026-06-10",{"date":137,"type":33},"2026-06-12",{"date":139,"type":33},"2021-12-14",{"date":141,"type":21},"2027-10-29",{"name":143,"class":40},"Genentech, Inc.",51,{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":91},"100568407","a-real-world-study-to-gain-clinical-insights-into-faricimab-fareal-study-100568407","NCT06680817","A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)","Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)","Inclusion Criteria:\n\n* Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye\n* Patients have received at least one faricimab treatment (the first dose) in the study eye\n* Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)\n\nExclusion Criteria:\n\n* Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date\n* Concomitant participation in any interventional clinical study\n* Active ocular inflammation and\u002For suspected\u002Factive ocular infection in either eye\n* Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)\n* Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)\n* Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)","18 Years",{"count":154,"type":21},850,"OBSERVATIONAL","The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.",[28,158],"Diabetic Macular Edema","2026-06-05",{"date":161,"type":33},"2026-06-09",{"date":163,"type":33},"2025-02-05",{"date":165,"type":21},"2028-06-30",{"name":90,"class":40},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100482508","phase-3-a-study-of-the-efficacy-safety-and-pharmacokinetics-pk-of-the-port-delivery-system-with-ranibizumab-pds-in-chinese-participants-with-neovascular-age-related-macular-degeneration-namd-100482508","NCT05562947","A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)","A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration","HUTONG","Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 9 months prior to the screening visit\n* Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit\n* BCVA of 34 letters or better (20\u002F200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters\n* All subtypes of nAMD lesions are permissible\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment Study Eye\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD\n* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy\n* Previous treatment with corticosteroid IVT injection or corticosteroid implants\n* Previous intraocular device implantation (not including intraocular lens implants)\n* Previous laser (any type) used for age-related macular degeneration (AMD) treatment\n* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit\n* Prior treatment with IVT treatments for geographic atrophy\n* Concurrent conjunctival, Tenon's capsule, and\u002For scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant\n\nEither Eye\n\n* Prior treatment with brolucizumab\n* Prior gene therapy for nAMD or other ocular diseases\n* Previous participation in any ocular disease studies of investigational drugs and\u002For devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit\n\nB. Choroidal Neovascularization (CNV) Lesion Characteristics\n\nStudy Eye\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square \\[mm\\^2\\]) in size at screening\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia\n\nC. Concurrent Ocular Conditions Study Eye\n\n* Retinal pigment epithelial tear\n* Any concurrent intraocular condition\n* Active intraocular inflammation (grade trace or above)\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit\n* History of pars plana vitrectomy surgery\n* Aphakia or absence of the posterior capsule\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery\n* Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit\n* Uncontrolled ocular hypertension or glaucoma\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nFellow (Non-Study) Eye\n\n• Non-functioning fellow eye\n\nEither Eye\n\n* Any history of uveitis\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis",{"count":176,"type":21},68,[52],"This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg\u002FmL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.",[28,104],"2026-06-04",{"date":182,"type":33},"2026-06-08",{"date":184,"type":33},"2024-06-17",{"date":186,"type":21},"2029-08-30",{"name":90,"class":40},16,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100338192","phase-3-extension-study-for-the-port-delivery-system-with-ranibizumab-portal-100338192","NCT03683251","Extension Study for the Port Delivery System With Ranibizumab (Portal)","A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)","Portal","Inclusion Criteria:\n\n* Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)\n* Ability and willingness to undertake all scheduled visits and assessments\n* For women of childbearing potential: agreement to remain abstinent or use contraceptive measures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab\n* History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications\n* History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications\n* Requirement for continuous use of any medications or treatments indicated in the \"Prohibited Therapy\"\n\nSub-study 1\n\nInclusion Criteria\n\n\\- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures\n\nParticipants must meet the following ocular criteria for the study eye for substudy entry:\n\n* Diagnosis of exudative nAMD within 2 years prior to the enrollment visit\n* Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit\n* Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:\n\nOverall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)\n\n* All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.\n\nExclusion Criteria Prior Ocular Treatments Study Eye\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD\n* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy\n* Previous treatment with corticosteroid ITV injection\n* Previous intraocular device implantation\n* Previous laser (any type) used for AMD treatment\n\nEither Eye\n\n* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit\n* Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab\n\nCNV Lesion Charateristics Study Eye\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye\n\n\\- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia\n\nConcurrent Ocular Conditions Study Eye\n\n* Retinal pigment epithelial tear\n* Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Active intraocular inflammation (grade trace or above)\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit\n* Aphakia or absence of the posterior capsule\n* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye\n* Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit\n* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n* History of prior vitrectomy surgery and absence of posterior capsule\n\nEither Eye\n\n* History of idiopathic or autoimmune-associated uveitis\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis\n\nConcurrent Systemic Conditions\n\n* Inability to comply with study schedule or procedures as described in the study protocol\n* Uncontrolled blood pressure\n* History of stroke within the last 3 months prior to informed consent\n* Uncontrolled atrial fibrillation within 3 months of informed consent\n* History of myocardial infarction within the last 3 months prior to informed consent\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator\n* Current systemic treatment for a confirmed active systemic infection\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment\n* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit\n* History of albinism\n* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab\n\nSub-study 2\n\nInclusion Criteria:\n\n* Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center\n\nExclusion Criteria (Cohort 1 only):\n\nConcurrent Ocular Conditions-Study Eye\n\n* Any ocular condition that may render the patient at high risk for surgical or treatment complications\n* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit\n* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit\n* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss\n* Concurrent conjunctival, Tenon's capsule, and\u002For scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant\n* Ongoing ocular complications that might affect participant safety\n\nConcurrent Ocular Conditions-Either Eye\n\n* Suspected or active ocular or periocular infection\n* Any history of uveitis\n* Active blepharitis\n\nConcurrent Systemic Conditions\n\n* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications\n* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer\n* Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.",{"count":198,"type":21},1000,[52],"This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg\u002FmL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.",[202],"Neovascular Age-Related Macular Degeneration","2026-06-02",{"date":180,"type":33},{"date":206,"type":33},"2018-09-20",{"date":208,"type":21},"2029-12-31",{"name":90,"class":40},165,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":22,"phases":220,"briefSummary":221,"conditions":222,"keywords":223,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":235},"100508715","phase-3-home-oct-guided-treatment-versus-treat-and-extend-for-the-management-of-neovascular-amd-100508715","NCT05904028","Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD","AO","Key Inclusion Criteria:\n\n* Age ≥ 50 years\n* Have the capacity to consent on his\u002Fher own behalf\n* Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site\n* Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)\n* Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20\u002F320 or better (Snellen))\n* Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration\n* ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye\n\nKey Exclusion Criteria for Study Eye:\n\n* Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF\u002Fanti-Ang2 agent, or any other AMD therapy)\n* Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF\u002Fanti-Ang2 agent or with macular laser for any indication\n* Treatment with intravitreal corticosteroids within the last 6 months\n* A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)\n* MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia",{"count":219,"type":21},600,[52],"Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.",[28],[224],"optical coherence tomography","2026-05-15",{"date":227,"type":33},"2026-05-18",{"date":229,"type":33},"2023-11-09",{"date":231,"type":21},"2027-07-30",{"name":233,"class":234},"Jaeb Center for Health Research","OTHER",65,{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100635018","phase-1-a-study-of-prl3-zumab-in-neovascular-age-related-macular-degeneration-namd-100635018","NCT07547228","A Study of PRL3-zumab in Neovascular Age-related Macular Degeneration (nAMD)","Phase I\u002FII Study to Assess Safety and Efficacy of PRL3-zumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Patients with Neovascular Age-related Macular Degeneration (nAMD).\n2. Willing to provide written informed consent for the study.\n3. Patients undergoing intravitreal treatment having failed at least two Standard-of care treatments and be receiving ongoing intravitreal treatment at intervals of ≤ 8 weeks including Ranibizumab, Aflibercept, or Faricimab.\n4. Participants receiving intravitreal treatment at screening must complete a wash-out period before enrolment. This wash-out period should be calculated based on five half-lives of the specific intravitreal treatment the participant is receiving.\n\n   Below is the washing out period for some standard of care treatments.\n   1. Ranibizumab (half-life: 9 days) requires a wash-out period of 45 days (7 weeks)\n   2. Aflibercept (half-life: 11 days) requires a wash-out period of 55 days (8 weeks)\n   3. Faricimab (half-life: 7.5 days) requires a wash-out period of 37.5 days (5 weeks)\n   4. Bevacizumab (half-life: 6 days) requires a wash-out period of 30 days (4weeks)\n5. Subfoveal CNV or juxtafoveal\u002Fextrafoveal CNV with a subfoveal component related to the CNV activity identified by FFA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyperreflective material, or leakage).\n6. BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20\u002F32 to 20\u002F320) in the study eye.\n7. Decrease in BCVA determined to be primarily the result of nAMD or DR\u002FDME in the study eye.\n8. Presence of pigment epithelium detachment (PED), intraretinal fluid (IRF) and\u002For subretinal fluid (SRF) affecting the central subfield of the study eye on OCT.\n9. Adequate organ (liver and renal) and hematological functions as evidenced by the laboratory results obtained within 7 days of treatment which are within the normal range for the study population, or with abnormalities deemed not clinically significant by the investigators.\n\nExclusion Criteria:\n\n1. Scar, fibrosis, atrophy, or retinal pigment epithelial tears involving the central fovea in the study eye.\n2. Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n3. History of idiopathic or autoimmune uveitis in the study eye.\n4. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.\n5. Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening\u002Frandomization.\n6. Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg).\n7. Patient is receiving systemic glucocorticoids (only if higher than 10mg or equivalent of prednisolone daily) or other immunosuppressive treatment for autoimmune disease or any other medical condition.",{"count":244,"type":21},15,[24,25],"Study Design This is a Single-center, Phase I\u002FII placebo-controlled study to assess the safety and efficacy of PRL3-zumab in patients with Neovascular Age-related Macular Degeneration (nAMD).\n\nPRL3-zumab will be administered intravenously in 2-week interval for 3 doses. Normal saline (0.9% Sodium Chloride w\u002Fv) will be used in placebo treatment. The study will consist of 3 arms.\n\nArm-1: PRL3-zumab 3mg\u002Fkg intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-2: PRL3-zumab 6mg\u002Fkg intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=6) Arm-3: Placebo (normal saline 0.9% sodium chloride w\u002Fv) intravenously will be administered in 2 week interval followed by 20 weeks of monitoring (n=3)\n\nInitial 3 arms will be conducted on patients who failed Standard-of-Care (SOC) therapy. Response assessment will be done at every 4 weeks from last dose of treatment till 24-week.\n\nRandomization:\n\nRandomization will be done in 2:2:1 manner on PRL3-zumab (Arm 1), 3mg\u002Fkg (n=6); PRL3-zumab (Arm 2), 6mg\u002Fkg (n=6); and placebo group (Arm 3) (n=3). Randomization can be achieved using random number table which will be prepared before the commencement of clinical trial.\n\nThe allocation of participants will be done by Investigator and will be concealed from the participants.\n\nBlinding:\n\nSingle blinding will be done for this trial in which all participants are unaware of their treatment assignment. No blinding will be done on Investigator.\n\nPrimary Endpoints:\n\n1. Safety:\n\n   • Adverse Events: Frequency and severity of adverse events throughout the primary outcome assessment period will be assessed by the Investigator for severity according to Common Terminology Criteria for Adverse Events (CTCAE) version 5 or later\n2. RP2D:\n\n   • This study will confirm Recommended Phase 2 DOse (RP2D) established from Phase I Clinical Trial in Cancer patients conducted in National University Hospital Singapore (MC\u002F03\u002F0616).\n3. Efficacy:\n\n   * Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. Change in BCVA letter gain of 0-4 will be considered as primary end point.\n   * Change From Baseline in Central Subfield Retinal Thickness (CST) measured by Optical Coherence Tomography (OCT).\n\n\\[Assessment Time Frame: 4 weekly through 24 weeks\\]\n\nSecondary endpoints:\n\n* Change in visual Acuity (Best Corrected Visual Acuity) of 5 or more letters.\n* Proportion of patients gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline over time\n* Proportion of patients avoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from baseline over time\n* Proportion of patients with absence of intraretinal fluid measured by OCT\n* Proportion of patients with absence of subretinal fluid measured by OCT \\[Assessment Time Frame: 4 weekly through 24 weeks\\]\n\nCriteria for additional Therapy:\n\nOnce the treatment is stopped after the third dose, patients from all groups are eligible for additional therapy as open-label treatment if there is recurrence of disease activity, as defined by presence of any of the following criteria:\n\n1. Decrease of ≥5 letters in BCVA compared with average BCVA value over the previous two scheduled visits, owing to nAMD disease activity (as determined by the investigator).\n2. Increase of \\>50 µm in OCT-measured CST compared with the average CST value over the previous two scheduled visits.\n3. Recurrence of intra-retinal or sub-retinal fluid (if resolved previously)\n4. New macular hemorrhage\n\nPatients in the placebo group will be given PRL3-zumab (6mg\u002Fkg) if they fulfil the criteria for additional therapy. Additional therapy will be continued in subsequent monitoring visit until the progression of disease, or end of the trial. If patients show clinical benefit from the treatment, additional doses could be given based on investigators' judgment.\n\nCriteria for progression of disease:\n\n1. BCVA decreases by 15 letters or more from best recorded BCVA because of nAMD disease activity.\n2. an increase in OCT central retinal thickness 150 µm or more from lowest recorded measurement after 2 consecutive additional therapy occurring 1 month apart.",[248],"Neovascular Age Related Macular Degeneration",[250,251,104,252,253],"PRL3","PRL3-zumab","Neovasclar Age Related Macular Degeneration","Wet AMD","2026-04-23",{"date":256,"type":33},"2026-04-29",{"date":258,"type":33},"2025-10-11",{"date":260,"type":21},"2027-07-07",{"name":262,"class":40},"Intra-IMMUSG Pte Ltd",1,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":263},"100597043","early-phase-1-safety-and-efficacy-evaluation-of-lx111-gene-therapy-in-namd-patients-100597043","NCT07053358","Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients","An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits.\n2. Age ≥ 50\n3. Diagnosis of active CNV secondary to neovascular AMD\n4. BCVA ETDRS letters between 5 and 63\n5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy\n6. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.\n\nExclusion Criteria:\n\n1. CNV or macular edema in the study eye secondary to diseases other than nAMD\n2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement\n3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months\n4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg\n5. Uncontrolled diabetes defined as HbA1c \\>8.0% within 28 days prior to screening",{"count":272,"type":21},10,[274],"EARLY_PHASE1","The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.",[28],"2026-03-09",{"date":279,"type":33},"2026-03-10",{"date":281,"type":33},"2025-07-02",{"date":283,"type":21},"2029-12-30",{"name":285,"class":234},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":263},"100614149","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-ibi302insubjects-with-namd-100614149","NCT07275840","A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD","An Open-label, Multicenter, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Intravitreal Injection of IBI302 in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Have signed an informed consent form before participating in the research.\n2. Male or female individuals aged 50 or above at the time of signing the informed consent form;\n3. Active CNV under the macular fovea secondary to nAMD or active CNV involving the macular fovea.\n4. At baseline, the BCVA of the study eye was within the range of 19 to 78 ETDRS letters (including both ends).\n\nExclusion Criteria:\n\n1. According to the investigator's judgment, concomitant ocular diseases\u002Fsystemic diseases of the study eyes at screening or baseline may lead to participants' non-response to the study treatment or confuse the interpretation of the study results;\n2. The study eye has uncontrollable glaucoma;\n3. There is an active intraocular or periocular infection or inflammation in either eye;\n4. The non-study eye has severe visual function disorders;\n5. Within 90 days before baseline, the study eye had received anti-VEGF treatment;\n6. Within 90 days before baseline, the study eye had received anti-complement treatment;\n7. At any time before baseline, the study eye had received IBI302 treatment;\n8. Uncontrollable hypertension;\n9. Glycated hemoglobin (HbA1c) \\> 10.0% within 28 days prior to screening;\n10. Other exclusion criteria set by protocol.",{"count":294,"type":21},800,[25],"This study is designed for Open-label, multi-center, single-arm Phase II trail to evaluate the efficacy and safety of intravitreal injection of IBI302 in nAMD patients.",[28],"2026-01-07",{"date":300,"type":33},"2026-01-08",{"date":302,"type":33},"2025-12-05",{"date":304,"type":21},"2026-08-30",{"name":306,"class":40},"Innovent Biologics Technology Limited (Shanghai R&D Center)",{"id":308,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":26,"conditions":311,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":316,"leadSponsor":317,"locationsCount":41},"100566860",{"count":20,"type":21},[24,25],[28],"2025-11-19",{"date":314,"type":33},"2025-11-21",{"date":35,"type":33},{"date":37,"type":21},{"name":39,"class":40},{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":22,"phases":327,"briefSummary":329,"conditions":330,"keywords":333,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":348},"100587524","impact-of-intravitreal-faricimab-on-renal-function-in-diabetic-patients-100587524","NCT06929507","Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients","The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus","Inclusion Criteria:\n\n* Patients with diabetes\n* Patients with DME or nAMD or macular edema secondary to retinal vein occlusion\n* Patients already receiving nephroprotective drugs\n\nExclusion Criteria:\n\n* Patients with end stage renal disease\n* Pregnancy\n* Patients with other retinal disorders\n* Previous renal transplantation Patients under hemodialysis",{"count":326,"type":21},60,[328],"NA","This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. It is known that previous anti-VEGF agents has systematic absorption and may cause deterioration in renal function of the patients. However, the effect of Faricimab on kidney function has not been investigated yet. Taking into account that Ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.",[331,332,248],"Renal Function Disorder","Diabetic Macular Edema (DME)",[334,335,336,337,338],"renal function","intravitreal injection of anti-VEGF","faricimab","diabetic macular edema","diabetes mellitus","2025-04-19",{"date":341,"type":33},"2025-04-24",{"date":343,"type":33},"2025-03-10",{"date":345,"type":21},"2027-03-10",{"name":347,"class":234},"University Hospital, Alexandroupolis",2,{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100438146","regulatory-post-marketing-surveillance-study-for-brolucizumab-100438146","NCT04985487","Regulatory Post-Marketing Surveillance Study for Brolucizumab","Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)","Inclusion Criteria:\n\n1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information\n2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)\n\nExclusion Criteria:\n\n1. Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.\n2. Patients participating in other investigational drug trial","100 Years",{"count":358,"type":21},3000,"This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.",[28],[104,362,363,364,365,366],"Neovascularized age related macular degeneration","Beovu","regulatory Post Marketing Study","Beovu Injection","Beovu Prefilled Syringe","2025-01-11",{"date":369,"type":33},"2025-01-14",{"date":371,"type":33},"2021-08-18",{"date":373,"type":21},"2026-06-14",{"name":375,"class":40},"Novartis Pharmaceuticals",28,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":22,"phases":385,"briefSummary":386,"conditions":387,"keywords":388,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100515081","phase-1-phase-iii-study-of-skg0106-intravitreal-injection-in-patients-with-neovascular-age-related-macular-degeneration-namd-100515081","NCT05986864","Phase I\u002FII Study of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Phase I\u002FII Study to Evaluate the Safety and Preliminary Efficacy of SKG0106 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Inclusion criteria:\n\n1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;\n2. Aged ≥ 50 years at screening;\n\n   Study Eye:\n3. Diagnosis of nAMD as determined by the PI;\n4. Active CNV lesions secondary to age-related macular degeneration (AMD);\n5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment.\n\nExclusion Criteria:\n\n1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;\n2. Retinal pigment epithelial tear in the study eye at screening;\n3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;\n4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;\n5. History of retinal detachment or active retinal detachment in the study eye;\n6. Any prior gene therapy.",{"count":176,"type":21},[24,25],"This is a phase 1\u002F2 clinical study to evaluate the safety, preliminary efficacy, immunogenicity, and pharmacokinetic (PK) characteristics of SKG0106 in subjects with nAMD. Based on results from the phase 1 dose escalation study, the phase 2 expansion study will be conducted.",[28],[389,390,391,104],"AMD","wet AMD","wAMD","2025-01-08",{"date":394,"type":33},"2025-01-09",{"date":396,"type":33},"2024-02-23",{"date":398,"type":21},"2026-01-30",{"name":400,"class":40},"Skyline Therapeutics (US) Inc.",9,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":423},"100532456","phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-skg0106-in-patients-with-neovascular-age-related-macular-degeneration-namd-100532456","NCT06213038","A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)","An Open-label, Dose-escalation Study to Evaluate the Safety, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Characteristics of SKG0106 Intraocular Solution After Single Intravitreal Injection in Chinese Patients With Neovascular (Wet) Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Voluntary and able to sign a dated ICF prior to any study-related procedures and able to complete the study as required by the protocol;\n2. Aged ≥ 50 years at screening;\n\n   Study Eye:\n3. Diagnosis of nAMD as determined by the PI;\n4. Active CNV lesions secondary to age-related macular degeneration (AMD);\n5. Subjects must have been responsive to anti-VEGF therapy as assessed by the PI prior to study treatment\n\nExclusion Criteria:\n\n1. Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye at baseline;\n2. Retinal pigment epithelial tear in the study eye at screening;\n3. Current vitreous hemorrhage in the study eye or history of vitreous hemorrhage within 4 weeks prior to baseline;\n4. Any condition that, in the opinion of the investigator, may limit visual acuity improvement in the study eye;\n5. History of retinal detachment or active retinal detachment in the study eye;\n6. Any prior gene therapy.",{"count":410,"type":21},12,[24],"This is a clinical study to evaluate the safety, preliminary efficacy, immunogenicity of SKG0106 in subjects with nAMD.",[28],[389,390,391,104],"2025-01-06",{"date":392,"type":33},{"date":418,"type":33},"2023-05-05",{"date":420,"type":21},"2025-05-30",{"name":422,"class":234},"Youxin Chen",3,{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":263},"100526954","phase-1-safety-and-efficacy-of-rrg001-gene-therapy-in-subjects-with-neovascular-age-related-macular-degeneration-namd-100526954","NCT06141460","Safety and Efficacy of RRG001 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)","A Phase I\u002FIIa, Dose-escalation and Dose-extension Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures.\n* Patinets ≥50 years old.\n* Clinically diagnosed with CNV secondary to nAMD.\n* BCVA of the study eye is ≥5 letters and ≤73 letters(Snellen 20\u002F800\\~20\u002F40), as well as that of the other eye ≥19 letters(Snellen 20\u002F400).\n* Responding to anti-VEGF\n\nExclusion Criteria:\n\n* Presence of any other eye diseases other than nAMD in study eye that would affect the treatment or confusing the interpretation of the study results , as judged by the investigator.\n* CNV or macular edema in the study eye secondary to any causes other than AMD.\n* Uncontrolled glaucoma.\n* Uncontrolled hypertension despite medication.\n* Pregnant or lactating women or individuals with reproductive potential who are unwilling to take effective contraception during the study period.",{"count":432,"type":21},48,[24,25],"A Phase I\u002FIIa, Dose-escalation and Dose-expansion Study to Evaluate the Safety and Efficacy of Single Subretinal Injection of RRG001 in Subjects With Neovascular Age-related Macular Degeneration",[28],"2024-11-12",{"date":438,"type":33},"2024-11-14",{"date":440,"type":33},"2023-12-12",{"date":442,"type":21},"2030-12-31",{"name":444,"class":40},"Shanghai Refreshgene Technology Co., Ltd.",{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":452,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":458,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":263},"100553959","phase-1-gene-therapyft-003-for-wet-amd-100553959","NCT06492863","Gene Therapy(FT-003) for Wet AMD","A Dose-escalation and Dose-expanded Phase I\u002FII Clinical Study to Evaluate the Safety, and Efficacy of FT-003 in Subjects With Wet AMD","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients 50-80 years old at the time of signing the ICF;\n* Clinically diagnosed with nAMD;\n* Presence of active CNV\n* The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;\n\nExclusion Criteria:\n\n* •Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.","80 Years",{"count":454,"type":21},78,[24,25],"The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with neovascular age-related Macular Degeneration (nAMD). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.",[28],[459,104],"FT-003","2024-07-01",{"date":462,"type":33},"2024-07-09",{"date":464,"type":33},"2023-08-15",{"date":466,"type":21},"2028-10-15",{"name":468,"class":40},"Frontera Therapeutics",{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":16,"minAge":476,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":4,"overallStatus":481,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":4},"100486234","phase-1-gene-therapy-for-wet-amd-100486234","NCT05611424","Gene Therapy for Wet AMD","An Open-label, Single-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Subjects that are willing and able to follow study procedures;\n* Female or male patients ≥45 years old at the time of signing the ICF;\n* Clinically diagnosed with nAMD;\n* Presence of active CNV\n* The best corrected visual acuity (BCVA) of the studied eye is ≤ 53 letters;\n\nExclusion Criteria:\n\n• Presence of any other intraocular diseases other than nAMD in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.","45 Years",{"count":41,"type":21},[24],"FT-003 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of FT-003 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.",[28],"NOT_YET_RECRUITING","2023-04-24",{"date":484,"type":33},"2023-04-26",{"date":486,"type":21},"2023-05-01",{"date":488,"type":21},"2027-12-30",{"name":468,"class":40}]