[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"namd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:namd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,71,120],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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",false,"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","ALL","50 Years",{"count":19,"type":20},304,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","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)",[26,27],"Neovascular Age-related Macular Degeneration","nAMD",[29,30,31,32,33,34],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","RECRUITING","2026-06-18",{"date":38,"type":39},"2026-06-22","ACTUAL",{"date":41,"type":39},"2026-05-27",{"date":43,"type":20},"2028-01-12",{"name":45,"class":46},"Amgen","INDUSTRY",20,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"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":57,"type":20},68,[23],"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.",[26,27],"2026-06-04",{"date":63,"type":39},"2026-06-08",{"date":65,"type":39},"2024-06-17",{"date":67,"type":20},"2029-08-30",{"name":69,"class":46},"Hoffmann-La Roche",16,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100470574","phase-3-pivotal-2-study-of-rgx-314-gene-therapy-in-participants-with-namd-100470574","NCT05407636","Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD","A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD","ASCENT","Inclusion Criteria:\n\n1. Age ≥ 50 years and ≤ 89 years\n2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye\n3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF\n4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye\n5. Willing and able to provide written, signed informed consent for this study\n6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry\n\nInclusion Criteria (Bilateral Treatment Substudy)\\*:\n\n1. An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes\n2. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes\n3. Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes\n4. Willing and able to provide written, signed informed consent for this study\n5. Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study\n\nExclusion Criteria:\n\n1. CNV or macular edema in the study eye secondary to any causes other than AMD\n2. Subfoveal fibrosis or atrophy in the study eye\n3. Any condition in the investigator's opinion that could limit VA improvement in the study eye\n4. Advanced glaucoma or history of secondary glaucoma in the study eye\n5. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months\n6. History of intraocular surgery in the study eye within 12 weeks prior to randomization\n7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6\n8. Prior treatment with gene therapy\n\nExclusion Criteria (Bilateral Treatment Substudy)\\*:\n\n1. CNV or macular edema in either eye secondary to any causes other than AMD\n2. Subfoveal fibrosis or atrophy in either eye\n3. Any condition in the investigator's opinion that could limit VA improvement in either eye\n4. Advanced glaucoma or history of secondary glaucoma in either eye\n5. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months\n6. History of intraocular surgery in either eye within 12 weeks prior to randomization\n7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6.\n8. Prior treatment with gene therapy (\\*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.\n\nNote: Other inclusion\u002Fexclusion criteria apply","89 Years",{"count":81,"type":20},714,[23],"ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.",[85,27,86,87,88,89],"AMD","Wet Age-related Macular Degeneration","wAMD","WetAMD","CNV",[91,92,93,94,95,96,97,98,99,30,100,101,102,103,104,105,106,107,108,85,109],"Age-Related Macular Degeneration","Neovascular Age-Related Macular Degeneration","Macular Degeneration","Wet Macular Degeneration","Choroidal Neovascularization","Retinal Degeneration","Retinal Diseases","Eye Diseases","Ranibizumab","Angiogenesis Inhibitors","Angiogenesis Modulating Agents","Growth Substances","Physiological Effects of Drugs","Growth Inhibitors","Antineoplastic Agents","Gene Therapy","Anti-vascular endothelial grown factory therapy","Anti-VEGF therapy","wet AMD","2026-04-15",{"date":112,"type":39},"2026-04-20",{"date":114,"type":39},"2022-01-13",{"date":116,"type":20},"2027-11",{"name":118,"class":46},"AbbVie",181,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":131,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100567772","phase-1-multicenter-phase-iii-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-sct520ff-in-patients-with-namd-100567772","NCT06672536","Multicenter, Phase I\u002FII Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD","A Multicenter, Dose-escalation and Dose-expansion, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age≥45 years, ≤80 years，male or femal.\n3. The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73\\~19 letters.\n\nExclusion Criteria:\n\n1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.\n2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.\n3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.\n4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and\u002For macular examine.\n5. MNV caused by non-nAMD exists in the study eye .\n6. Active inflammation or infection in either eye before randomization.\n7. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.\n8. Abnormal liver and kidney function.\n9. Poorly-controlled blood pressure before randomization.\n10. History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.\n11. Evidence of significant uncontrolled concomitant diseases.\n12. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.\n13. Pregnant, lactating women who can not take contraceptive measures during the trial.","45 Years","80 Years",{"count":130,"type":20},82,[132,133],"PHASE1","PHASE2","Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.",[27],"2025-08-27",{"date":138,"type":39},"2025-09-04",{"date":140,"type":39},"2024-11-26",{"date":142,"type":20},"2027-01-11",{"name":144,"class":46},"Sinocelltech Ltd.",1]