[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neovascular-age-related-macular-degeneration-namd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neovascular-age-related-macular-degeneration-namd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,89,115,152,174,208,231,257,280,313,341],{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632626","phase-3-study-to-evaluate-long-term-safety-of-intravitreal-otx-tki-axitinib-implant-in-participants-with-neovascular-age-related-macular-degeneration-who-successfully-completed-2-year-otx-tki-2023-amd-301-or-otx-tki-2023-amd-303-study-100632626",false,"NCT07516132","Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study","A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study","Inclusion Criteria:\n\n* Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96\n* Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging\n* Are able and willing to comply with all study requirements and visits\n* Have provided written informed consent\n\nExclusion Criteria:\n\n* Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1\n* History of intraocular inflammation in the study eye\n* Have evidence of a rhegmatogenous retinal detachment or visually significant\u002Fsevere epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular\n* Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results\n* Female participants who are pregnant (had a positive urine test at the Baseline visit \\[Day 1\\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.","ALL","50 Years",{"count":19,"type":20},850,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study",[26],"Neovascular Age-Related Macular Degeneration (nAMD)",[28,29,30],"Neovascular Age-Related Macular Degeneration","Tyrosine Kinase Inhibitor","OTX-TKI","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-04-27",{"date":39,"type":20},"2030-08-01",{"name":41,"class":42},"Ocular Therapeutix, Inc.","INDUSTRY",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100630015","phase-3-efficacy-and-safety-study-of-ixoberogene-soroparvovec-ixo-vec-in-participants-with-neovascular-age-related-macular-degeneration-aquarius-100630015","NCT07482176","Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)","A Multi-center, Randomized, Double-masked, Active-comparator-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)","AQUARIUS","Inclusion Criteria:\n\n1. Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits.\n2. Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity at Screening Visit 1.\n3. At least 50 years old at Screening Visit 1.\n4. An ETDRS BCVA letter score of 35 - 78 (approximate Snellen equivalent of 20\u002F200 to 20\u002F32) in the study eye at Screening Visit 1.\n5. Demonstrated a meaningful anatomic response to anti-VEGF therapy during screening.\n6. Able to reliably use eye drops per protocol.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria\n\n1. History of a medical condition giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study activities, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe coronavirus disease (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any important complications.\n2. Received any prior gene therapy.\n3. Prior treatment with any non-gene therapy investigational medicinal product (IMP) or medical device in the study eye within 3 months of Screening Visit 1 or 5 half-lives of the IMP prior to dosing with Ixo-vec, whichever is longer.\n4. Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future.\n5. History or evidence of any of the following cardiovascular diseases:\n\n   1. Myocardial infarction in the 6-month period prior to Week 1.\n   2. Uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg during screening.\n   3. Stroke in the 6-month period prior to Week 1.\n6. History of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted.\n7. Use of systemic immunosuppressive drugs within 90 days prior to Screening Visit 1. Short courses of oral corticosteroids are permitted, as well as any inhaled, intra-articular, nasal or dermal steroid use.\n8. Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% during screening.\n\nOcular Exclusion Criteria\n\n1. Any active ocular or periocular infection in the study eye from Screening Visit 1.\n2. History or evidence of the following in the study eye:\n\n   1. Intraocular or refractive surgery within 5 months prior to Week 1.\n   2. Any previous penetrating keratoplasty or vitrectomy.\n   3. Any previous panretinal photocoagulation.\n   4. Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age-related macular degeneration.\n3. Any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip\u002Ftear in the study eye, as determined by the Investigator during screening or at Week 1.\n4. Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1 to Week 1 or current use of ≥ 2 intraocular pressure (IOP) lowering medications or normal tension glaucoma\u002Fsuspect in the study eye or history of any of the following procedures in the study eye prior to Week 1:\n\n   1. Incisional glaucoma surgery (i.e., glaucoma drainage implant\u002Fshunt or trabeculectomy)\n   2. Ocular angle-based surgery (i.e., goniotomy or canaloplasty)\n   3. Minimally Invasive Glaucoma Surgery (MIGS) in the study eye.\n   4. Angle-based glaucoma surgery (e.g., Argon or Selective Laser Trabeculoplasty)\n5. Any history of IOP elevation related to topical steroid administration in either eye.\n6. Any history of uveitis or inflammation (grade trace or above) except mild anticipated post operative inflammation that resolved in either eye.\n7. Any history of treatment with complement inhibitors for geographic atrophy in the study eye.\n8. Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye.",{"count":53,"type":20},284,[23],"This is a multi-center, randomized, double-masked, active-comparator-controlled, Phase 3 study in a broad participant population (treatment-naïve and treatment-experienced) with neovascular (wet) age-related macular degeneration (nAMD). The study will evaluate a single intravitreal (IVT) injection of Ixo-vec compared to intravitreal aflibercept (active comparator). The primary endpoint of this study is the mean change in best corrected visual acuity (BCVA) of Ixo-vec compared to an active comparator measured as an average at Weeks 52 and 56.\n\nSafety, tolerability, and efficacy will be evaluated throughout the study.",[26,57],"Wet AMD",[59,60,61,62,63,64,65,57,66,67,68,69,70,71,72,73,74,75,76,77,78],"Ixoberogene soroparvovec","Ixo-vec","Aflibercept","Neovascular age-related macular degeneration","nAMD","ADVM","ADVM-022","wAMD","Wet Age-related Macular Degeneration","CNV","Neovascular AMD","AAV","AAV vector","AAV.7m8-aflibercept","AAV.7m8","Gene therapy","Eye disease","Blindness","Adeno-associated viruses","ADVM-022-13","2026-06-12",{"date":81,"type":35},"2026-06-15",{"date":83,"type":35},"2026-03-16",{"date":85,"type":20},"2031-10-20",{"name":87,"class":42},"Adverum Biotechnologies, Inc.",65,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"100642346","real-world-study-of-aflibercept-8-mg-in-namd-100642346","NCT07640997","Real-world Study of Aflibercept 8 mg in nAMD","REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.","Inclusion Criteria:\n\n* Patient aged ≥50 years\n* A diagnosis of nAMD\n* Signed informed patient consent before the start of data collection\n* Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of clinical routine practice\n* Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)\n* The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment\n* Intraocular pressure (IOP) in the study eye \\> 25 mmHg\n* Additional exclusion criteria for naïve nAMD patients:\n\n  * Any prior ocular treatment in the study eye or systemic treatment for nAMD\n* Additional exclusion criteria for pretreated nAMD patients:\n\n  * Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days\n  * Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months\n  * Dexamethasone implant in the study eye within the last 6 months\n  * Any concurrent drug releasing implant in the study eye",{"count":97,"type":20},300,"OBSERVATIONAL","The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:\n\nWhat are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?\n\nParticipants will:\n\nReceive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.\n\nProvide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).\n\nReport any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.",[26],[63,102,103],"Aflibercept 8mg","Real World Evidence","2026-06-10",{"date":106,"type":35},"2026-06-11",{"date":108,"type":35},"2025-11-11",{"date":110,"type":20},"2027-12-31",{"name":112,"class":113},"Peking University People's Hospital","OTHER",27,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100597920","phase-3-single-intravitreal-ivt-injection-of-4d-150-in-patients-with-macular-neovascularization-secondary-to-age-related-macular-degeneration-100597920","NCT07064759","Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration","A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration","4FRONT-2","Inclusion Criteria:\n\n* ≥50 years of age at time of consent\n* MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:\n\n  1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR\n  2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability\u002Fimprovement in response to previous IVT anti-VEGF treatment, as determined by the Investigator\n* Active subfoveal MNV or juxtafoveal\u002F extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center\n* Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center\n* BCVA between 25 and 78 ETDRS letters, inclusive (20\u002F320-20\u002F32 Snellen equivalent) in the study eye at the Screening Visit\n* CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center\n\nExclusion Criteria:\n\nOcular Conditions:\n\n* MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)\n* History of retinal detachment in the study eye\n* History of or presence of active inflammation in either eye\n* Glaucoma or intraocular hypertension requiring more than 2 topical medications for control\n\nOcular Treatments\u002FInterventions:\n\n* Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye\n\nSystemic Conditions and Considerations:\n\n* Major illness or major surgical procedure in the 28 days prior to the Screening Visit\n* Uncontrolled blood pressure\n* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit\n* History of autoimmune condition that may predispose to the development of uveitis",{"count":124,"type":20},480,[23],"A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration",[26],[129,130,131,69,132,62,133,134,57,135,63,136,137,138,139,140,141,121],"Age-related macular degeneration","AMD","Exudative AMD","Exudative age-related macular degeneration","Wet age-related macular degeneration","Wet macular degeneration","WAMD","Retinal gene therapy","Intravitreal gene therapy","Genetic Medicine","Ocular Gene Therapy","Gene Therapy","4FRONT","2026-04-14",{"date":144,"type":35},"2026-04-16",{"date":146,"type":35},"2025-07-22",{"date":148,"type":20},"2029-02",{"name":150,"class":42},"4D Molecular Therapeutics",94,{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100630585","phase-3-a-clinical-study-of-ql1207h-injection-versus-aflibercept-for-neovascular-age-related-macular-degeneration-100630585","NCT07489586","A Clinical Study of QL1207H Injection Versus Aflibercept for Neovascular Age-related Macular Degeneration","A Multicenter, Randomized, Double-Masked, Active-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of QL1207H Injection Versus Eylea® (Aflibercept, 114.3 mg\u002FmL, 8 mg Per 70 μL) in Patients With Neovascular Age-Related Macular Degeneration","Inclusion Criteria:\n\n1. At least 50 years of age.\n2. Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.\n3. Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.\n4. Presence of IRF and\u002For SRF affecting the central subfield of the study eye on OCT.\n5. BCVA ETDRS letter score of 78 to 24 in the study eye.\n\nExclusion Criteria:\n\n1. Causes of CNV other than nAMD in the study eye.\n2. Total lesion size \\>12 disc areas; or subretinal hemorrhage that is at least 50% of the total lesion area, or if the blood under the fovea is 1 or more disc areas in size in the study eye.\n3. Scar, fibrosis, or atrophy involving the central subfield in the study eye.\n4. Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n5. Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.",{"count":160,"type":20},356,[23],"The goal of this clinical trial is to evaluate the efficacy and safety of QL1207H injection versus aflibercept 8 mg in patients with neovascular age-related macular degeneration. The main question it aims to answer is:\n\n• Whether the efficacy and safety of QL1207H and aflibercept 8 mg are similar. Participants will receive injection once every 4 weeks for 3 consecutive doses, followed by injection once every 16 weeks at maximum.\n\nResearchers will compare QL1207H group and aflibercept 8 mg group to see if they are similar in improving best corrected visual acuity.",[26],"NOT_YET_RECRUITING","2026-03-18",{"date":167,"type":35},"2026-03-24",{"date":169,"type":20},"2026-03",{"date":171,"type":20},"2027-08",{"name":173,"class":42},"Qilu Pharmaceutical Co., Ltd.",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":182,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":187,"conditions":188,"keywords":192,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":206,"locationsCount":4},"100629963","speculum-free-intravitreal-injection-using-cotton-tipped-applicator-retraction-a-randomized-trial-of-pain-procedure-time-patient-satisfaction-and-safety-100629963","NCT07481500","Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Trial of Pain, Procedure Time, Patient Satisfaction, and Safety","Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: A Randomized Controlled Trial Comparing Pain Perception, Procedure Duration, Patient Satisfaction, and Safety Between Eyelid Speculum and Cotton-Tipped Applicator Retraction Techniques","IVI-RETRACT","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Diagnosed with neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO)\n3. Scheduled for intravitreal anti-VEGF injection (bevacizumab, aflibercept, or faricimab)\n4. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Active ocular infection or inflammation\n2. Known allergy to povidone-iodine, tetracaine, or levofloxacin\n3. Inability to cooperate with the injection procedure\n4. Concurrent participation in another interventional clinical trial\n5. Anatomical eyelid abnormality precluding use of either retraction technique","18 Years",{"count":184,"type":20},120,[186],"NA","This randomized controlled trial compares two techniques for eyelid retraction during intravitreal injection (IVI) of anti-VEGF agents: the standard wire eyelid speculum (Group A) versus cotton-tipped applicator retraction (Group B) in patients with neovascular AMD, diabetic macular edema, or retinal vein occlusion.\n\nThe study evaluates four outcomes: (1) patient pain perception measured by a 10-cm visual analogue scale immediately after injection; (2) procedure duration from retraction device placement to removal; (3) patient satisfaction assessed by a 5-item Likert scale; and (4) safety including rates of subconjunctival hemorrhage, corneal abrasion, endophthalmitis, and intraocular pressure elevation.\n\nA novel syringe cap technique using the Terumo 31G insulin syringe plastic cap as an injection-site marker (3.5 mm for pseudophakic eyes, 5.0 mm for phakic eyes from the limbus) is employed in both groups, replacing the traditional caliper.\n\nRandomization is stratified by diagnosis and prior injection history using permuted block randomization (block sizes 4 and 6). The target sample size is 120 patients (60 per group) at Walailak University Hospital, Nakhon Si Thammarat, Thailand.",[26,189,190,191],"Diabetic Macular Edema","Retinal Vein Occlusion","Intravitreal Injections",[193,194,195,196,197,198,199,200],"intravitreal injection","eyelid speculum","cotton-tipped applicator","injection pain","procedure time","patient satisfaction","anti-VEGF","randomized controlled trial","2026-03-13",{"date":165,"type":35},{"date":204,"type":20},"2026-06",{"date":171,"type":20},{"name":207,"class":113},"Jakkrit Juhong",{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":230},"100617385","phase-3-efficacy-and-safety-of-lx102-gene-therapy-in-patients-with-neovascular-age-related-macular-degeneration-namd-stellar-100617385","NCT07317934","Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)","A Phase III, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Subretinal Injection of LX102 in Participants With Neovascular Age-Related Macular Degeneration - The STELLAR Trial","Inclusion Criteria:\n\n1. Willing and able to provide written, signed informed consent for this study;\n2. Age ≥50 and ≤80 years old;\n3. active CNV secondary to nAMD in the study eye confirmed by FFA or OCT;\n4. The BCVA between 24 and 78 letters (inclusive) in the study eye at Screening;\n5. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;\n6. No anti-VEGF therapy in study eye within 28 days before screening;\n7. Must be pseudophakic in the study eye (at least 4 weeks after cataract surgery).\n\nExclusion Criteria:\n\n1. Any condition in the investigator's opinion that could limit VA improvement in the study eye.\n2. CNV or macular edema in the study eye secondary to any causes other than AMD\n3. Subfoveal fibrosis or atrophy in the study eye, as determined by CRC;\n4. History of retinal detachment in the study eye at any time;\n5. History of idiopathic or autoimmune uveitis in either eye;\n6. Advanced glaucoma in the study eye;\n7. History of vitrectomy surgery in the study eye;\n8. History of intraocular surgery within 1 month before screening in the study eye;\n9. History of ocular or systemic gene therapy;\n10. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.","80 Years",{"count":217,"type":20},332,[23],"This is a Phase III, randomized, open-label, active-controlled study to evaluate the efficacy and safety of subretinal injection of LX102 in participants with neovascular age-related macular degeneration. The study will evaluate a single subretinal injection of LX102 compared to an active comparator. The primary endpoint of this study is the mean change from D0 in BCVA based on an average at weeks 40 and 48.",[26,57],"2026-03-04",{"date":223,"type":35},"2026-03-05",{"date":225,"type":35},"2026-01-14",{"date":227,"type":20},"2032-06-04",{"name":229,"class":42},"Innostellar Biotherapeutics Co.,Ltd",31,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":215,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":242,"conditions":243,"keywords":244,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":251,"leadSponsor":253,"locationsCount":256},"100624192","phase-1-to-evaluate-the-safety-pharmacokinetics-and-efficacy-of-gb10-intravitreal-injection-in-patients-with-neovascular-age-related-macular-degeneration-namd-100624192","NCT07406438","To Evaluate the Safety, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","An Open-label, Multicenter, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of GB10 Intravitreal Injection in Patients With Neovascular Age-related Macular Degeneration (nAMD)","Key Inclusion Criteria:\n\n1. Diagnosed with choroidal neovascularization (CNV) secondary to AMD (nAMD); For the study eye, either no prior IVT anti-VEGF treatment (treatment-naïve patients) or the last injection of the prior IVT anti-VEGF treatment occurred \\> 3 months before the first dose, with investigator-assessed effectiveness of prior anti-VEGF therapy (previously treated patients).\n2. The study eye must have either subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity (as evidenced by subretinal fluid, subretinal hyper-reflective material, leakage, or hemorrhage);\n3. CNV lesion of all types (CNV lesion types in the study eye include predominantly classic, minimally classic, or occult \\[including polypoidal choroidal vasculopathy (PCV)\\]) with:\n\n   1. Total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas by FFA;\n   2. CNV component area of ≥ 50% of total lesion size by FFA;\n   3. Active CNV confirmed by FFA (evidence of leakage);\n   4. CNV exudation confirmed by SD-OCT (presence of fluid).\n4. BCVA letter score in the study eye of 78-24 letters (inclusive) in ETDRS-like charts (20\u002F32-20\u002F320 Snellen equivalent) before the first dose;\n5. Willingness to participate in the study, to comply with the study protocol, and to provide signed informed consent.\n\nKey Exclusion Criteria:\n\n1. CNV in the study eye due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis;\n2. The study eye on FFA:\n\n   1. Subretinal hemorrhage of \\> 50% of the total lesion area and\u002For that involves the fovea; or\n   2. Fibrosis or atrophy of \\> 50% of the total lesion area and\u002For that involves the fovea;\n3. Any concurrent intraocular condition in the study eye (e.g., central serous chorioretinopathy \\[CSC\\], retinal pigment epithelial tear involving the macula, amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction, retinal vein occlusion, etc.) that, in the opinion of the investigator, may either reduce the potential for visual improvement or require medical or surgical intervention;\n4. Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia in the study eye (for study eye with prior refractive surgery or cataract surgery, preoperative refractive error demonstrating more than 8 diopters), or axial length \\>26.5 mm when reliable refractive assessment is unavailable;\n5. Uncontrolled glaucoma (e.g., progressive loss of visual fields or defined as IOP≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye;\n6. Current or prior receipt of any treatment for the study eye, including but not limited to:\n\n   1. IVT implantation or injection other than anti-VEGF drugs within 6 months before screening (e.g., steroids, transplasminogen activator, ocriplasmin, C₃F₈ gas, air filling);\n   2. Periocular pharmacological interventions for retinal diseases within 6 months before screening (including subconjunctival, sub-tenon's, peribulbar, or retrobulbar injections);\n   3. Laser\u002Fphotodynamic therapies within 6 months before screening (including laser photocoagulation, verteporfin PDT, diode laser, or transpupillary thermotherapy);\n   4. Cataract surgery within 3 months before screening, or corticosteroid treatment for complications of cataract surgery, or YAG (yttrium aluminum garnet) laser posterior capsulotomy;\n   5. Prior other intraocular surgery (e.g., pars plana vitrectomy \\[PPV\\], glaucoma surgery \\[except YAG peripheral iridotomy \\>3 months prior\\], corneal transplant, or radiotherapy).\n7. Active intraocular inflammation (grade trace or above) in the study eye before the first dose;\n8. Current vitreous hemorrhage (grade trace or above) in the study eye before the first dose;\n9. Monocular vision or non-study eye BCVA \\\u003C 24 letters before the first dose;\n10. History of any cardiovascular\u002Fcerebrovascular events within 6 months before the first dose, including but not limited to: stroke (cerebrovascular accident), myocardial infarction, unstable angina, ventricular arrhythmias, and heart failure ≥ NYHA Class II;\n11. History of major surgery within 6 months before the first dose or plan to undergo surgery during the study;\n12. History of other disease, metabolic dysfunction, abnormal physical examination finding, or clinical laboratory finding prompting reasonable suspicion of a condition that might affect interpretation of the results of the study or render the patient at high risk for treatment complications in the opinion of the investigator, including but not limited to:\n\n    1. Hepatic\u002Frenal dysfunction (ALT\u002FAST\\>2.5×ULN; Cr\u002FBUN\\>2×ULN);\n    2. Uncontrolled diabetes (HbA1c≥7.5%);\n    3. Uncontrolled hypertension (resting SBP ≥160 mmHg and\u002For DBP ≥100 mmHg);\n    4. Platelets\\\u003C100×10⁹\u002FL; or coagulation dysfunction (PT\\>3 sec above ULN; APTT \\>10 sec above ULN);\n13. Pregnant or nursing (lactating) women;\n14. Any other conditions deemed by the investigator to render the participant unsuitable for trial participation.",{"count":239,"type":20},48,[241],"PHASE1","This study aims to preliminarily evaluate the efficacy and safety of GB10 intravitreal (IVT) injection for the treatment of patients with neovascular age-related macular degeneration (nAMD). It consists of two parts, single-ascending-dose escalation (SAD) and multiple-ascending-dose escalation (MAD).\n\nIn SAD, a single IVT of up to 6 doses will be administered to up to 36 treatment-naïve or previously treated patients with nAMD. If the lowest dose is considered safe without dose-limiting toxicity, escalation will proceed to the next higher dose level. At the end of SAD, the two doses that best balance efficacy and safety will be selected and entered into MAD.\n\nIn MAD, a single IVT of 2 doses will be administered to 12 treatment-naïve or previously treated patients with nAMD, who will be enrolled across the low- to high-dose levels.\n\nAfter GB10 intervention, the participants will undergo tests to evaluate the PK\u002FPD characteristics of GB10 and ocular and non-ocular safety.",[26],[63,245,246],"GB10","PK\u002FPD","2026-02-05",{"date":249,"type":35},"2026-02-12",{"date":249,"type":20},{"date":252,"type":20},"2027-06-30",{"name":254,"class":255},"Shenzhen Kexing Pharmaceutical Co., Ltd.","NETWORK",6,{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100552229","phase-3-a-phase-3-clinical-trial-to-compare-rbs-001-to-eylea-in-subjects-with-neovascular-age-related-macular-degeneration-100552229","NCT06470373","A Phase 3 Clinical Trial to Compare RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration","A Phase 3 Clinical Trial to Compare Efficacy, Safety, Tolerability and Immunogenicity of RBS-001 to Eylea® in Subjects With Neovascular Age-Related Macular Degeneration","Inclusion Criteria:\n\n1. Age ≥ 50 years at screening\n2. Individuals with active CNV lesion secondary to AMD in the study eye, proven by fluorescein angiography (FA) and confirmed by the central reading center during the screening period\n3. Individuals with CNV area in the study eye accounting for ≥ 50% of the total lesion, including macular hemorrhage, scar, atrophy, fibrosis and neovascularization, proven by FA and confirmed by the central reading center during the screening period\n4. Individuals with intraretinal or subretinal fluid in the study eye due to active CNV, proven by optical coherence tomography (OCT) and confirmed by the central reading center during the screening period\n5. Individuals with BCVA of 34 to 73 letters measured by ETDRS letter score at the screening and baseline visits in the study eye\n6. Individuals who voluntarily decide to participate in the clinical study after being fully informed of the details of the clinical study and who provide written consent to comply with the study instructions during the clinical study\n\nExclusion Criteria:\n\n1. Individuals whose study eye lesion meets any of the following criteria\n\n   * Total lesion\\* size - \\> 23 mm2 \\[9 disc areas (DAs)\\] (Must be proven by FA)\n   * Subretinal hemorrhage (or subfoveal hemorrhage) - ≥ 50% of the total lesion\\* \\[≥ 1 DA (In the case of subfoveal hemorrhage, fovea must be surrounded 270 degrees by visible CNV.)\\]\n   * Scar or fibrosis - ≥ 50% of the total lesion\\* or Scar, fibrosis, or atrophy involving the center of the fovea\n   * Retinal pigment epithelial tears or rips - Macular involvement\n   * Macular hole - At any stage, if present in the study eye\n   * Other causes of CNV - Ocular histoplasmosis syndrome, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, pathologic myopia (spherical equivalent of negative 8 diopters or more or axial length of 25 mm or more), etc.\n2. Individuals with any of the following concurrent diseases at screening or for a specified period of time\n\n   i. Concurrent ocular disease ii. Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg (despite adequate treatment) iii. Uncontrolled diabetes mellitus, at the investigator's discretion iv. Congestive heart failure with New York Heart Association (NYHA) functional classification 3 or 4 or any clinically significant heart disease including ventricular arrhythmia and atrial fibrillation, at the investigator's discretion v. Active systemic infection undergoing treatment or recurrent clinically significant infections within 4 weeks prior to the first dose of the IP\n3. Individuals with any medical history of the following at screening:\n\n   i. Other ophthalmic disease in the study eye that may affect safety\u002Fefficacy assessments in the subject or may require medical\u002Fsurgical interventions during the clinical study at the investigator's discretion (e.g., vitreomacular traction, glaucoma undergoing treatment, retinal detachment, corneal dystrophy, etc.) ii. Diabetic retinopathy (DR)\\*, diabetic macular edema (DME), retinal vein occlusion (RVO), uveitis, or other vascular disease affecting the retina (other than nAMD) in either eye \\*Mild non-proliferative DR will be permitted.\n\n   iii. Stroke, transient ischemic attack, pulmonary embolism, deep venous thrombosis or myocardial infarction within the past 24 weeks iv. Hypersensitivity reactions to aflibercept or other drugs to be used in the clinical study (fluorescein, mydriatic drops, etc.) v. Malignancy within the last 5 years (however, individuals with basal cell, cutaneous squamous cell carcinoma, in situ cervical cancer, or in situ breast ductal carcinoma who are in stable long-term follow-up without therapeutic medication, procedures, or surgery can participate in this clinical trial) vi. Organ or bone marrow transplantation\n4. Individuals with a history of any of the following medication or non-pharmacological treatment for the study eye i. Glaucoma filtering surgery, vitrectomy or corneal transplantation ii. Simple intraocular or periocular surgery (e.g., cataract surgery, simple neodymium yttrium aluminum garnet (Nd:YAG) laser capsulotomy on a pseudophakic eye due to posterior capsular opacification, etc.) within 12 weeks or eyelid surgery within 4 weeks prior to the screening visit \\[Laser iridotomy will be permitted.\\] iii. Macular photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiotherapy or retinal laser treatment (e.g., focal laser photocoagulation, pan-retinal photocoagulation, etc.) iv. Periocular radiotherapy v. Any anti-VEGF treatment for nAMD (including participation in other clinical studies) vi. Treatment for retinal detachment (medication or non-pharmacological treatment) vii. IVT corticosteroid injection, sub-tenon or periocular corticosteroid injection within 24 weeks or IVT corticosteroid implantation within 36 months prior to the screening visit\n5. Individuals with any of the following medication or non-pharmacological treatment history:\n\n   i. Systemic anti-VEGF therapy within 12 weeks prior to the first dose of the IP ii. Any anti-VEGF treatment of nAMD in the fellow eye within 8 weeks prior to the first dose of the IP iii. Current use at screening of medications known to be toxic to the lens, retina, or optic nerve, including deferoxamine, chloroquine\u002Fhydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol.\n\n   iv. Systemic corticosteroids administered within 12 weeks prior to the first dose of the IP (prednisolone ≤ 10 mg\u002Fday and equivalent dose administered for 14 days or less or inhaled\u002Fintranasal\u002Fdermal agents will be permitted.) v. Other IP within 12 weeks or 5 times the half-life (whichever is longer) prior to the first dose of the IP\n6. Individuals with BCVA of fewer than 34 letters measured by ETDRS letter score at the screening and baseline visits in the fellow eye\n7. Individuals who have only one functional eye (monocular vision)\n8. Pregnant \\[human chorionic gonadotropin (hCG) positive\\] or breastfeeding women of childbearing potential at the screening and baseline visits\n9. Men or women of childbearing potential who are unwilling to use adequate methods of contraception\\* from the time of written informed consent to 12 weeks after the last dose of the IP\n\n   \\* Adequate methods of contraception: Hormonal contraceptives (oral contraceptive pill, contraceptive patch, etc.), intrauterine device or intrauterine system implantation, sterilization procedure or surgery (vasectomy, bilateral tubal ligation, etc.), complete abstinence\n10. Individuals considered by the investigator to be ineligible for study participation for any reasons other than the inclusion and exclusion criteria",{"count":265,"type":20},434,[23],"This clinical study is designed to demonstrate the equivalence of the two Investigational Products by comparing the efficacy, safety, tolerability and immunogenicity of RBS-001 and Eylea® in subjects with Neovascular age-related macular degeneration.",[269],"Neovascular Age-related Macular Degeneration (nAMD)","2025-04-03",{"date":272,"type":35},"2025-04-06",{"date":274,"type":20},"2025-07",{"date":276,"type":20},"2026-09",{"name":278,"class":42},"Rophibio, Inc.",7,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":288,"sex":16,"minAge":182,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100578947","this-project-at-lmu-looks-at-how-using-ai-2nd-opinion-report-to-analyze-retinal-eye-scans-impact-doctors-decisions-about-treatment-for-patients-with-a-specific-eye-disease-namd-100578947","NCT06817915","This Project At LMU Looks At How Using AI 2nd Opinion Report to Analyze Retinal Eye Scans Impact Doctors' Decisions About Treatment for Patients with a Specific Eye Disease (nAMD)","LMU Project on the Impact of Reviewing AI Annotated SD-OCT Therapy Assistance Reports on Ophthalmologists' Treatment Decision-making for Anti-VEGF Therapy in NAMD Patients","LMU ASSIST","Inclusion Criteria:\n\n* Electronically consented to the informed consent form (eICF)\n* Criteria to be included in one of the following six Ophthalmology user groups:\n\nGroup 1 Non-retina specialist Group: Ophthalmology, completed ophthalmology residence with no or another subspecialty other than retina (e.g., Glaucoma, refractive, etc) Group 2 Resident Group: \\\u003C5 years in residency in ophthalmology Group 3 Fellow Group: Retina specialist in training Group: in fellowship in vitreoretinal medicine, medical retina Group 4 Retina specialist Group: completed retina training, regular requalification Group 5 Junior reader Group: have already gained experience in the reporting clinical routine with the diagnostics in question and completed the initial certification process at an Image and Reading Center (acc. to centre's SOP) Group 6 Senior reader Group: specialist with several years of experience in the relevant field or have completed at least 3 years of residency training. Completed the certification process at the Image and Reading Center (acc. to centre's SOP)\n\nExclusion Criteria:\n\n* Not an Ophthalmologist.\n* Does not have time to participate in the estimated project duration of 30 minutes.",true,{"count":290,"type":20},100,[186],"This is a research plan from the University of Munich (LMU) that aims to study how the use of AI reports can impact ophthalmologists' decisions regarding treatment for patients with neovascular age-related macular degeneration (nAMD). This disease is a leading cause of vision loss, and while anti-VEGF treatments are effective, they require careful monitoring and retreatment decisions to maximize benefits.\n\nThe study will involve up to 1000 ophthalmologists with varying levels of expertise. These ophthalmologists will review SD-OCT scans and make treatment decisions before and after reviewing AI-generated reports. The primary objective is to compare these decisions and see how the AI reports influence them. Secondary objectives include assessing the accuracy and safety of the AI reports.",[26],[295,296,297,298,299,300,301,63,199,302],"Decison-making","AI-Assisted treatment","artificial intelligence","clinical decision support","ophthalmology","SD-OCT","neovascular age-related macular degeneration","explainable AI","2025-02-07",{"date":305,"type":35},"2025-02-10",{"date":307,"type":20},"2025-01-30",{"date":309,"type":20},"2026-01-30",{"name":311,"class":113},"Johannes Schiefelbein",1,{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":327,"overallStatus":164,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":4},"100563985","phase-1-open-label-dose-escalation-study-for-crisprcas13--rna-targeting-therapy-for-the-treatment-of-neovascular-age-related-macular-degeneration-in-phase-i-trial-100563985","NCT06623279","Open-laBel Dose-escalation Study for CRISPR\u002Fcas13- Rna TargetInG THerapy for the Treatment of Neovascular Age-related Macular Degeneration in Phase I Trial","A Phase 1, Open-label, Multiple-cohort, Dose-escalation Study to Evaluate the Safety and Tolerability of HG202 High-fidelity CRISPR-Cas13 (hfCas13Y) RNA-targeting Therapy for Neovascular Age-related Macular Degeneration (nAMD)","BRIGHT","Inclusion Criteria:\n\n* Males or females ≥ 50 and ≤ 85 years at the time of signing the ICF;\n* Active macular choroidal neovascularization (MNV) secondary to nAMD in the study eye;\n* Sentinel (1st) subject for each dose cohort must have a BCVA ≤ 20\u002F63 and ≥ 20\u002F400 (≤63 and ≥ 19 ETDRS letters) in the study eye. Following the sentinel subject evaluation, the rest of the subjects in the dose cohort must have a BCVA between ≤ 20\u002F40 and ≥ 20\u002F400 (≤ 73 and ≥ 19 ETDRS letters) in the study eye.\n* Able to perform visual acuity and retinal function tests and able and willing to comply with study procedures for this clinical trial.\n\nExclusion Criteria:\n\n* Retinal or subretinal hemorrhage, scarring, or fibrosis of greater than 50% of the total lesion in the study eye;\n* Other ocular diseases that may affect central vision in the study eye;\n* Any other cause of CNV than nAMD in the study eye\n* Uncontrolled glaucoma in the study eye;\n* History or presence of corneal transplant or corneal dystrophy in the study eye;\n* History of other intraocular surgery in the study eye within 3 months prior to baseline;\n* Prior gene therapy or oligonucleotide therapy;\n* Other conditions judged by the investigator as inappropriate for the study.","85 Years",{"count":323,"type":20},15,[241],"Age-related macular degeneration (AMD) leads to severe and irreversible vision loss, while neovascular AMD (nAMD) accounts for 80-90% of AMD blindness. Current anti-VEGF therapies are the standard of care, but these therapies require life-long repeated intraocular injections. These frequent intravitreal injections increase the risk of complications, including submacular hemorrhage, intraocular hypertension, inflammation, and retinal detachment. Therefore, repeated treatments for nAMD place a substantial burden on healthcare systems, patients, and their caregivers. Additionally, approximately 25-35% of individuals with aggressive nAMD show suboptimal responses to the anti-VEGF therapies, experience treatment-extended failure, or require intensive, frequent intraocular injections, and do not prevent irreversible vision loss.\n\nHG202 is a CRISPR\u002FCas13 RNA-editing therapy delivered through one single AAV vector to partially knock down the expression of VEGFA and thus inhibit CNV formation in AMD. The long-term, stable delivery of HG202 following a one-time gene-editing therapy treatment for nAMD may potentially reduce the frequent injections and the potential risks of currently available anti-VEGF therapies since it does not rely on the long-term expression of anti-VEGF antibodies.",[26],[328,63,66,329,330,331],"Macular Degeneration","Gene-editing","CRISPR","HG202","2024-09-30",{"date":334,"type":35},"2024-10-02",{"date":336,"type":20},"2025-04-01",{"date":338,"type":20},"2031-02-01",{"name":340,"class":42},"HuidaGene Therapeutics Co., Ltd.",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":21,"phases":350,"briefSummary":352,"conditions":353,"keywords":354,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":365},"100553511","phase-2-trial-to-evaluate-the-safety-and-efficacy-of-eb-203-in-patients-with-neovascular-age-related-macular-degeneration-100553511","NCT06487039","Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration","A Randomization, Double-blind, Parallel, Multicenter-Phase 2a Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Adults aged 50 years or older\n2. Subjects with a best corrected visual acuity (BCVA) score between 25 and 73, measured by the Early Treatment of Diabetic Retinopathy Study(ETDRS) chart, at a distance of 4 m during the screening (equivalent to 20\u002F40 to 20\u002F320 in the Snellen chart)\n3. Subjects who voluntarily signed the informed consent form (ICF) after receiving the information on this study\n\nExclusion Criteria:\n\n1. Subjects with confirmed nAMD requiring standard treatment in both eyes (however, dry AMD in the non-study eye may be enrolled)\n2. Subjects who have received ocular or systemic treatment, such as photodynamic therapy (PDT) or laser photocoagulation, or have undergone a surgical operation for nAMD (however, health functional foods, vitamin supplements, etc., are excluded)\n3. Subjects whose study eye has been treated with anti-vascular endothelial growth factor (anti-VEGF) drugs (e.g. ranibizumab, bevacizumab, aflibercept, etc.) or a combination therapy for the treatment of nAMD prior to screening\n4. Subjects who have received intravitreal treatment using steroids\n5. Subjects who have a subretinal hemorrhage in ≥ 50% of the total lesion area or who have a hemorrhage in the subfoveal region of the study eye and in whom the hemorrhage area is ≥ 1 optic disk area\n6. Subjects with vitreous hemorrhage in the study eye\n7. Subjects who have undergone vitrectomy\n8. Subjects with a history of retinal detachment, congenital disease, or treatment and\u002For surgical history for retinal detachment\n9. Subjects with scarring, fibrosis, or atrophy involving the center of the fovea of the study eye\n10. Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)",{"count":349,"type":20},50,[351],"PHASE2","Trial to Evaluate the Safety and Efficacy of EB-203 in Patients with Neovascular Age-related Macular Degeneration.\n\nThe purpose of this study is to primarily investigate the safety and tolerability of EB-203 by dose in patients with neovascular Age-related Macular Degeneration (nAMD), and to secondarily evaluate the clinical efficacy. Subject to Adults aged 50 years or older and Neovascular age-related macular degeneration (nAMD)",[269],[63,355],"eye","2024-08-26",{"date":358,"type":35},"2024-08-27",{"date":360,"type":35},"2024-08-01",{"date":362,"type":20},"2026-01",{"name":364,"class":42},"EyebioKorea, Inc.",5]