[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wet-amd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wet-amd":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100630015","phase-3-efficacy-and-safety-study-of-ixoberogene-soroparvovec-ixo-vec-in-participants-with-neovascular-age-related-macular-degeneration-aquarius-100630015",false,"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.","ALL","50 Years",{"count":20,"type":21},284,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27,28],"Neovascular Age-Related Macular Degeneration (nAMD)","Wet AMD",[30,31,32,33,34,35,36,28,37,38,39,40,41,42,43,44,45,46,47,48,49],"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","RECRUITING","2026-06-12",{"date":53,"type":54},"2026-06-15","ACTUAL",{"date":56,"type":54},"2026-03-16",{"date":58,"type":21},"2031-10-20",{"name":60,"class":61},"Adverum Biotechnologies, Inc.","INDUSTRY",65,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"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":72,"type":21},332,[24],"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.",[27,28],"2026-03-04",{"date":78,"type":54},"2026-03-05",{"date":80,"type":54},"2026-01-14",{"date":82,"type":21},"2032-06-04",{"name":84,"class":61},"Innostellar Biotherapeutics Co.,Ltd",31]