[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Adverum Biotechnologies, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"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":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100639045","phase-2-ixoberogene-soroparvovec-ixo-vec-contralateral-dosing-study-in-participants-with-neovascular-age-related-macular-degeneration-100639045","NCT07630649","Ixoberogene Soroparvovec (Ixo-vec) Contralateral Dosing Study in Participants With Neovascular Age-related Macular Degeneration","Evaluation of the Safety and Tolerability of Ixoberogene Soroparvovec (Ixo-vec) Intravitreal Gene Therapy in the Second (Contralateral) Eye of Participants With Bilateral Neovascular Age-related Macular Degeneration.","INCLUSION CRITERIA:\n\n1. Male or female, aged ≥ 50 years at Screening Visit 1.\n2. Must agree to use an acceptable form of contraception.\n3. Have diagnosis of bilateral CNV secondary to nAMD.\n4. Meet ETDRS BCVA letter score criteria:\n\n   * For Ixo-vec-experienced participants: Contralateral eye has an ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials.\n   * For Ixo-vec-naïve participants: Both the initial eye and contralateral eye have ETDRS BCVA letter score within a protocol-defined range appropriate for nAMD clinical trials\n5. Have prior treatment history consistent with protocol-defined requirements, including prior anti-VEGF therapy and, where applicable, prior Ixo-vec exposure.\n6. Demonstrate a meaningful anatomic response to anti-VEGF in the contralateral eye (all participants) and in the initial eye (Ixo-vec-naïve participants only). Meaningful anatomic response to prior anti-VEGF therapy as defined in the protocol.\n7. Able to comply with study procedures according to the Investigator's judgment.\n\nOther protocol-defined INCLUSION CRITERIA apply.\n\nEXCLUSION CRITERIA:\n\nA\u002F General Exclusion Criteria\n\n1. Have history of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant's ability to comply with the planned study assessments, 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 of 2019 (COVID-19) infection may meet this exclusion criterion if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.\n2. Received prior gene therapy (other than Ixo-vec, where applicable)\n3. Currently receiving steroids at Screening Visit 1 in the previously treated eye (Ixo-vec-experienced participants) or in either eye (Ixo-vec-naïve participants).\n4. Received any non-gene IMP or medical device in the contralateral eye (and\u002For initial eye for Ixo-vec-naïve participants) within 3 months of Screening Visit 1\n5. Have history of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administered as part of this study.\n6. Have evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0%\n7. Have history or evidence of cardiovascular diseases and ongoing bleeding disorders as defined by the protocol.\n8. Use of systemic immunosuppressive therapy within a protocol-defined period.\n9. Received systemic anti-VEGF therapy within a protocol-defined period.\n10. Have history of malignancy within the 5 years prior to Screening Visit 1, except for adequately treated malignancies as defined by the protocol.\n\n    B\u002FOcular Exclusion Criteria\n11. Have any active ocular or periocular infection in the contralateral eye in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only).\n12. Have any history or evidence of a concurrent intraocular condition in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), including retinal diseases other than nAMD, that, in the judgment of the Investigator, could reduce the potential for visual improvement, confound assessment of the macula or require medical or surgical intervention during the study.\n13. Have prior ocular surgery or treatment that may confound assessment or increase risk.\n14. Have any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip\u002Ftear in the contralateral eye (all participants) or in the initial eye (Ixo-vec-naïve participants only), as determined by the Investigator.\n15. Have uncontrolled ocular hypertension or glaucoma as defined by the protocol.\n16. Have any history of inflammatory anterior chamber cell or vitreous cell ≥ 2+ in the initial eye, that, in the opinion of the Investigator and Sponsor, predisposes the contralateral eye to a heightened risk of intraocular inflammation. Enrollment of a participant with prior anterior chamber cell or vitreous cell ≥2+ in the initial eye requires discussion with the medical monitor.\n\nOther protocol-defined EXCLUSION CRITERIA apply.",{"count":71,"type":21},15,[73],"PHASE2","The purpose of this study is to evaluate safety, effectiveness and durability of a gene therapy called Ixo-vec (Ixoberogene soroparvovec) when administered to the contralateral (second) eye of adult participants (≥ 50 years of age) who have been diagnosed with bilateral neovascular (wet) age related macular degeneration (nAMD). The study will enroll adults with nAMD in both eyes, including participants who previously received Ixo-vec treatment in one (initial) eye and\u002For participants who will receive Ixo-vec treatment for the first time. This study focuses on how the treatment works when both eyes are treated at different times and how effective and long-lasting Ixo-vec treatment is in the second (contralateral) eye.\n\nParticipants will receive a single administration of Ixo-vec in the contralateral eye and will be followed for approximately 5 years to evaluate safety, efficacy and durability of contralateral treatment. Secondary objectives include assessments that will evaluate clinical activity, including visual and anatomic outcomes, as well as the need for supplemental anti-VEGF therapy.\n\nThe study is intended to provide additional information on the safety, tolerability, and use of Ixo-vec in bilateral treatment.",[76],"Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD",[78,79,80,81,82,30,31,32,33,34,37,35,36,83,38,39,40,41,42,43,44,46,47,48,84],"macular degeneration","AMD","neovascular macular degeneration","gene therapy","contralateral","wet AMD","ADVM-022-14","2026-06-02",{"date":87,"type":54},"2026-06-05",{"date":85,"type":54},{"date":90,"type":21},"2031-06",{"name":60,"class":61},4,""]