[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neovascular-age-related-macular-degeneration-namd-wet-amd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neovascular-age-related-macular-degeneration-namd-wet-amd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652584","phase-2-phase-ii-study-of-subretinal-jwk001-for-neovascular-age-related-macular-degeneration-100652584",false,"NCT07776522","Phase II Study of Subretinal JWK001 for Neovascular Age-Related Macular Degeneration","A Phase II Study to Evaluate the Safety and Preliminary Efficacy of Subretinal Administration of JWK001 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Written informed consent and ability to comply with the study protocol.\n2. Male or female, aged 50-85 years.\n3. Active subfoveal MNV secondary to nAMD requiring anti-VEGF treatment.\n4. Demonstrated clinical response to aflibercept treatments in the study eye confirmed by the Reading Center;\n5. Study-eye BCVA of 19-78 ETDRS letters.\n6. Pseudophakic study eye.\n\nExclusion Criteria:\n\n1. Any ocular condition other than nAMD that may affect vision, study assessments, treatment safety, or interpretation of results.\n2. Intraocular surgery or intraocular corticosteroid treatment within 4 weeks at screening.\n3. Any ocular condition making the study eye unsuitable for subretinal injection.\n4. Active ocular infection or inflammation, or a history of idiopathic or autoimmune uveitis.\n5. Monocular status or non-study-eye BCVA \\\u003C19 ETDRS letters.\n6. Clinically significant systemic disease or infection, malignancy, prohibited concomitant treatment, prior gene therapy, or recent participation in another clinical trial.\n7. Any other condition considered by the investigator to make the subject unsuitable for participation.","ALL","50 Years","85 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase II, randomized, open-label, active-controlled study designed to evaluate the preliminary efficacy and safety of a single subretinal administration of JWK001 at different dose levels in patients with neovascular age-related macular degeneration.",[27],"Neovascular Age-Related Macular Degeneration (nAMD) Wet AMD","RECRUITING","2026-08-17",{"date":31,"type":32},"2026-08-20","ACTUAL",{"date":34,"type":21},"2026-08-31",{"date":36,"type":21},"2032-01-14",{"name":38,"class":39},"West China Hospital","OTHER",16,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"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":49,"type":21},15,[24],"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.",[27],[54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78],"macular degeneration","AMD","neovascular macular degeneration","gene therapy","contralateral","Ixoberogene soroparvovec","Ixo-vec","Aflibercept","Neovascular age-related macular degeneration","nAMD","wAMD","ADVM","ADVM-022","wet AMD","Wet Age-related Macular Degeneration","CNV","Neovascular AMD","AAV","AAV vector","AAV.7m8-aflibercept","AAV.7m8","Eye disease","Blindness","Adeno-associated viruses","ADVM-022-14","2026-08-04",{"date":81,"type":32},"2026-08-05",{"date":83,"type":32},"2026-06-02",{"date":85,"type":21},"2031-06",{"name":87,"class":88},"Adverum Biotechnologies, Inc.","INDUSTRY",12,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":4},"100648987","early-phase-1-biomarkers-effectiveness-and-safety-of-aflibercept-8mg-modified-fixed-dose-regimen-in-treatment-nave-namd-patients-100648987","NCT07728981","Biomarkers, Effectiveness, and Safety of Aflibercept 8mg Modified Fixed Dose Regimen in Treatment-Naïve nAMD Patients","A Prospective, Multicenter, Open-Label Phase IV Clinical Study to Evaluate the Biomarkers, Effectiveness, and Safety Based On A Modified Fixed Dose Regimen of Aflibercept 8mg in Treatment-Naïve Patients With Neovascular Age-Related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n1. Patients who fully understand the content, procedures, and possible adverse events (AEs) of this study and are able to provide written informed consent;\n2. Male or female patients aged ≥50 years at the time of signing the informed consent;\n3. Women of childbearing potential (WOCBP) must agree to use dual contraception during the study and for 4 months after discontinuation of study treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom). Women who have undergone surgical sterilization (such as hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or menopause for more than 1 year are considered not of childbearing potential. Women of childbearing potential must have a negative pregnancy test at screening and must not become pregnant, breastfeed, lactate, or plan pregnancy, breastfeeding, or egg donation during the study and for 4 months after discontinuation of study treatment;\n4. Male subjects whose partners are of childbearing potential must agree to use dual contraception during the study and for 4 months after the end of treatment, consisting of one medically recognized contraceptive method with a failure rate of less than 1% per year (see Appendix 1 for Contraceptive Measures, Definitions and Requirements for Women of Childbearing Potential) combined with a barrier method (e.g., condom), and must agree not to donate sperm during the study and for 4 months after the end of treatment.\n\n   Inclusion Criteria for Study Eye\n\n   Subjects included in this study must meet all of the following ocular inclusion criteria for the study eye:\n5. Have sufficiently clear ocular media and adequately dilated pupils to obtain high-quality retinal images for diagnosis;\n6. Untreated nAMD with active subfoveal choroidal neovascularization (CNV), with total CNV area accounting for more than 50% of the total lesion area.\n7. SD-OCT examination showed the presence of intraretinal fluid (IRF) and\u002For subretinal fluid (SRF) in the foveal center of the retina.\n8. During the screening and baseline periods, BCVA scores measured using the ETDRS visual acuity chart at an initial testing distance of 4 meters ranged from 78 to 24 ETDRS letters (inclusive) (approximately equivalent to Snellen visual acuity 20\u002F32 to 20\u002F320), and the vision loss was caused by nAMD.\n\nExclusion Criteria:\n\n1. Patients who have received other investigational treatments (including anti-VEGF, corticosteroids, laser photocoagulation treatments \\[panretinal photocoagulation or macular photocoagulation\\], and photodynamic therapy \\[PDT\\]) or approved nAMD drugs\u002Ftherapies;\n2. Patients with allergies or hypersensitivity reactions to any component\u002Fexcipient of the investigational product;\n3. Uncontrolled hypertension (defined as systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>95 mmHg). Subjects may be treated with up to three known antihypertensive drugs to achieve adequate blood pressure control. This restriction applies to drugs that can be used for treating hypertension, even if the primary purpose of taking the drug for the subject is not blood pressure control. Any medication known to affect blood pressure must have a stable regimen for 12 weeks prior to screening;\n4. History of other diseases, metabolic dysfunctions, abnormal physical examinations, or clinical laboratory abnormalities that reasonably suggest a contraindication to the investigational drug, may interfere with the interpretation of study results, or could place the patient at high risk for treatment-related complications;\n5. Any condition that, in the opinion of the investigator, may affect the patient's ability to provide informed consent, comply with the study protocol, complete the study according to study procedures, or for which the patient's participation may affect the study results or their own safety; Exclusion criteria for study eye\n6. Any eye with diabetic retinopathy (DR), diabetic macular edema (DME), or any retinal vascular disease other than nAMD;\n7. Presence of extraocular\u002Fperiocular infection or inflammation in any eye during the screening or baseline period;\n8. Presence of retinal pigment epithelium (RPE) tear or rupture, scarring, fibrosis, or atrophy involving the fovea;\n9. Fluorescein angiography (FA)\u002Ffundus photography (FP) showing:\n\n   1. Total lesion area (including hemorrhage, scarring, and neovascularization) greater than 12 disc areas (30.5 mm²);\n   2. Fibrosis or atrophy \\>50% of the total lesion area, and\u002For involving the fovea.\n10. Any intraocular disease that the investigator believes may reduce vision improvement or require medical or surgical intervention during the study (such as amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, epiretinal membrane with traction):\n\n    1. Presence of vitreous hemorrhage during the screening or baseline period;\n    2. Uncontrolled glaucoma (intraocular pressure still \\>25 mmHg despite anti-glaucoma medication);\n    3. Any cataract surgery or treatment for cataract surgery complications with steroids or yttrium-aluminum garnet (YAG) laser capsulotomy within 3 months prior to Day 1 of the study;\n    4. Any prior intraocular surgery (e.g., vitrectomy, glaucoma surgery, corneal transplantation, or radiation therapy);\n    5. Prior periocular or intravitreal drug injections (including anti-VEGF agents) for other retinal diseases;\n    6. Presence of intraocular inflammation\u002Finfection in any eye within 12 weeks prior to the screening visit;\n    7. History of idiopathic or autoimmune-related uveitis in the study eye.",{"count":98,"type":21},49,[100],"EARLY_PHASE1","Primary objective:\n\n• To evaluate the change in aqueous humor vascular endothelial growth factor A (VEGF-A) levels after 2 months of initial treatment with 8 mg Aflibercept in treatment-naïve nAMD patients.\n\nSecondary objectives:\n\n• To assess the efficacy, safety, and biomarker changes of 8 mg Aflibercept using a modified fixed-interval dosing regimen over 12 months in treatment-naïve nAMD patients.",[27],[104,105,106],"Neovascular Age-Related Macular Degeneration","Aflibercept 8mg","Modified Fixed Dose Regimen","NOT_YET_RECRUITING","2026-07-22",{"date":110,"type":32},"2026-07-27",{"date":112,"type":21},"2026-07-25",{"date":114,"type":21},"2027-12-31",{"name":116,"class":39},"Tianjin Medical University Eye Hospital"]