[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neovascular-age-related-macular-degeneration-amd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neovascular-age-related-macular-degeneration-amd":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100621034","phase-4-a-prospective-multicenter-open-label-randomized-clinical-trial-to-evaluate-the-efficacy-durability-and-safety-of-aflibercept-8mg-in-different-treatment-regimens-in-chinese-patients-with-polypoidal-choroidal-vasculopathy-pcv-100621034",false,"NCT07365371","A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)","Inclusion Criteria:\n\n* Patients who fully understand the content, process, and possible AE of the study and capable of giving written informed consent form.\n* Male or female, age ≥ 50 years, at the time of signing the informed consent form.\n* Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom) during the study and for 4 months after discontinuation of study treatment. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or \\> 1 year postmenopausal. WOCBP must have negative results of pregnancy test at screening and must not be pregnant, breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and for 4 months after discontinuation of study treatment.\n* All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 4 months after participation in the study.\n* Ocular Inclusion Criteria for Study Eye: Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.\n* Ocular Inclusion Criteria for Study Eye: Confirmed diagnosis, by the investigator, of symptomatic macular PCV defined by the following: a. Active macular polypoidal lesions shown by ICGA, AND presence of CNV involving the macula area within the 6.0 mm ETDRS zone as identified by the investigator using multimodal images. b. BCVA scores of 78\\~24 ETDRS letters, inclusive (20\u002F32 to 20\u002F320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on study Day 1 Note: If both eyes meet the inclusion criteria, the eye with the worst visual acuity (VA) at the screening visit will be designated as the study eye. If both eyes have the same VA, the Investigator and patient will determine the study eye.\n\nExclusion Criteria:\n\n* Treatment with investigational therapy (anti-VEGF, corticosteroid, laser photocoagulation, panretinal or macular, and PDT) or approved medications for PCV treatment prior to initiation of study treatment on study Day 1.\n* Allergy or hypersensitivity to any of the compounds\u002Fexcipients in the study interventions formulations.\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Participants may be treated with up to 3 agents known to have anti-hypertensive effects for arterial hypertension to achieve adequate blood pressure control. This limit applies to drugs that could be used to treat hypertension even if their primary indication in the participant was not for blood pressure control. Any recent changes in medications known to affect blood pressure need to be stable for 12 weeks prior to screening.\n* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the participant at high risk for treatment complications.\n* Any other conditions that the Investigator considers may affect the patients' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the patients' participation in the test may affect the test results or their own safety.\n* Pregnant or breastfeeding.\n* Ocular Exclusion Criteria for Study Eye: Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF.\n* Ocular Exclusion Criteria for Study Eye: Retinal pigment epithelial tear involving the macula on study Day 1.\n* Ocular Exclusion Criteria for Study Eye: On FA\u002F fundus photograph (FP): a. Subretinal hemorrhage of \\>4 macular photocoagulation study disc area and\u002For that involves the fovea b. Fibrosis or atrophy of \\>50% of the total lesion area and\u002For that involves the fovea\n* Ocular Exclusion Criteria for Study Eye: Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, DR or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study a. Current vitreous hemorrhage on study Day 1 b. Uncontrolled glaucoma c. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months prior to study Day 1 d. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) e. Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases • Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye within 4 weeks of the screening visit f. Any intraocular inflammation\u002Finfection in either eye within 12 weeks of the screening visit g. History of idiopathic or autoimmune uveitis in the study eye.","ALL","50 Years",{"count":18,"type":19},174,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are:\n\n1. What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens?\n2. What proportion of patients achieve sustained disease control after receiving the loading dose?\n\nParticipants will:\n\n* Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses).\n* In Arm A:\n* Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48.\n* Return for an end-of-study visit at week 52.\n* In Arm B:\n* Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive.\n* Return for an end-of-study visit at week 52.\n\nThis study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.",[25,26],"Polypoidal Choroidal Vasculopathy (PCV)","Neovascular Age Related Macular Degeneration (AMD)",[25,28,29],"Neovascular age related macular degeneration (AMD)","Aflibercept 8mg","NOT_YET_RECRUITING","2026-01-22",{"date":33,"type":34},"2026-01-26","ACTUAL",{"date":36,"type":19},"2026-01-01",{"date":38,"type":19},"2027-12-31",{"name":40,"class":41},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine","OTHER",20,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100593352","progression-suppression-and-retinal-regression-in-vegf-resistant-amd-100593352","NCT07005323","Progression Suppression and Retinal Regression in VEGF-resistant AMD","Phase I\u002FIIa Clinical Study of PAL-222 Targeting Patients With Neovascular Age-related Macular Degeneration (AMD) That Shows no Response to Existing Therapy","PRESERVE","Inclusion Criteria:\n\n1. Patients aged between 50 and 85 years at the time of consent acquisition\n2. Patients diagnosed neovascular AMD in one or both eyes\n3. Patients with corrected letter vision in the subject eye of 20 letters or more (equivalent to decimal vision of 0.05) and less than 60 letters (equivalent to decimal vision of 0.32)\n4. Patients who apply to one or more of the followings:\n\n   ① RPE defect site in the RPE tear includes the Fovea\n\n   ② The Macular atrophy confirmed by low fundus autofluorescence extends to the fovea\n\n   ③ Patients with choroidal thinning (150 micrometer and less), subretinal fluid resistant to standard treatment, and high activity, but without hard exudated or subretinal hemorrhage which are indicators of the high risk of visual impairment.\n\n   ④ Patients with cystoid macular degeneration with photoreceptor cell loss and intraretinal fluid above fibrovascular pigment epithelial detachment, but without hard exudates or subretinal hemorrhage.\n5. Patients who had little improvement in exudative changes and no improvement, or deterioration of vision in recent two treatment with VEGF inhibitor therapy (two consecutive administration at 4-8-week intervals), after existing therapy\n\nExclusion Criteria:\n\n1. Patients with fibrovascular pigment epithelial detachment (thickness 50 µm or more) in the subfoveal area in the subject eye.\n2. Patients with hard exudates in the subretinal or intraretinal area in the subject eye.\n3. Patients with eye infections\n4. Patients with a history of retinal vascular disease other than neovascular AMD, retinal degenerative disease, rhegmatogenous retinal detachment, macular hole, premacular membrane with retinal wall, uveitis, or other ocular inflammatory disease in the subject eye.\n5. Patients with optic nerve atrophy in the subject eye\n6. Patients with progressive glaucoma in the subject eye (in whom intraocular pressure is not controlled, or visual field loss is progressive or has already spread to the macula)\n7. Patients with severe myopia in the subject eye (axial length of 26.5 mm or more, or spherical equivalent of -7.0 D or less in phakic eyes)\n8. Patients who have undergone intraocular surgery in the subject eye. (In the case of cataract surgery, patients may be enrolled if they have had no endophthalmitis or other complications, have progressed well, and more than 3 months have passed since the surgery)\n9. Patients with corrected visual acuity of the non-subject eye 0.1 or less\n10. Patients who are currently receiving or will receive VEGF inhibitor treatment in the non-subject eye during the study period\n11. Patients with abnormal findings that pose a problem in clinical trial participation in screening tests.\n12. Patients with positive HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody, syphilis serum reaction\n13. Patients with allergies to human serum albumin antibiotics, trypsin\n14. Patients with severe blood disorders, heart failure, liver disorders, and renal disorders\n15. Patients diagnosed with malignant tumor within 5 years or patients requiring treatment\n16. Pregnant women, lactating women, patients wishing to become pregnant during the trial period\n17. Patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial\n18. Patients with drug addiction or alcoholism","85 Years",{"count":53,"type":19},10,[55],"NA","The goal of this clinical trial is to assess safety and efficacy in patients with Neovascular Age-related Macular Degeneration with no response to existing therapy.\n\nThe main measures it aims to answer are:\n\n* Investigation of adverse events\n* Changes in clinical testing data\n* Changes in vital signs\n* Changes in intraocular pressure of the therapeutic eye\n* Changes in testing of anterior segment of the therapeutic eye Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy.\n\nResearchers will compare pre and post implantation of therapeutic eye to see if any safety issues recognized",[58],"Neovascular Age-related Macular Degeneration (AMD)","RECRUITING","2025-06-02",{"date":62,"type":34},"2025-06-05",{"date":64,"type":34},"2024-09-12",{"date":66,"type":19},"2027-03",{"name":68,"class":69},"PharmaBio Corporation","INDUSTRY",1]