[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polypoidal-choroidal-vasculopathy-pcv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polypoidal-choroidal-vasculopathy-pcv":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100628423","phase-3-efficacy-and-durability-of-a-personalized-treat-and-extend-regimen-of-faricimab-for-treatment-naive-polypoidal-choroidal-vasculopathy-100628423",false,"NCT07461441","Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy","HANGANG","Inclusion Criteria:\n\nPotential participants are eligible to be included in the study only if all of the following criteria apply:\n\n\\[Ocular Conditions\\]\n\n* Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), FA and spectral domain optical coherence tomography (SD-OCT) AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT.\n* BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.\n* Greatest liner dimension (GLD) of the total lesion area (branching vascular network \\[BVN\\] + polypoidal lesion) \\\u003C 5400 μm (equivalent to 9 macular photocoagulation study \\[MPS\\] Disc Area) as delineated by ICGA.\n\n\\[Systemic Conditions\\]\n\n* Signed Informed Consent Form\n* Age ≥ 50 years at the time of signing Informed Consent Form\n* Participants who are able to comply with the study protocol, in the investigator's judgment\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)\n\nExclusion Criteria:\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n\\[Ocular Conditions\\] in the Study Eye\n\n* Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline.\n* Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.\n* Macular laser photocoagulation (focal\u002Fgrid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline.\n* Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1\n* Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period.\n* Presence of subfoveal geographic atrophy or extensive retinal pigment epithelial atrophy involving the central subfield that, in the opinion of the investigator, may limit visual potential.\n* Presence of subfoveal fibrosis or scarring involving the central subfield as identified on color fundus photography or OCT.\n* Presence of subretinal or sub-RPE hemorrhage involving ≥50% of the total lesion area, or any hemorrhage obscuring the fovea.\n* Any active intraocular or periocular infection or active intraocular inflammation (IOI) in study eye or fellow eye at Screening or Baseline.\n* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \\> 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline.\n* Any PCV masquerades like macular aneurysms, macular telangiectasia, etc. in study eye.\n\nAdd these EC fro both eyes\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 \\[Systemic Conditions\\]\n\n  * Systemic anti-VEGF therapy any time prior to Baseline.\n  * Any major illness or major surgical procedure within 1 month before screening\n  * Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \\\u003C 6 (Grade Group of 1) and a stable prostate-specific antigen for \\>12 months\n  * Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)\n  * Systemic treatment for suspected or active systemic infection on study Day 1\n  * Uncontrolled blood pressure, defined as systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg while the participant is at rest on study Day 1\n  * History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1\n  * History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator\n  * History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study\n  * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab","ALL","50 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy",[26,27],"Polypoidal Choroidal Vasculopathy (PCV)","Age Related Macular Degeneration",[26,29,30],"Faricimab","Age-related macular degeneration","RECRUITING","2026-03-05",{"date":34,"type":35},"2026-03-10","ACTUAL",{"date":37,"type":20},"2026-03-01",{"date":39,"type":20},"2028-11-30",{"name":41,"class":42},"Yeungnam University College of Medicine","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100622927","phase-3-prospective-trial-of-the-efficacy-and-safety-of-a-personalized-regimen-of-high-dose-aflibercept-8mg-on-treatment-naive-polypoidal-choroidal-vasculopathy-the-pallas-trial-100622927","NCT07389980","Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial","PALLAS","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male or female patients ≥ 19 years of age at screening\n3. Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT\n4. Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)\n\nExclusion Criteria:\n\n1. Ocular conditions\u002Fdisorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)\n2. A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders\n3. Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye\n4. Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)\n5. Uncontrolled glaucoma defined as intraocular pressure (IOP) \\> 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)\n6. Ocular treatments: any anti-VEGF drugs, intraocular or periocular steroids, macular laser photocoagulation or PDT, previous ocular surgery except cataract surgery (study eye)\n7. Stroke or myocardial infarction during the 6-month period prior to baseline\n8. Systemic anti-VEGF therapy at any time.","19 Years",{"count":19,"type":20},[23],"The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.",[56,26],"Polypoidal Choroidal Vasculopathy",[58,56,49,59],"PCV","Aflibercept 8 mg","2026-01-28",{"date":62,"type":35},"2026-02-05",{"date":64,"type":20},"2026-12-24",{"date":66,"type":20},"2028-12",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"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","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.",{"count":75,"type":20},174,[77],"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.",[26,80],"Neovascular Age Related Macular Degeneration (AMD)",[26,82,83],"Neovascular age related macular degeneration (AMD)","Aflibercept 8mg","NOT_YET_RECRUITING","2026-01-22",{"date":87,"type":35},"2026-01-26",{"date":89,"type":20},"2026-01-01",{"date":91,"type":20},"2027-12-31",{"name":93,"class":42},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",20]