[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kim's Eye Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100607380","phase-4-long-term-efficacy-of-faricimab-using-a-treat-and-extend-regimen-for-type-3-macular-neovascularization-100607380",false,"NCT07187804","Long Term Efficacy of Faricimab Using a Treat and Extend Regimen for Type 3 Macular Neovascularization","Inclusion Criteria:\n\n\\[General\\]\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\n\\[Ocular\\]\n\n* BCVA that is equal or higher than 24 Early Treatment Diabetic Retinopathy Study letters on Screening Day\u002F Day 0.\n* Confirmed diagnosis, by the investigator, of symptomatic type 3 neovascularization based on sufficiently clear ocular media and adequate pupillary dilatation allowing acquisition of good quality retinal images for confirmation.\n* Treatment naive participants\n\nExclusion Criteria:\n\n\\[General\\]\n\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* 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\n\n\\[Ocular\\]\n\n* Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.\n* Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.\n\nAny ocular or periocular infection within the last 2 weeks prior to Screening in either eye.\n\n* Any history of uveitis in either eye.\n* Presence of definite chorioretional anastomosis\n* Subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded 270 degrees by visible macular neovascularization.)\n* Scar or fibrosis, making up \\> 50% of total lesion in the study eye.\n* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.\n* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.\n* History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.\n* Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.\n* Prior vitrectomy in the study eye\n* Any history of macular hole of stage 2 and above in the study eye.\n* Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.\n* Prior trabeculectomy or other filtration surgery in the study eye.\n* Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n* Active intraocular inflammation in either eye.\n* Active ocular or periocular infection in either eye.\n* Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttrium aluminum garnet \\[YAG\\] posterior capsulotomy) in the study eye.","ALL","50 Years",{"count":18,"type":19},30,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","Type 3 macular neovascularization (MNV) is a subtype of neovascular age-related macular degeneration accounting for 10-20% of cases, notable for high rates of bilateral involvement and risk of profound vision loss, particularly if undertreated. Early and proactive therapy is crucial to prevent progression and preserve vision.\n\nFaricimab offers potential advantages in this setting. Eyes with type 3 MNV often show thin choroid, reticular pseudodrusen, and high GA risk, reflecting compromised choroidal perfusion. While anti-vascular endothelial growth factor (VEGF) agents suppress neovascularization, prolonged VEGF blockade may impair choriocapillaris health. Ang-2 inhibition, by promoting Tie2 activation and vascular stability, may protect choriocapillaris and reduce widespread retinal edema and hemorrhages observed in type 3 MNV.\n\nFinally, while treat-and-extend is widely used in practice, existing trials (TENAYA, LUCERNE) applied broader extension intervals than typically used clinically. In type 3 MNV, where undertreatment carries severe consequences, a more stringent faricimab-based treat-and-extend regimen with 2-week interval adjustments warrants investigation.",[25,26,27],"Age-related Macular Degeneration (ARMD)","Choroidal Neovascularization","Anti-vascular Endothelial Growth Factor",[29,30,31,32,33],"Age-related macular degeneration","Type 3 macular neovascularization","Retinal angiomatous proliferation","Faricimab","Treat and extend","NOT_YET_RECRUITING","2025-09-19",{"date":37,"type":38},"2025-09-23","ACTUAL",{"date":37,"type":19},{"date":41,"type":19},"2028-09-22",{"name":43,"class":44},"Kim's Eye Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100568647","phase-4-switching-to-aflibercept-8mg-in-patients-showing-limited-response-to-previous-treatment-100568647","NCT06683950","Switching to Aflibercept 8mg in Patients Showing Limited Response to Previous Treatment","Efficacy of Switching to Aflibercept 8mg in Patients With Neovascular AMD Showing Limited Response to Faricimab or Aflibercept 2mg","Inclusion Criteria:\n\n* Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.\n* Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.\n* Signed informed consent\n* Patients aged 50 years or older\n* Patients diagnosed with neovascular AMD or PCV\n* Patients underwent faricimab or aflibercept 2mg injections with an inverval of 4 to 16 weeks\n* Patients who continued to show persistent subretinal fluid (SRF) or intraretinal fluid (IRF) despite receiving two consecutive faricimab or aflibercept 2mg injections at the same injection interval.\n* In cases where the central retinal thickness did not decrease by more than 50 μm during two consecutive treatments prior to inclusion in the study\n* ETDRS BCVA letter score ≥25 letters (approximately 20\u002F320 or better) in the study eye\n\nExclusion Criteria:\n\n* Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD except dietary supplements or vitamins.\n* Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.\n* Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the patient beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.\n* Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.\n* Any history of uveitis in either eye.\n* Presence of definite chorioretional anastomosis\n* Scar or fibrosis, making up \\> 50% of total lesion in the study eye.\n* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.\n* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.\n* History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye.\n* Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 76 week study period.\n* Prior vitrectomy in the study eye\n* Any history of macular hole of stage 2 and above in the study eye.\n* Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as its unlikely to interfere with the injection.\n* Prior trabeculectomy or other filtration surgery in the study eye.\n* Uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.\n* Active intraocular inflammation in either eye.\n* Active ocular or periocular infection in either eye.\n* Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet \\[YAG\\] posterior capsulotomy) in the study eye.\n* History of corneal transplant or corneal dystrophy in the study eye.",{"count":54,"type":19},40,[22],"The treatment landscape for neovascular AMD has evolved with various anti-VEGF agents since 2006. Ranibizumab initially led the way, but its limited efficacy in reducing retinal edema paved the way for aflibercept in 2011, which became globally popular for its effectiveness and safety. Yet, aflibercept did not fully meet all patients' needs. In 2019, brolucizumab showed promising anatomical results but had higher risks of inflammation, limiting its use. Faricimab, introduced in 2022, aimed for longer-lasting effects by targeting VEGF-A and angiopoietin 2. Though it required fewer injections, questions remain about its long-term efficacy compared to aflibercept.\n\nDespite recent advancements, no agent has established itself as the new standard since aflibercept's introduction, leaving significant unmet needs. Aflibercept 8mg, approved in 2023, has shown promise by matching long-term visual outcomes of aflibercept 2mg with fewer injections and comparable safety. This study examines the effects of switching to aflibercept 8mg for patients with a limited response to previous treatments, addressing the potential for aflibercept 8mg to meet current needs more effectively and providing timely data for its global rollout.",[25],[29,59,60,61,32,62],"Choroidal neovascularization","Aflibercept","Aflibercept 8mg","Refractory","RECRUITING","2024-11-09",{"date":66,"type":38},"2024-11-12",{"date":68,"type":38},"2024-10-21",{"date":70,"type":19},"2026-05-31",{"name":43,"class":44},""]