[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"namd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:namd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,81,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100642316","phase-3-a-study-to-evaluate-efficacy-safety-and-immunogenicity-with-abp-938-8-mg-versus-eylea-hd-aflibercept-in-participants-with-neovascular-age-related-macular-degeneration-100642316",false,"NCT07614776","A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration","A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n* Men or women ≥ 50 years old, capable of giving signed informed consent\n* Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)\n* Total area of CNV (including both classic and occult components) \\> 50% of the total lesion area in the SE\n* The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE\n* Presence of intra and\u002For subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:\n\n* Total lesion size \\> 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye\n* Scar, fibrosis, or atrophy involving the central subfield in the study eye\n* Scar or fibrosis involving \\> 50% of the total lesion in the study eye\n* Presence of retinal pigment epithelium tears or rips involving the macula in the study eye\n* History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study\n* Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study\n* Uncontrolled glaucoma (defined as IOP \\>25 mmHg despite treatment with anti-glaucoma medication) in the study eye\n* History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye\n* Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization\n* Uncontrolled blood pressure (defined as systolic \\>160 mmHg or diastolic \\>95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening\n* Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF\u002Fanti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins\n* History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation\n* Other protocol-specified exclusion criteria","ALL","50 Years",{"count":19,"type":20},304,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)",[26,27],"Neovascular Age-related Macular Degeneration","nAMD",[29,30,31,32,33,34],"ABP 938","Aflibercept","neovascular age-related macular degeneration","Intravitreal","Randomized Controlled Trial","Double-masked","RECRUITING","2026-08-14",{"date":38,"type":39},"2026-08-17","ACTUAL",{"date":41,"type":39},"2026-05-27",{"date":43,"type":20},"2028-01-12",{"name":45,"class":46},"Amgen","INDUSTRY",51,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100651476","real-world-study-of-intravitreal-aflibercept-8-mg-in-pretreated-eyes-with-namd-or-dme-100651476","NCT07761039","Real-World Study of Intravitreal Aflibercept 8 mg in Pretreated Eyes With nAMD or DME","Multicentre Observational Study to Investigate the Interval-Extension Potential, Effectiveness and Safety of Intravitreal Aflibercept 8 mg in Pretreated Eyes With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Oedema (DME) Under Routine Clinical Practice in Portugal","ALLEVI8","Inclusion Criteria:\n\n-Inclusion criteria - nAMD cohort\n\n1. Diagnosis of neovascular age-related macular degeneration in the eye under treatment.\n2. Patient aged ≥50 years at the time of the first aflibercept 8 mg injection.\n3. The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.\n4. The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.\n5. Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.\n\n   Inclusion criteria - DME cohort\n6. Diagnosis of diabetic macular edema in the eye under treatment, in a patient with established type 1 or type 2 diabetes mellitus.\n7. Patient aged ≥18 years at the time of the first aflibercept 8 mg injection.\n8. The decision to initiate treatment with intravitreal aflibercept 8 mg, in accordance with the locally approved Summary of Product Characteristics, has been taken as part of routine clinical practice and independently of, and prior to, any decision to enroll the patient in the study.\n9. The eye under treatment has previously received at least three (3) intravitreal injections of an anti-angiogenic agent prior to the first administration of aflibercept 8 mg.\n10. Written informed consent has been provided by the patient (or legally acceptable representative) before the start of any study-related data collection, in accordance with applicable national and EU legislation.\n\n    Exclusion Criteria applicable to both cohorts:\n11. Concurrent participation in an interventional clinical investigation involving procedures outside routine clinical practice.\n12. Any contraindication listed in the locally approved Summary of Product Characteristics for intravitreal aflibercept 8 mg.\n13. Active extra-ocular or peri-ocular infection or active intraocular inflammation in either eye at the time of the first switch-related aflibercept 8 mg injection.\n14. Pre-existing ophthalmological condition in the eye under treatment (other than nAMD or DME) that, in the investigator's judgment, could materially affect the assessment of study outcomes - for example, advanced uncontrolled glaucoma, optic neuropathy or other retinal pathology.\n15. Concomitant use of any medicinal product whose interaction with intravitreal aflibercept 8 mg, as listed in the locally approved Summary of Product Characteristics, would compromise the assessment of treatment effect or patient safety.\n16. Prior intravitreal anti-VEGF treatment in the eye under treatment within the 28 days preceding the switch\u002Findex date.\n17. Prior intravitreal corticosteroid administration in the eye under treatment within the 3 months preceding the switch\u002Findex date.\n18. Fluocinolone acetonide intravitreal implant in the eye under treatment within the 3 years preceding the switch\u002Findex date.\n19. Dexamethasone intravitreal implant in the eye under treatment within the 6 months preceding the switch\u002Findex date.\n20. Any other concurrent drug-releasing intravitreal implant in the eye under treatment.\n21. Pregnancy at the time of the first switch-related aflibercept 8 mg injection.\n\n    Additional exclusion criterion - DME cohort only\n22. Macular laser photocoagulation in the eye under treatment within the 90 days preceding the first intravitreal aflibercept 8 mg injection.","18 Years",{"count":58,"type":20},100,"OBSERVATIONAL","The goal of this multicentre observational study is to evaluate the interval-extension potential, effectiveness, and safety of intravitreal aflibercept 8 mg in pretreated eyes with neovascular age-related macular degeneration (nAMD) or diabetic macular oedema (DME) under routine clinical practice in Portugal.\n\nIt consists in an ambidirectional longitudinal cohort with retrospective collection of pre-switch clinical and treatment history and prospective follow-up after initiation of intravitreal aflibercept 8 mg in routine clinical practice.\n\nThe main questions it aims to answer are:\n\n\\- Can treatment intervals be extended after switching to intravitreal aflibercept 8 mg while maintaining disease control in pretreated eyes with nAMD or DME? What are the functional, anatomical, and safety outcomes associated with intravitreal aflibercept 8 mg in routine clinical practice?\n\nParticipants are adults with nAMD or DME who have previously received intravitreal treatment and are switched to aflibercept 8 mg as part of routine clinical care. No study-specific interventions or procedures are performed. Clinical data are collected prospectively through the Portuguese national Retina.PT registry during routine follow-up visits, including treatment patterns, injection intervals, visual acuity, retinal anatomical assessments, and ocular and systemic safety outcomes.",[27,62],"DME",[64,65,66,67,68,69],"Neovascular age-related macular degeneration","Diabetic macular oedema","Aflibercept 8 mg","Interval extension","Real-world evidence","Treat-and-extend","NOT_YET_RECRUITING","2026-08-07",{"date":73,"type":39},"2026-08-12",{"date":75,"type":20},"2026-09-01",{"date":77,"type":20},"2027-12-31",{"name":79,"class":80},"Grupo de Estudos da Retina","OTHER",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100482508","phase-3-a-study-of-the-efficacy-safety-and-pharmacokinetics-pk-of-the-port-delivery-system-with-ranibizumab-pds-in-chinese-participants-with-neovascular-age-related-macular-degeneration-namd-100482508","NCT05562947","A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)","A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration","HUTONG","Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 9 months prior to the screening visit\n* Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard-of-care (SOC) within 6 months prior to the screening visit\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit\n* BCVA of 34 letters or better (20\u002F200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters\n* All subtypes of nAMD lesions are permissible\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment Study Eye\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD\n* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy\n* Previous treatment with corticosteroid IVT injection or corticosteroid implants\n* Previous intraocular device implantation (not including intraocular lens implants)\n* Previous laser (any type) used for age-related macular degeneration (AMD) treatment\n* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit\n* Prior treatment with IVT treatments for geographic atrophy\n* Concurrent conjunctival, Tenon's capsule, and\u002For scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant\n\nEither Eye\n\n* Prior treatment with brolucizumab\n* Prior gene therapy for nAMD or other ocular diseases\n* Previous participation in any ocular disease studies of investigational drugs and\u002For devices, within 3 months or five elimination half-lives of the investigational therapy, whichever is longer, preceding the screening visit\n\nB. Choroidal Neovascularization (CNV) Lesion Characteristics\n\nStudy Eye\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 millimeter square \\[mm\\^2\\]) in size at screening\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia\n\nC. Concurrent Ocular Conditions Study Eye\n\n* Retinal pigment epithelial tear\n* Any concurrent intraocular condition\n* Active intraocular inflammation (grade trace or above)\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the randomization visit\n* History of pars plana vitrectomy surgery\n* Aphakia or absence of the posterior capsule\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery\n* Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit\n* Uncontrolled ocular hypertension or glaucoma\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nFellow (Non-Study) Eye\n\n• Non-functioning fellow eye\n\nEither Eye\n\n* Any history of uveitis\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis",{"count":90,"type":20},68,[23],"This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg\u002FmL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in Chinese participants with nAMD.",[26,27],"2026-08-03",{"date":96,"type":39},"2026-08-04",{"date":98,"type":39},"2024-06-17",{"date":100,"type":20},"2029-08-30",{"name":102,"class":46},"Hoffmann-La Roche",16,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":129},"100567772","phase-1-multicenter-phase-iii-study-to-evaluate-the-safety-tolerability-pk-and-efficacy-of-sct520ff-in-patients-with-namd-100567772","NCT06672536","Multicenter, Phase I\u002FII Study to Evaluate the Safety, Tolerability, PK and Efficacy of SCT520FF in Patients With nAMD","A Multicenter, Dose-escalation and Dose-expansion, Phase I\u002FII Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy Characteristics of SCT520FF in Patients With Neovascular Age-related Macular Degeneration","Inclusion Criteria:\n\n1. Signed informed consent form.\n2. Age≥45 years, ≤80 years，male or femal.\n3. The study eye must meet the following criteria: Diagnosis of nAMD;Active MNV lesions secondary to nAMD; Total area of all types of lesions ≤12 optic disc areas; BCVA of the study eye 73\\~19 letters.\n\nExclusion Criteria:\n\n1. Macular-related retinal pigment epithelial tears in the study eye; scar, fibrosis, atrophy or dense subfoveal exudation involving the fovea in the study eye.\n2. Significant APD or opacity of the refractive medium and miosis in the study eye that affect visual acuity or fundus examination.\n3. Aphakia (except intraocular lens) or posterior capsular rupture of the lens in the study eye.\n4. The study eye has any eye diseases or medical history other than nAMD that may affect central vision and\u002For macular examine.\n5. MNV caused by non-nAMD exists in the study eye .\n6. Active inflammation or infection in either eye before randomization.\n7. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.\n8. Abnormal liver and kidney function.\n9. Poorly-controlled blood pressure before randomization.\n10. History of a cardiovascular and cerebrovascular events, including myocardial infarction, unstable angina pectoris, cerebrovascular accidents (including TIA), other thromboembolic diseases (such as thromboembolic angiitis, etc) within 6 months before randomization.\n11. Evidence of significant uncontrolled concomitant diseases.\n12. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) before randomization and have used the test drug or received device treatment.\n13. Pregnant, lactating women who can not take contraceptive measures during the trial.","45 Years","80 Years",{"count":114,"type":20},82,[116,117],"PHASE1","PHASE2","Multicenter, open-label, multi-dose study to evaluate the safety and tolerability in patients with nAMD treated with SCT520FF.",[27],"2025-08-27",{"date":122,"type":39},"2025-09-04",{"date":124,"type":39},"2024-11-26",{"date":126,"type":20},"2027-01-11",{"name":128,"class":46},"Sinocelltech Ltd.",1]