{"type":"trials","record":{"id":41567,"source_id":"clinicaltrials-gov","external_id":"NCT07520318","title":"This is a 96-week, Multicenter Study in Patients With Neovascular AMD That Evaluates OCUL101 for Efficacy, Safety, Durability, and Pharmacokinetics, Comparing it With Another Treatment. The Study Will be Conducted in Two Parts, Part A and Part B.","brief_summary":"Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or others. A comparator drug, Eylea® (aflibercept), will also be used in this study. Aflibercept is approved by regulatory agencies to treat neovascular AMD. VEGF-A (vascular endothelial growth factor A) is a protein released by the body in response to certain conditions that encourages the eye to form new blood vessels that are weak and leaky. This can lead to leakage of fluid and swelling in the macula; the part of the eye that helps you see clearly. C5 (component 5) is a part of the immune system released when there is ongoing damage to the eye such as when you have neovascular AMD. When it becomes too active in the eye, it can cause inflammation and further damage, leading to thinning of the back of the eye, a condition called geographic atrophy (GA). OCUL101 works by blocking both VEGF-A and C5. The main purpose of this study is to see how safe and tolerable OCUL101 is and how well OCUL101 works in participants when compared with aflibercept. From here on, OCUL101 and aflibercept will be referred to as the \"study drug.\" This study is divided into 2 periods: a screening period and a study treatment period. During each study period, you will have 1 or more visits with your study doctor at the center. The screening visit will last about 3 hours, and all other visits will last about 3 to 6 hours. This study has 2 Parts. Part A uses the 10.4 mg dose of OCUL101 and Part B uses 2 doses of OCUL101 (6.5 mg and 10.4 mg) to compare with 2 mg of aflibercept. Before any study-related tests and procedures can be done, you will be asked to read and sign this informed consent form, and then the study will begin with a screening visit. The purpose of the screening visit is to decide whether or not you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you. If the study doctor decides that you meet all of the requirements to be in this study, you will be assigned to either Part A or randomly assigned (like drawing straws) to one of the groups in Part B. You will then receive one of the following study treatment plans: * Part A, 10.4 mg of OCUL101 * Part B, Group 1, 6.5 mg of OCUL101 + as needed study treatments of 10.4 mg OCUL101 * Part B, Group 2, 10.4 mg of OCUL101 * Part B, Group 3, 10.4 mg of OCUL101 * Part B, Group 4, 2 mg of aflibercept You will receive 3 injections between Day 1 and Week 8, after which you may or may not receive additional injections every 8 weeks until Week 36. After you receive the set number of injections for your Part/group, you may receive additional injections during the study if the stud…","overall_status":"Not Yet Recruiting","phases":["PHASE2","PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Shenzhen Oculgen Biomedical Technology Co., Ltd.","enrollment":255,"countries":[],"start_date":"2026-04-17","completion_date":"2029-03-29","last_update_date":"2026-04-13","source_url":"https://clinicaltrials.gov/study/NCT07520318","editorial_summary":"A registered PHASE2, PHASE3 study indexed because it matched monitored longevity research terms. Registry status: Not Yet Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:30.378222+00:00","last_seen_at":"2026-09-25T06:20:47.789+00:00","metadata":{"sex":"ALL","acronym":"STAT","age_range":"50 Years to 89 Years","comparator":"Part A: Arm 1; Part B: Arm 1; Part B: Arm 2; Part B: Arm 3; Part B: Arm 4","organization":"Shenzhen Oculgen Biomedical Technology Co., Ltd.","interventions":["bispecific anti-VEGF and anti-complement"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). — From enrollment to the end of trea…","Part B: Change from baseline in mean BCVA score. — From enrollment followed by injection and assessments visits every 8…","Part A: Change in baseline in mean BCVA score. — From enrollment until week 16","Part A: Change from Baseline in mean central subfield macular thickness (CST). — From enrollment to end of treatment at…","Part B: Mean change from baseline in CST. — From enrollment to Week 36.","Part B: Proportion of participants with greater than or equal to 15-letter improvement in BCVA from baseline. — From en…","Part B: Percent change in CNV lesion size vs aflibercept. — From enrollment to Week 96.","Part B: Change in square root of GA lesion size. — From enrollment to Week 96."],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Adults With Neovascular Age-related Macular Degeneration","bispecific anti-VEGF and anti-complement"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":100,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct07520318","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2026-04-17 to 2029-03-29","comparator":"Part A: Arm 1; Part B: Arm 1; Part B: Arm 2; Part B: Arm 3; Part B: Arm 4","confidence":"structured-source","population":"ALL · 50 Years to 89 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:20:47.835Z","intervention":["bispecific anti-VEGF and anti-complement"],"participants":255,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2, PHASE3","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). — From enrollment to the end of trea…","Part B: Change from baseline in mean BCVA score. — From enrollment followed by injection and assessments visits every 8…","Part A: Change in baseline in mean BCVA score. — From enrollment until week 16","Part A: Change from Baseline in mean central subfield macular thickness (CST). — From enrollment to end of treatment at…","Part B: Mean change from baseline in CST. — From enrollment to Week 36.","Part B: Proportion of participants with greater than or equal to 15-letter improvement in BCVA from baseline. — From en…","Part B: Percent change in CNV lesion size vs aflibercept. — From enrollment to Week 96.","Part B: Change in square root of GA lesion size. — From enrollment to Week 96."],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"vision-aging","is_published":true,"match_reasons":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"intelligence_topics":{"name":"Vision ageing","slug":"vision-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41567","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}