{"type":"trials","record":{"id":42126,"source_id":"clinicaltrials-gov","external_id":"NCT04200248","title":"A Phase II Study of RBM-007 Alone and RBM-007 With Eylea® in Subjects With Wet Age-related Macular Degeneration","brief_summary":"This is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (IVT) injections of RBM-007 monotherapy, and four monthly RBM-007 injections in combination with Eylea® dosed at every other month, compared to Eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (AMD).","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Ribomic USA Inc","enrollment":94,"countries":["United States"],"start_date":"2019-12-02","completion_date":"2021-12-22","last_update_date":"2023-06-08","source_url":"https://clinicaltrials.gov/study/NCT04200248","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. 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":"TOFU","age_range":"55 Years","comparator":"Sham + Aflibercept","organization":"Ribomic USA Inc","interventions":["RBM-007 Injectable Solution","Aflibercept","Sham"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Visual Acuity - Continuous — Week 16","Visual Acuity - Categorical — Week 16","Macular Thickness Change — Week 16","Macular Volume Change — Week 16","Fibrosis Change — Week 16","Safety - Ocular — Week 20"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":true},"controlled_terms":["Exudative Age-related Macular Degeneration","RBM-007 Injectable Solution","Aflibercept","Sham"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04200248","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-12-02 to 2021-12-22","comparator":"Sham + Aflibercept","confidence":"structured-source","population":"ALL · 55 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":"2026-09-25T06:20:47.924Z","intervention":["RBM-007 Injectable Solution","Aflibercept","Sham"],"participants":94,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","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":["Visual Acuity - Continuous — Week 16","Visual Acuity - Categorical — Week 16","Macular Thickness Change — Week 16","Macular Volume Change — Week 16","Fibrosis Change — Week 16","Safety - Ocular — Week 20"],"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":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"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/42126","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}