{"type":"trials","record":{"id":42306,"source_id":"clinicaltrials-gov","external_id":"NCT03953079","title":"A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD","brief_summary":"Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Graybug Vision","enrollment":56,"countries":["United States"],"start_date":"2019-09-26","completion_date":"2021-06-03","last_update_date":"2022-01-19","source_url":"https://clinicaltrials.gov/study/NCT03953079","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":"ALTISSIMO","age_range":"50 Years","comparator":"Aflibercept 2 mg","organization":"Graybug Vision","interventions":["Drug: GB-102","Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Time to First Rescue Treatment — Baseline through 12 months","Time to Fulfillment of at Least One Rescue Criterion — 6 months through 12 months","Number of Times That at Least One Rescue Criterion is Met — Baseline through 12 months","Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study — Baseline through 12 mont…","Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits — Baseline through 12 mo…","Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits — Baseline through 12 months","Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits — Baseline through 12 months","Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits — Baseline through 12 months","Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits — Baseline th…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","source_has_results":true},"controlled_terms":["Neovascular Age-Related Macular Degeneration","Drug: GB-102","Aflibercept"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":50,"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:nct03953079","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2019-09-26 to 2021-06-03","comparator":"Aflibercept 2 mg","confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.949Z","intervention":["Drug: GB-102","Aflibercept"],"participants":56,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · SINGLE","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":["Time to First Rescue Treatment — Baseline through 12 months","Time to Fulfillment of at Least One Rescue Criterion — 6 months through 12 months","Number of Times That at Least One Rescue Criterion is Met — Baseline through 12 months","Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study — Baseline through 12 mont…","Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits — Baseline through 12 mo…","Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits — Baseline through 12 months","Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits — Baseline through 12 months","Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits — Baseline through 12 months","Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits — Baseline th…"],"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/42306","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}