{"type":"trials","record":{"id":42216,"source_id":"clinicaltrials-gov","external_id":"NCT04331730","title":"A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD","brief_summary":"This study will evaluate the efficacy and safety of AKST4290 in combination with aflibercept injections in subjects with newly diagnosed neovascular age-related macular degeneration (nAMD).","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Alkahest, Inc.","enrollment":107,"countries":["United States","Germany","Hungary","Poland"],"start_date":"2020-01-28","completion_date":"2021-09-16","last_update_date":"2022-10-26","source_url":"https://clinicaltrials.gov/study/NCT04331730","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":"PHTHALO-205","age_range":"50 Years","comparator":"Placebo + Aflibercept","organization":"Alkahest, Inc.","interventions":["AKST4290","Placebo","Aflibercept"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ET…","Time to PRN Injection (Arms 1 and 2 Only) — Baseline to Week 36","Median Number of Aflibercept Injections Received Beginning at Week 12 — Week 12 to Week 36","Percentage of Subjects With Best Corrected Visual Acuity (BCVA) Change of ≥ 15 Letters — Baseline to Week 36","Mean Change in Central Subfield Thickness (CST) Compared With Control Through Week 12 — Baseline to Week 12","Number of Participants With Adverse Events Assessed by Intensity — Screening to Week 40","Mean Change in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing M…","Time to the First Visit Where PRN Injection Criteria Are Met — Week 12 to the first visit meeting PRN injection criteri…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":true},"controlled_terms":["Neovascular Age-related Macular Degeneration","AKST4290","Placebo","Aflibercept"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Abstract contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04331730","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-01-28 to 2021-09-16","comparator":"Placebo + Aflibercept","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":"2026-09-25T06:20:47.936Z","intervention":["AKST4290","Placebo","Aflibercept"],"participants":107,"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":["Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ET…","Time to PRN Injection (Arms 1 and 2 Only) — Baseline to Week 36","Median Number of Aflibercept Injections Received Beginning at Week 12 — Week 12 to Week 36","Percentage of Subjects With Best Corrected Visual Acuity (BCVA) Change of ≥ 15 Letters — Baseline to Week 36","Mean Change in Central Subfield Thickness (CST) Compared With Control Through Week 12 — Baseline to Week 12","Number of Participants With Adverse Events Assessed by Intensity — Screening to Week 40","Mean Change in Best Corrected Visual Acuity (BCVA) Per the Early Treatment Diabetic Retinopathy Study (ETDRS) Testing M…","Time to the First Visit Where PRN Injection Criteria Are Met — Week 12 to the first visit meeting PRN injection criteri…"],"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":["Abstract contains controlled term: age-related macular degeneration.","Source terminology contains: age-related macular degeneration.","Abstract supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["abstract","controlled terminology","abstract 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/42216","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}