{"type":"trials","record":{"id":41869,"source_id":"clinicaltrials-gov","external_id":"NCT02307682","title":"Efficacy and Safety of RTH258 Versus Aflibercept - Study 1","brief_summary":"The purpose of this study is to compare brolucizumab (RTH258) ophthalmic solution for intravitreal (IVT) injection at two dosage levels (3 mg and 6 mg) to aflibercept ophthalmic solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.","overall_status":"Completed","phases":["PHASE3"],"study_type":"INTERVENTIONAL","sponsor":"Alcon Research","enrollment":1775,"countries":["United States"],"start_date":"2014-12-08","completion_date":"2018-03-28","last_update_date":"2025-01-16","source_url":"https://clinicaltrials.gov/study/NCT02307682","editorial_summary":"A registered PHASE3 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":"HAWK","age_range":"50 Years","comparator":"Aflibercept 2 mg","organization":"Alcon Research","interventions":["Brolucizumab ophthalmic solution","Aflibercept ophthalmic solution"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye — Baseline, Week 48","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye — Baseline, Wee…","Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 — Weeks 16, 20, 28, 32, 40, 44, 48","Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Tre…","Proportion of Subjects With Positive q12 Treatment Status up to Week 96 — Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68,…","Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need Duri…","Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye — Baseline, Weeks 4, 8, 12, 16, 20,…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye — Baseline, Weeks…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye — Baseline, Weeks…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye — Baseline, Weeks 84…","Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Ey…","Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Ey…","Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye — Baseline, Weeks 4, 8, 12, 16, 2…","Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye — Baseline, Weeks…","Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye — Baseline, Weeks 36, 40, 4…","Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye — Baseline, Weeks 84, 88, 9…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","source_has_results":true},"controlled_terms":["Neovascular Age-Related Macular Degeneration","Choroidal Neovascularization","Brolucizumab ophthalmic solution","Aflibercept ophthalmic solution"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"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:nct02307682","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2014-12-08 to 2018-03-28","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":"2026-09-25T06:20:47.883Z","intervention":["Brolucizumab ophthalmic solution","Aflibercept ophthalmic solution"],"participants":1775,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · DOUBLE","subject_scope":"Human clinical study registration","evidence_stage":"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":["Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye — Baseline, Week 48","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 36 Through Week 48 - Study Eye — Baseline, Wee…","Proportion of Subjects With Positive q12 (Every 12 Weeks) Treatment Status at Week 48 — Weeks 16, 20, 28, 32, 40, 44, 48","Proportion of Subjects With Positive q12 Treatment Status at Week 48 Within the Subjects With no q8 (Every 8 Weeks) Tre…","Proportion of Subjects With Positive q12 Treatment Status up to Week 96 — Weeks 16, 20, 28, 32, 40, 44, 52, 56, 64, 68,…","Proportion of Subjects With Positive q12 Treatment Status at Week 96 Within the Subjects With no q8 Treatment Need Duri…","Change From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Eye — Baseline, Weeks 4, 8, 12, 16, 20,…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 4 to Week 48/96 - Study Eye — Baseline, Weeks…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 12 to Week 48/96 - Study Eye — Baseline, Weeks…","Average Change From Baseline in BCVA (Letters Read) Over the Period Week 84 to Week 96 - Study Eye — Baseline, Weeks 84…","Percentage of Subjects With >=15 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=10 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=5 Letter Gain From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Ey…","Percentage of Subjects With >=15 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=10 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study E…","Percentage of Subjects With >=5 Letter Loss From Baseline in BCVA (Letters Read) at Each Post-baseline Visit - Study Ey…","Percentage of Subjects With BCVA of 73 Letters Read or More at Each Visit - Study Eye — Baseline, Weeks 4, 8, 12, 16, 2…","Change From Baseline in Central Subfield Thickness (CSFTtot) at Each Post-baseline Visit - Study Eye — Baseline, Weeks…","Average Change From Baseline in CSFTtot Over the Period Week 36 Through Week 48 - Study Eye — Baseline, Weeks 36, 40, 4…","Average Change From Baseline in CSFTtot Over the Period Week 84 Through Week 96 - Study Eye — Baseline, Weeks 84, 88, 9…"],"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/41869","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}