{"type":"trials","record":{"id":42273,"source_id":"clinicaltrials-gov","external_id":"NCT02867735","title":"A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema","brief_summary":"To evaluate the safety and tolerability of LKA651 in patients with macular edema from diabetic macular edema (DME), neovascular age-related macular degeneration (AMD), or retinal vein occlusions (RVO)","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":28,"countries":["United States","Puerto Rico"],"start_date":"2016-09-21","completion_date":"2018-02-15","last_update_date":"2022-04-15","source_url":"https://clinicaltrials.gov/study/NCT02867735","editorial_summary":"A registered PHASE1 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":null,"age_range":"18 Years to 85 Years","comparator":null,"organization":"Novartis","interventions":["LKA651","Sham Comparator"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number Of participants with Adverse Events as a measure of Safety and Tolerability — Day 1 through study completion","Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC) — Plasma samples were collected at Days 1,2,5,8,…","Pharmacokinetics of Single Dose of LKA651 - Cmax — Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85"],"design_description":"NA · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Macular Edema","Diabetic Macular Edema","Neovascular Age-related Macular Degeneration","Retinal Vein Occlusions","LKA651","Sham Comparator"],"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:nct02867735","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2016-09-21 to 2018-02-15","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years to 85 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":"2026-09-25T06:20:47.944Z","intervention":["LKA651","Sham Comparator"],"participants":28,"study_design":"NA · SEQUENTIAL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1","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":["Number Of participants with Adverse Events as a measure of Safety and Tolerability — Day 1 through study completion","Pharmacokinetics of Single Dose of LKA651 - Area Under the Curve (AUC) — Plasma samples were collected at Days 1,2,5,8,…","Pharmacokinetics of Single Dose of LKA651 - Cmax — Plasma samples were collected at Days 1,2,5,8,15,29,43,57,71,85"],"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/42273","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}