{"type":"trials","record":{"id":87103,"source_id":"isrctn","external_id":"ISRCTN59733193","title":"ReNEW: a clinical trial investigating the efficacy and safety of elamipretide in subjects who have dry age-related macular degeneration (Dry AMD)","brief_summary":"The main objective of the trial is to evaluate the efficacy of daily injections of elamipretide in subjects who have dry age-related macular degeneration (AMD). The secondary objectives are as follows: 1. To evaluate how safe and tolerable the daily injections of elamipretide are for the subjects 2. To evaluate the pharmacokinetic (PK) profile of elamipretide and its metabolites. That is, how the body deals with the drug, including concentration of the drug in the blood stream, how the body breaks the drug down and how long the it takes for the body to remove the drug or its breakdown products","overall_status":"Recruiting","phases":["Phase III"],"study_type":"Interventional","sponsor":"Stealth BioTherapeutics (United States)","enrollment":313,"countries":["United States of America","United Kingdom","New Zealand","Czech Republic","Germany","Hungary","Italy","Spain"],"start_date":"2024-05-30","completion_date":"2027-08-01","last_update_date":"2025-11-05","source_url":"https://www.isrctn.com/ISRCTN59733193","editorial_summary":"A registered Phase III study indexed because it matched monitored longevity research terms. Registry status: Recruiting. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T03:46:39.792962+00:00","last_seen_at":"2026-09-25T04:04:16.009+00:00","metadata":{"sex":"All","age_range":"Adult","comparator":null,"attribution":"Source: ISRCTN ISRCTN59733193; retrieved 2026-09-25","interventions":["Elamipretide [D-Arginyl-2’,6’-dimethyl-L-tyrosyl- L –lysyl- L –phenylalaninamide (free base)]","Drug"],"reuse_license":"Registry contribution CC BY 4.0; generated metadata CC0","registry_source":"ISRCTN","outcome_measures":["The rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone-Retinal Pigment Epithelium t…","1. Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT…"],"design_description":"Interventional","source_has_results":false},"controlled_terms":["Dry age-related macular degeneration (dry AMD)","Subjects will be randomized (2:1) to once daily 40 mg SC of elamipretide or placebo for 96 weeks of treatment, by an on…","Study website","Elamipretide [D-Arginyl-2’,6’-dimethyl-L-tyrosyl- L –lysyl- L –phenylalaninamide (free base)]","Drug"],"relevance_confidence":100,"source_quality_score":98,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T04:04:25.705398+00:00","duplicate_cluster_key":"id:isrctn59733193","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-05-30 to 2027-08-01","comparator":null,"confidence":"structured-source","population":"All · Adult","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":"2026-09-25T04:04:16.047Z","intervention":["Elamipretide [D-Arginyl-2’,6’-dimethyl-L-tyrosyl- L –lysyl- L –phenylalaninamide (free base)]","Drug"],"participants":313,"study_design":"Interventional","subject_scope":"Human clinical study registration","evidence_stage":"Phase III","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":["The rate of change in the macular area of photoreceptor loss (defined as an Ellipsoid Zone-Retinal Pigment Epithelium t…","1. Rate of change in the macular area of photoreceptor loss (defined as an EZ-RPE thickness of 0μm) assessed by SD-OCT…"],"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":"ISRCTN Registry","homepage_url":"https://www.isrctn.com/"}},"canonical_url":"https://www.immortal.life/trials/87103","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}