{"type":"trials","record":{"id":41788,"source_id":"clinicaltrials-gov","external_id":"NCT05387837","title":"Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME","brief_summary":"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in subjects with Neovascular (wet) Age-Related Macular Degeneration (AMD) or subjects with Diabetic Macular Edema (DME)","overall_status":"Active Not Recruiting","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Ashvattha Therapeutics, Inc.","enrollment":50,"countries":["United States"],"start_date":"2022-08-31","completion_date":"2025-09-30","last_update_date":"2025-05-04","source_url":"https://clinicaltrials.gov/study/NCT05387837","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Active Not Recruiting. 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":"Tejas","age_range":"18 Years","comparator":null,"organization":"Ashvattha Therapeutics, Inc.","interventions":["D-4517.2"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Stage 1 Safety Evaluation — 12 weeks","Stage 1A Safety Evaluation — 40 Weeks","Stage 1: Number of participants with a reduction in sub-retinal fluid after a single intravitreal (IVT) dose of afliber…","Stage 1: Number of participants with duration of effect of D-4517.2 as assessed by changes in subretinal fluid over tim…","Stage 1: Number of participants with Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) obser…","Stage 1: Number of participants with change in best corrected visual acuity (BCVA) in study eye after each treatment (a…","Stage 1A: Effect of different D-4517.2 dose regimens to maintain BCVA and CST following a single IVT aflibercept dose —…","Stage 1A: Pharmacokinetics (Cmax) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (AUC) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (Tmax) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (CL/F) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Rescue Treatment — 12 weeks of Aflibercept and 40 weeks of D-4517.2"],"design_description":"NON RANDOMIZED · PARALLEL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Neovascular Age-related Macular Degeneration","Diabetic Macular Edema","D-4517.2"],"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:nct05387837","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-08-31 to 2025-09-30","comparator":null,"confidence":"structured-source","population":"ALL · 18 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":"2026-09-25T06:20:47.871Z","intervention":["D-4517.2"],"participants":50,"study_design":"NON RANDOMIZED · PARALLEL · TREATMENT · NONE","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":["Stage 1 Safety Evaluation — 12 weeks","Stage 1A Safety Evaluation — 40 Weeks","Stage 1: Number of participants with a reduction in sub-retinal fluid after a single intravitreal (IVT) dose of afliber…","Stage 1: Number of participants with duration of effect of D-4517.2 as assessed by changes in subretinal fluid over tim…","Stage 1: Number of participants with Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) obser…","Stage 1: Number of participants with change in best corrected visual acuity (BCVA) in study eye after each treatment (a…","Stage 1A: Effect of different D-4517.2 dose regimens to maintain BCVA and CST following a single IVT aflibercept dose —…","Stage 1A: Pharmacokinetics (Cmax) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (AUC) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (Tmax) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Pharmacokinetics (CL/F) of D-4517.2 Repeat Dosing — 24 Weeks","Stage 1A: Rescue Treatment — 12 weeks of Aflibercept and 40 weeks of D-4517.2"],"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/41788","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}