{"type":"trials","record":{"id":41777,"source_id":"clinicaltrials-gov","external_id":"NCT04635800","title":"A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IVT MHU650 in Macular Edema Patients","brief_summary":"This was an open-label, multi-center, FIH study with a single ascending dose (SAD) design that assessed the safety, tolerability and pharmacokinetics (PK) of a single IVT dose of MHU650 in up to 24 participants with macular edema.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Novartis Pharmaceuticals","enrollment":21,"countries":["United States","Puerto Rico"],"start_date":"2020-12-10","completion_date":"2022-05-24","last_update_date":"2025-05-18","source_url":"https://clinicaltrials.gov/study/NCT04635800","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 90 Years","comparator":null,"organization":"Novartis","interventions":["MHU650"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of participants with ocular and nonocular adverse events — Day 1 to Day 60","Change from baseline in Best Correct Visual Acuity (BCVA ) by dose level and timepoint - Study Eye — Day 1 to Day 60","Change from baseline in Central subfield thickness (CSFT) (µm) in the study eye by dose level and timepoint — Day 1 to…","Change from baseline in Intraocular pressure (IOP) (mmHg) in the study eye by dose level and timepoint — Day 1 to Day 60","Pharmacokinetics of single dose of MHU650 - Cmax — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - Tmax — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - T1/2 — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - AUClast — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - AUCinf — Days 1, 2, 5, 15, 29, 43 and 60"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Macular Edema","Diabetic Macular Edema","Neovascular Age-related Macular Degeneration","Retinal Vein Occlusion","MHU650"],"relevance_confidence":60,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Source terminology contains: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct04635800","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2020-12-10 to 2022-05-24","comparator":null,"confidence":"structured-source","population":"ALL · 18 Years to 90 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":"2026-09-25T06:20:47.869Z","intervention":["MHU650"],"participants":21,"study_design":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","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 ocular and nonocular adverse events — Day 1 to Day 60","Change from baseline in Best Correct Visual Acuity (BCVA ) by dose level and timepoint - Study Eye — Day 1 to Day 60","Change from baseline in Central subfield thickness (CSFT) (µm) in the study eye by dose level and timepoint — Day 1 to…","Change from baseline in Intraocular pressure (IOP) (mmHg) in the study eye by dose level and timepoint — Day 1 to Day 60","Pharmacokinetics of single dose of MHU650 - Cmax — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - Tmax — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - T1/2 — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - AUClast — Days 1, 2, 5, 15, 29, 43 and 60","Pharmacokinetics of single dose of MHU650 - AUCinf — Days 1, 2, 5, 15, 29, 43 and 60"],"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":["Source terminology contains: age-related macular degeneration.","Source terminology supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["controlled terminology","controlled context","study type"],"relevance_score":60,"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/41777","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}