{"type":"trials","record":{"id":41453,"source_id":"clinicaltrials-gov","external_id":"NCT06164587","title":"Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy","brief_summary":"This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Number of participants has been expanded to 30. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.","overall_status":"Completed","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Inflammasome Therapeutics","enrollment":30,"countries":["United States"],"start_date":"2024-04-18","completion_date":"2026-05-15","last_update_date":"2026-07-20","source_url":"https://clinicaltrials.gov/study/NCT06164587","editorial_summary":"A registered PHASE1, PHASE2 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":"K8 for GA","age_range":"50 Years to 99 Years","comparator":null,"organization":"Inflammasome Therapeutics","interventions":["K8"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Adverse Events — Within the study period (of 26 weeks)","Mean change in best-corrected visual acuity (BCVA) — At baseline visit, week 13 visit, and week 26 visit","Mean change in low-luminance best-corrected visual acuity (ll-BCVA) — At baseline visit, week 13 visit, and week 26 vis…","Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) — At baseline visit, week 13 visit, and week…","change in size of geographic atrophy (GA) on optical coherence tomography (OCT) — At baseline visit, week 13 visit, and…","change in size of geographic atrophy (GA) on fluorescein angiogram (FA) — At baseline visit, week 13 visit, and week 26…","Change in multifocal electroretinograms (mfERG) response — At baseline visit, week 13 visit, and week 26 visit","Change in microperimetry response — At baseline visit, week 13 visit, and week 26 visit","Change in reading speed — At baseline visit, week 13 visit, and week 26 visit","Discontinued subjects — This will be done at every scheduled visit and any unscheduled visit, as well as when reported…","Change in best corrected visual acuity (BCVA) over multiple time points — Day 2 visit, Week 4 visit, Week 13 visit, Wee…"],"design_description":"NA · SINGLE GROUP · TREATMENT · NONE","source_has_results":false},"controlled_terms":["Geographic Atrophy","Age-Related Macular Degeneration","K8"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct06164587","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-04-18 to 2026-05-15","comparator":null,"confidence":"structured-source","population":"ALL · 50 Years to 99 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":"2026-09-25T06:20:47.815Z","intervention":["K8"],"participants":30,"study_design":"NA · SINGLE GROUP · TREATMENT · NONE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE1, 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":["Adverse Events — Within the study period (of 26 weeks)","Mean change in best-corrected visual acuity (BCVA) — At baseline visit, week 13 visit, and week 26 visit","Mean change in low-luminance best-corrected visual acuity (ll-BCVA) — At baseline visit, week 13 visit, and week 26 vis…","Change in size of geographic atrophy (GA) on fundus autofluorescence (FAF) — At baseline visit, week 13 visit, and week…","change in size of geographic atrophy (GA) on optical coherence tomography (OCT) — At baseline visit, week 13 visit, and…","change in size of geographic atrophy (GA) on fluorescein angiogram (FA) — At baseline visit, week 13 visit, and week 26…","Change in multifocal electroretinograms (mfERG) response — At baseline visit, week 13 visit, and week 26 visit","Change in microperimetry response — At baseline visit, week 13 visit, and week 26 visit","Change in reading speed — At baseline visit, week 13 visit, and week 26 visit","Discontinued subjects — This will be done at every scheduled visit and any unscheduled visit, as well as when reported…","Change in best corrected visual acuity (BCVA) over multiple time points — Day 2 visit, Week 4 visit, Week 13 visit, Wee…"],"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: aging, 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/41453","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}