{"type":"trials","record":{"id":41633,"source_id":"clinicaltrials-gov","external_id":"NCT03846193","title":"FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD","brief_summary":"This was an open label first in human Phase I/II multicentre study of GT005 in subjects with Macular Atrophy due to Age-related macular degeneration (AMD).","overall_status":"Terminated","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Gyroscope Therapeutics Limited","enrollment":56,"countries":["United States","United Kingdom"],"start_date":"2018-12-17","completion_date":"2024-06-25","last_update_date":"2026-01-28","source_url":"https://clinicaltrials.gov/study/NCT03846193","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Terminated. 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":"55 Years","comparator":null,"organization":"Gyroscope Therapeutics Limited","interventions":["GT005","GT005 / Device: Orbit™ Subretinal Delivery System"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye — Adverse e…","Summary of Non-Ocular Treatment Emergent Adverse Events — Adverse events are reported from the single dose of study med…","Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred — Adve…","Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye —…","Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) L…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Poi…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)…","Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye — Up to Wee…","Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery…","Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (U…","Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye — Day 1","Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure — Day 1","Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye — Day 1","Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure — Day 1"],"design_description":"NON RANDOMIZED · SEQUENTIAL · TREATMENT · NONE","source_has_results":true},"controlled_terms":["Dry Age-related Macular Degeneration","Macular Degeneration","Retinal Disease","Eye Diseases","Retinal Degeneration","Geographic Atrophy","Macular Atrophy","GT005","GT005 / Device: Orbit™ Subretinal Delivery System"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"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:nct03846193","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2018-12-17 to 2024-06-25","comparator":null,"confidence":"structured-source","population":"ALL · 55 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":"2026-09-25T06:20:47.844Z","intervention":["GT005","GT005 / Device: Orbit™ Subretinal Delivery System"],"participants":56,"study_design":"NON RANDOMIZED · SEQUENTIAL · 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":["Ocular Treatment Emergent Adverse Events by Primary System Organ Class and Preferred Term for the Study Eye — Adverse e…","Summary of Non-Ocular Treatment Emergent Adverse Events — Adverse events are reported from the single dose of study med…","Summary of Ocular Serious Treatment-Emergent Adverse Events in the Study Eye by System Organ Class and Preferred — Adve…","Best Corrected Visual Acuity (BCVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) Letters) in the Study Eye —…","Low-Luminance Deficit Best Corrected Visual Acuity (BCVA-LLVA) (in Early Treatment Diabetic Retinopathy Study (ETDRS) L…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Bivariate Contour Ellipse…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Mean Sensitivity Decibel…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Number of Scotomatous Poi…","Macular Sensitivity Parameters by Mesopic Microperimetry (MP) Over Time in the Study Eye - MP Percent Fixation Loss (%)…","Change From Baseline Over Time in Square Root of Geographic Atrophy Area Size (mm) Via FAF in the Study Eye — Up to Wee…","Delivery of GT005 to the Subretinal Space - Rate of Successful Delivery, % (US Only) Via the Orbit Subretinal Delivery…","Delivery of Balanced Salt Solution (BSS) or BSS PLUS (BSS+) to the Subretinal Space - Rate of Successful Delivery, % (U…","Summary of Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye — Day 1","Summary of Non-Ocular Treatment-Emergent Adverse Events Related to Surgical Procedure — Day 1","Summary of Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure in the Study Eye — Day 1","Summary of Non-Ocular Serious Treatment-Emergent Adverse Events Related to Surgical Procedure — Day 1"],"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/41633","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}