{"type":"trials","record":{"id":42262,"source_id":"clinicaltrials-gov","external_id":"NCT01003691","title":"Safety And Tolerability Study Of RN6G In Subjects With Advanced Dry, Age-Related Macular Degeneration Including Geographic Atrophy","brief_summary":"The purpose of this study is to determine the safety and tolerability of multiple doses of RN6G in subjects with advanced dry, age-related macular degeneration including geographic atrophy.","overall_status":"Completed","phases":["PHASE1"],"study_type":"INTERVENTIONAL","sponsor":"Pfizer","enrollment":24,"countries":["United States"],"start_date":"2010-08-05","completion_date":"2013-04-19","last_update_date":"2022-05-12","source_url":"https://clinicaltrials.gov/study/NCT01003691","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":"60 Years to 85 Years","comparator":null,"organization":"Pfizer","interventions":["RN6G","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of Participants With Toxicity or Intolerable Dose Criteria — Baseline up to Day 304/End of Treatment (ET)","Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to Day 304/…","Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal…","Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to D…","Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Stud…","Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to…","Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to St…","Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) — Baseline up to Day…","Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day…","Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Pos…","Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,1…","Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-…","Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 8…","Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Pos…","Mean Residence Time (MRT) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24…","Systemic Clearance (CL) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24,…","Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4…","Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 1…","Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 7…","Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 1…"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":true},"controlled_terms":["Age-Related Maculopathy","Age-Related Maculopathies","Eye Diseases","Retinal Degeneration","Macular Degeneration","RN6G","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: age-related macular degeneration.","quality_checked_at":"2026-09-25T06:20:59.355028+00:00","duplicate_cluster_key":"id:nct01003691","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2010-08-05 to 2013-04-19","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years to 85 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":"2026-09-25T06:20:47.943Z","intervention":["RN6G","Placebo"],"participants":24,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","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 Toxicity or Intolerable Dose Criteria — Baseline up to Day 304/End of Treatment (ET)","Number of Participants With Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to Day 304/…","Number of Participants With Treatment Emergent Adverse Events (TEAEs): All Causalities and TEAEs Categorized by Causal…","Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to D…","Number of Participants With Ocular Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to Stud…","Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Severity — Baseline up to…","Number of Participants With Systemic Treatment Emergent Adverse Events (TEAEs) Categorized by Causal Relationship to St…","Number of Participants With Positive Anti-Drug-Antibodies (ADA) and Neutralizing Antibodies (Nab) — Baseline up to Day…","Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day…","Maximum Observed Plasma Concentration (Cmax) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Pos…","Minimum Observed Plasma Trough Concentration (Cmin) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,1…","Plasma Concentration (Css) at Steady State of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-…","Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 8…","Volume of Distribution at Steady State (Vss) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Pos…","Mean Residence Time (MRT) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24…","Systemic Clearance (CL) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4, 24,…","Plasma Decay Half-Life (t1/2) of RN6G (PF-04382923) — Pre-dose: 0 hour on Day 1, 28, 56, 84,112,140; Post-dose: 1, 2, 4…","Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 1…","Percent Change From Baseline in Plasma Total Amyloid (A) Beta (1-X) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 7…","Change From Baseline in Plasma Amyloid (A) Beta (1-40) Concentration at Day 1, 2, 7, 14, 19, 28, 45, 56, 75, 84, 103, 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":["Title contains controlled term: age-related macular degeneration.","Abstract contains controlled term: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title 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/42262","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}