{"type":"trials","record":{"id":41460,"source_id":"clinicaltrials-gov","external_id":"NCT07160179","title":"Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","brief_summary":"Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration ABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US. Participants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","overall_status":"Recruiting","phases":["PHASE1","PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"AbbVie","enrollment":66,"countries":["United States"],"start_date":"2025-08-13","completion_date":"2029-10-01","last_update_date":"2026-07-13","source_url":"https://clinicaltrials.gov/study/NCT07160179","editorial_summary":"A registered PHASE1, PHASE2 study indexed because it matched monitored longevity research terms. Registry status: 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":null,"age_range":"50 Years","comparator":null,"organization":"AbbVie","interventions":["ABBV-6628","SYFOVRE"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Number of Participants Experiencing Adverse Events — Up to approximately 25 months","Number of Participants with Abnormal Change in Physical Examinations — Up to approximately 25 months","Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements — Up to approximately 25 months","Change From Baseline in Electrocardiograms (ECGs) — Up to approximately 25 months","Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed — Up t…","Change from baseline in Best Corrected Visual Acuity (BCVA) — Up to approximately 25 months","Change in Slit lamp biomicroscopy assessment — Up to approximately 25 months","Change in Intraocular pressure (IOP) — Up to approximately 25 months","Change in Lens examination assessment — Up to approximately 25 months","Change in Ophthalmoscopy assessment — Up to approximately 25 months","Change in fundus autofluorescence (FAF) imaging assessed by Investigator — Up to approximately 25 months","Change in Retinal evaluation — Up to approximately 25 months","Change in spectral domain optical coherence tomography (SD-OCT) — Up to approximately 25 months","Change in Fluorescein angiography (FA) assessed by Investigator. — Up to approximately 25 months","Change in choroidal neovascularization (CNV) assessed by Investigator. — Up to approximately 25 months","Percentage of Participants with Clinically Significant Post-treatment Administration Assessment (study eye only) Findin…","Maximum Serum Concentration (Cmax) of ABBV-6628 — Up to approximately 25 months","Time to Cmax (Tmax) of ABBV-6628 — Up to approximately 25 months","Area Under the Concentration-Time Curve From zero to the last measurable Timepoint (AUC0-Tlast) of ABBV-6628 — Up to ap…","Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628 — Up to approximately 12 months"],"design_description":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Geographic Atrophy","Age-Related Macular Degeneration","ABBV-6628","SYFOVRE"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":100,"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:nct07160179","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2025-08-13 to 2029-10-01","comparator":null,"confidence":"structured-source","population":"ALL · 50 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":"2026-09-25T06:20:47.816Z","intervention":["ABBV-6628","SYFOVRE"],"participants":66,"study_design":"RANDOMIZED · SEQUENTIAL · TREATMENT · QUADRUPLE","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":["Number of Participants Experiencing Adverse Events — Up to approximately 25 months","Number of Participants with Abnormal Change in Physical Examinations — Up to approximately 25 months","Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements — Up to approximately 25 months","Change From Baseline in Electrocardiograms (ECGs) — Up to approximately 25 months","Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed — Up t…","Change from baseline in Best Corrected Visual Acuity (BCVA) — Up to approximately 25 months","Change in Slit lamp biomicroscopy assessment — Up to approximately 25 months","Change in Intraocular pressure (IOP) — Up to approximately 25 months","Change in Lens examination assessment — Up to approximately 25 months","Change in Ophthalmoscopy assessment — Up to approximately 25 months","Change in fundus autofluorescence (FAF) imaging assessed by Investigator — Up to approximately 25 months","Change in Retinal evaluation — Up to approximately 25 months","Change in spectral domain optical coherence tomography (SD-OCT) — Up to approximately 25 months","Change in Fluorescein angiography (FA) assessed by Investigator. — Up to approximately 25 months","Change in choroidal neovascularization (CNV) assessed by Investigator. — Up to approximately 25 months","Percentage of Participants with Clinically Significant Post-treatment Administration Assessment (study eye only) Findin…","Maximum Serum Concentration (Cmax) of ABBV-6628 — Up to approximately 25 months","Time to Cmax (Tmax) of ABBV-6628 — Up to approximately 25 months","Area Under the Concentration-Time Curve From zero to the last measurable Timepoint (AUC0-Tlast) of ABBV-6628 — Up to ap…","Stage 2-Trough serum concentration immediately before next dose (Ctrough) of ABBV-6628 — Up to approximately 12 months"],"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.","Source terminology contains: age-related macular degeneration.","Title supplies longevity context: age-related.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","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/41460","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}