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
NCT ID: NCT07160179
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2025-08-13
2029-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABBV-6628: Stage 1-Cohort 1
Participants will receive a single dose of ABBV-6628 in Cohort 1 on day 1.
ABBV-6628
Intravitreal injection
ABBV-6628: Stage 1 -Cohort 2
Participants will receive a single dose of ABBV-6628 in Cohort 2 on day 1.
ABBV-6628
Intravitreal injection
ABBV-6628: Stage 1 -Cohort 3
Participants will receive a single dose of ABBV-6628 in Cohort 3 on day 1.
ABBV-6628
Intravitreal injection
ABBV-6628: Stage 1 -Cohort 4
Participants will receive ABBV-6628 in Cohort 4 on day 1 and month 2.
ABBV-6628
Intravitreal injection
ABBV-6628: Stage 2
Participants will receive ABBV-6628 for approximately 22 months followed by 3 months of follow-up.
ABBV-6628
Intravitreal injection
SYFOVRE: Stage 2
Participants will receive SYFOVRE for approximately 22 months followed by 3 months of follow-up.
SYFOVRE
Intravitreal injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABBV-6628
Intravitreal injection
SYFOVRE
Intravitreal injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
-Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye.
Stage 1
* Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1
* Absence of choroidal neovascularization (CNV) in the study eye as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline/Day 1.
Stage 2
* Non-foveal GA with total lesion area of 1 to 7 DA (2.5 to 17.5 mm2); within 0.5 to 1.5 mm from fovea center in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1.
* Absence of CNV in both eyes as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline/Day 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline/Day 1.
Exclusion Criteria
* History of recurrent or currently active ocular or intraocular inflammation (e.g., uveitis, endophthalmitis) in at least one eye at Screening and Baseline/Day 1.
* Active periocular, ocular, or intraocular infection in at least one eye at Baseline/Day 1.
* History or clinical signs of diabetic retinopathy, diabetic macular edema (DME), or any retinal vascular disease other than AMD in at least one eye at Screening and Baseline/Day 1.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retina Partners Midwest, P.C. /ID# 262172
Carmel, Indiana, United States
Retina Research Institute of Texas /ID# 262141
Abilene, Texas, United States
Retina Foundation of the Southwest /ID# 262479
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site Coordinator
Role: primary
Site Coordinator
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M24-204
Identifier Type: -
Identifier Source: org_study_id