Actively Recruiting
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
Led by AbbVie · Updated on 2026-02-12
66
Participants Needed
4
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with geographic atrophy secondary to age-related macular degeneration in the study eye
- For Stage 1: Foveal or non-foveal geographic atrophy with total lesion area ≥ 0.5 DA (1.25 mm2) in the study eye
- For Stage 1: No choroidal neovascularization in the study eye
- For Stage 2: Non-foveal geographic atrophy with total lesion area of 1 to 7 DA (2.5 to 17.5 mm2) within 0.5 to 1.5 mm from the fovea center in the study eye
- For Stage 2: No choroidal neovascularization in both eyes
You will not qualify if you...
- History of recurrent or active ocular or intraocular inflammation such as uveitis or endophthalmitis in at least one eye
- Active periocular, ocular, or intraocular infection in at least one eye
- History or signs of diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases besides age-related macular degeneration in at least one eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Retina Partners Midwest, P.C. /ID# 262172
Carmel, Indiana, United States, 46032
Actively Recruiting
2
Retina Research Institute of Texas /ID# 262141
Abilene, Texas, United States, 79606-1224
Actively Recruiting
3
Retina Foundation of the Southwest /ID# 262479
Dallas, Texas, United States, 75231
Actively Recruiting
4
Retina Consultants - The Woodlands /ID# 262138
The Woodlands, Texas, United States, 77384
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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