Status:
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
Lead Sponsor:
AbbVie
Conditions:
Geographic Atrophy
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
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 o...
Eligibility Criteria
Inclusion
- Stage 1 and Stage 2
- 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
- Stage 1 and Stage 2
- 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.
Key Trial Info
Start Date :
August 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07160179
Start Date
August 13 2025
End Date
October 1 2029
Last Update
November 6 2025
Active Locations (3)
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1
Retina Partners Midwest, P.C. /ID# 262172
Carmel, Indiana, United States, 46032
2
Retina Research Institute of Texas /ID# 262141
Abilene, Texas, United States, 79606-1224
3
Retina Foundation of the Southwest /ID# 262479
Dallas, Texas, United States, 75231