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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

RecruitingPhase 1, Phase 2Ages 50 Years - anyAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 pa

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 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 โ‰ฅ 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: 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.
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What it tests

  • ABBV-6628
  • SYFOVRE
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Where

5 sites
Retina Partners Midwest, P.C. /ID# 262172
Carmel, United States
Sierra Eye Associates /ID# 262142
Reno, United States
Retina Research Institute of Texas /ID# 262141
Abilene, United States
Retina Foundation of the Southwest /ID# 262479
Dallas, United States
Retina Consultants - The Woodlands /ID# 262138
The Woodlands, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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