A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Status: | Terminated |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 8/23/2018 |
Start Date: | June 24, 2015 |
End Date: | January 31, 2018 |
A Multicenter, Prospective Epidemiologic Study of The Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration
This study seeks to better characterize relationships between visual function and the
progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration
(AMD). The study is also intended to generate new information on the relationship between
genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study
enrolling participants with GA secondary to AMD. The study visits are scheduled to occur
every 6 months. The anticipated duration of the study is up to 48 months. There is a planned
interim analysis around the 2-year time window for the study.
progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration
(AMD). The study is also intended to generate new information on the relationship between
genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study
enrolling participants with GA secondary to AMD. The study visits are scheduled to occur
every 6 months. The anticipated duration of the study is up to 48 months. There is a planned
interim analysis around the 2-year time window for the study.
Inclusion Criteria:
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods that result in a failure rate
of less than (<) 1 percent (%) per year for at least 30 days after the last
fluorescein dye administration
- The study is being conducted in participants with GA in both Study Eye and Non-Study
Eye (bilateral GA) with no evidence of prior or active choroidal neovascularization
(CNV)
Exclusion Criteria:
- Previous participation in any studies of investigational drugs for GA or dry AMD
(except for studies of vitamins and minerals)
- GA in either eye due to causes other than AMD
- History of vitrectomy surgery, submacular surgery, or any surgical intervention for
AMD
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
occlusion, and/or proliferative diabetic retinopathy
- Any ocular or systemic medical conditions that, in the opinion of the investigator,
could contribute to participant's inability to participate in the study or interfere
with study assessments
- Requirement for continuous use of therapy indicated in Prohibited Therapy in the study
Protocol
We found this trial at
24
sites
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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