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: | 7/5/2018 |
| Start Date: | March 30, 2015 |
| End Date: | February 8, 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 also will generate new information on the relationship between genetics and
GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200
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 60 months.
progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration
(AMD). The study also will generate new information on the relationship between genetics and
GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200
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 60 months.
Inclusion Criteria:
- Well-demarcated area of GA secondary to AMD
- Women of childbearing potential and men must agree to use adequate contraception for
at least 30 days after fluorescein dye administration
- The study is recruiting participants in two different cohorts:
Cohort 1: Participants with unilateral GA OR Cohort 2: Participants with GA in one eye and
CNV (active or treated) with or without GA, in the contralateral eye
Exclusion Criteria:
- Previous participation in any studies of investigational drugs for GA / dry AMD
(exception 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/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
We found this trial at
12
sites
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