Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 8/23/2018 |
| Start Date: | May 1, 2008 |
| End Date: | April 8, 2011 |
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal
implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment)
in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1.
Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the
safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy
from age-related macular degeneration. Patients will be followed for up to 2 years.
implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment)
in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1.
Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the
safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy
from age-related macular degeneration. Patients will be followed for up to 2 years.
Inclusion Criteria:
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
Exclusion Criteria:
- Known allergy to brimonidine
- Uncontrolled systemic disease or infection of the eye
- Recent eye surgery or injections in the eye
- Female patients who are pregnant, nursing or planning a pregnancy
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