Trials / Completed
CompletedNCT00658619
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 400 µg Brimonidine Tartrate Implant | 400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| DRUG | 200 µg Brimonidine Tartrate Implant | 200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6. |
| OTHER | Sham (no implant) | Sham in one or both eyes on Day 1 and Month 6. |
Timeline
- Start date
- 2008-05-01
- Primary completion
- 2010-06-01
- Completion
- 2011-04-08
- First posted
- 2008-04-15
- Last updated
- 2018-08-21
- Results posted
- 2013-04-26
Locations
7 sites across 7 countries: United States, Australia, Germany, Italy, Philippines, Portugal, South Korea
Source: ClinicalTrials.gov record NCT00658619. Inclusion in this directory is not an endorsement.