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NCT00658619 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
A Phase 2 study, sponsored by Allergan.
- Completed
- Registry status
- Phase 2
- Development phase
- 119
- Enrollment target
NCT00658619: Completed Phase 2 study, sponsored by Allergan.
NCT00658619 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 119 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658619, a Phase 2 study, has completed, sponsored by Allergan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 119 participants
- Enrollment target
Study 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.
Primary Outcome
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimet
Interventions
- DRUG 400 µg Brimonidine Tartrate Implant
- DRUG 200 µg Brimonidine Tartrate Implant
- OTHER Sham (no implant)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2008-05-01 |
| Est. Completion | 2011-04-08 |
| Phase | Phase 2 |
What the finished NCT00658619 record still lists
NCT00658619 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% lower).
The record links to 0 conditions, and to 3 interventions - of which 400 µg Brimonidine Tartrate Implant is the first listed.
NCT00658619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00658619 about?
NCT00658619 is a clinical study titled "Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (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 randomi...
What is the current status of trial NCT00658619?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 119 participants. The study started on 2008-05-01. Estimated completion is 2011-04-08.
What interventions are being tested in trial NCT00658619?
The interventions under investigation include: 400 µg Brimonidine Tartrate Implant (DRUG), 200 µg Brimonidine Tartrate Implant (DRUG), Sham (no implant) (OTHER).
Who is sponsoring clinical trial NCT00658619?
This trial is sponsored by Allergan, which has 314 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00658619's enrollment target sits among peer trials
119 618th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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