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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 is a Phase 2 study that has completed, run by Allergan. The registered enrollment target is 119 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00658619
The ClinicalTrials.gov registry entry for NCT00658619 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allergan, which has 314 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 400 µg Brimonidine Tartrate Implant is the first listed.
NCT00658619 reports 0 study locations.
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.
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