CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 119 enrolled
Drug / intervention
400 µg Brimonidine Tartrate Implant +2 moredrug
Likely dose
400 µg Brimonidine Tartrate Implantfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00658619
NCT00658619Phase 2Completed
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Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Allergan·interventional·Posted Apr 15, 2008·Updated Aug 21, 2018

In Brief

A Phase 2 clinical trial evaluating 400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant, and 1 other intervention for Macular Degeneration. Completed, enrolled 119 participants across 7 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Degeneration
CountriesAustralia, Germany, Italy, Philippines, Portugal, South Korea, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 15, 2008
Enrollment StartMay 1, 2008
Primary CompletionJun 1, 2010
Study CompletionApr 8, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 18.2 years ago

Interventions

400 µg Brimonidine Tartrate Implantdrug

400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.

200 µg Brimonidine Tartrate Implantdrug

200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.

Sham (no implant)other

Sham in one or both eyes on Day 1 and Month 6.