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Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

NCT00658619 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2018-08-21

Study results available
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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

  • Macular Degeneration

Interventions

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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-01
Primary Completion
2010-06-01
Completion
2011-04-08

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • Philippines
  • Portugal
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658619 on ClinicalTrials.gov