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A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

NCT02087085 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2019-04-23

Study results available
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Summary

This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.

Conditions

Interventions

DRUG

400 µg Brimonidine Implant

400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.

OTHER

Sham

Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Claire Winterson · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-09
Primary Completion
2018-03-30
Completion
2018-03-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02087085 on ClinicalTrials.gov