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Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

NCT00972374 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-04-24

Study results available
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Summary

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

Conditions

  • Rhegmatogenous Macula-off Retinal Detachment

Interventions

DRUG

400 ug Brimonidine Implant

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

DRUG

200 ug Brimonidine Implant

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

OTHER

Sham (no implant)

Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-10-31
Completion
2011-07-31

Countries

  • United States
  • India
  • Israel
  • Philippines
  • South Korea
  • United Kingdom

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 NCT00972374 on ClinicalTrials.gov