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Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy

NCT00693485 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-04-24

Study results available
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Summary

A multicenter, randomized, patient-masked, sham-controlled evaluation of the safety and effects on visual function of brimonidine intravitreal implant in patients with glaucomatous optic neuropathy. Patients will be followed for up to 1 year.

Conditions

  • Glaucoma, Open-Angle

Interventions

DRUG

400 ug Brimonidine Implant

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

DRUG

200 ug Brimonidine Implant

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

DRUG

Sham (no implant)

Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in 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
2008-09-30
Primary Completion
2011-01-31
Completion
2011-08-31

Countries

  • United States
  • Israel

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 NCT00693485 on ClinicalTrials.gov