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

Phase 2

Completed

• Conditions: Glaucoma, Open-Angle
• Interventions: Drug: 400 ug Brimonidine Implant; Drug: 200 ug Brimonidine Implant; Drug: Sham (no implant)

• Registration Number: NCT00693485
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-09
• Study Start: 2008-09
• Primary Completion: 2011-01
• Study Completion: 2011-08
• Disposition First Submitted: 2012-01-26
• Disposition First Submitted QC: 2012-01-26
• Disposition First Posted: 2012-01-30
• Status Verified: 2013-03
• Results First Submitted: 2013-03-13
• Results First Submitted QC: 2013-03-13
• Last Update Submitted: 2013-03-13
• Results First Posted: 2013-04-24
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Primary open-angle glaucoma in one eye
• Visual acuity 20/80 or better
• Intraocular pressure in the study eye ≤ 24 mm Hg
• Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria

• Known allergy to brimonidine tartrate
• Uncontrolled systemic disease or infection of the eye
• Recent eye surgery or injections in the eye
• Female patients who are pregnant, nursing or planning a pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 ug Brimonidine Implant	400 ug Brimonidine Implant	400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
200 ug Brimonidine Implant	200 ug Brimonidine Implant	200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Sham (no implant)	Sham (no implant)	Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With a Visual Field Improvement in the Study Eye	Baseline, Month 6	Visual field improvement in the study eye is determined using the Humphrey Field Analyzer (HFA 24-2) full threshold test and clinical expertise. The Humphrey Field Analyzer is a machine that helps to map the field (peripheral) of vision. An improvement is an increase in the field of vision. The percentage of patients with a visual field improvement in the study eye is reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, Month 6	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.