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

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma, Open-Angle

Intervention: 400 ug Brimonidine Implant (Drug); 200 ug Brimonidine Implant (Drug); Sham (no implant) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Patients With a Visual Field Improvement in the Study Eye

Secondary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Tel Aviv, Israel

Artesia, California, United States

Additional Information

Starting date: September 2008
Last updated: March 13, 2013

Page last updated: August 20, 2015

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