Phase 2 N=70 Randomized Triple-blind Treatment

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

Glaucoma, Open-Angle

Bottom Line

View on ClinicalTrials.gov: NCT00693485 ↗

Enrolled (actual)

Serious AEs

12.9%

Results posted

Apr 2013

Primary outcome: Primary: Percentage of Patients With a Visual Field Improvement in the Study Eye — 12.0; 9.5; 4.2 Percentage of Patients

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 400 ug Brimonidine Implant (Drug); 200 ug Brimonidine Implant (Drug); Sham (no implant) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With a Visual Field Improvement in the Study Eye	12.0; 9.5; 4.2	—
SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	76.0; 80.6; 77.3; 2.8; -2.2; 0.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00693485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.