Phase 2
Completed N=70
Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Glaucoma, Open-Angle
Source: ClinicalTrials.gov NCT00693485 ↗
Enrolled (actual)
70
Serious AEs
12.9%
Results posted
Apr 2013
Primary outcomePrimary: Percentage of Patients With a Visual Field Improvement in the Study Eye — 12.0; 9.5; 4.2 Percentage of Patients
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.
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 | — |
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
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. Informational only — not medical advice.