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
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.
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Tel Aviv, Israel
Artesia, California, United States
Additional Information
Starting date: September 2008
Last updated: March 13, 2013
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