Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Information source: Allergan
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Optic Neuropathy
Intervention: Brimonidine Tartrate (Drug); Brimonidine Tartrate (Drug); Sham Implant (no implant) (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc, Email: clinicaltrials@allergan.com
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in visual acuity
Secondary outcome: Change in visual fields
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 - 10 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
Allergan Inc, Email: clinicaltrials@allergan.com
Artesia, California, United States; Recruiting
Additional Information
Starting date: September 2008
Ending date: November 2011
Last updated: July 28, 2009
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