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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

• Drug: Brimonidine Tartrate
  • 200 µg Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye
• Drug: Brimonidine Tartrate
  • 400 µg Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye
• Drug: Sham Implant (no implant)
  • Sham Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye (meaning no treatment)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 200 µg Brimonidine Implant in study eye
• Experimental: 2
  • 400 µg Brimonidine Implant in study eye
• Sham Comparator: 3
  • Sham in study eye (no implant)

Primary Measures

• Change in visual acuity
  • Time Frame: Month 6
    Safety Issue?: No

Secondary Measures

• Change in visual fields
  • Time Frame: Day 1 - Month 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Overall Contact: Allergan Inc  clinicaltrials@allergan.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693485

Study ID Number: 190342-030D

ClinicalTrials.gov Identifier: NCT00693485

Health Authority: United States: Food and Drug Administration