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

Verified by: Allergan, January 2012
First Received: June 5, 2008 | Last Updated: January 26, 2012 | Phase: Phase 2 | Start Date: September 2008
Overall Status: Completed | Estimated Enrollment: 70
  • …
  • Tell a FriendPrint

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...

Brief 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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: January 2011

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

Outcome Measures for this Clinical Trial

Primary Measures

  • Change from Baseline in Visual Fields
    • Time Frame: Baseline, Month 6
      Safety Issue?: No

Secondary Measures

  • Change from Baseline in Visual Acuity
    • Time Frame: Baseline, Month 6
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00693485