An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

Intervention(s) in this Clinical Trial

• Drug: Brimonidine Tartrate
  • Group A: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
• Drug: Brimonidine Tartrate
  • Group B: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
• Drug: Brimonidine Tartrate
  • Group B: 200 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
• Drug: Brimonidine Tartrate
  • Group B: 400 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Group A: 100 µg Brimonidine implant in study eye and sham in fellow eye
• Experimental: 2
  • Group B: 100 µg Brimonidine implant in study eye and sham in fellow eye
• Experimental: 3
  • Group B: 200 µg Brimonidine implant in study eye and sham in fellow eye
• Experimental: 4
  • Group B: 400 µg Brimonidine implant in study eye and sham in fellow eye

Primary Measures

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

Secondary Measures

• Contrast sensitivity
  • Time Frame: Day 1 - Month 12
    Safety Issue?: No
• Patient questionnaires
  • Time Frame: Day 1 - Month 12
    Safety Issue?: No

Inclusion Criteria:

• Retinitis Pigmentosa in both eyes
• Visual acuity between 20/40 to count fingers

Exclusion Criteria:

• Growth of new blood vessels in the eye
• Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
• Any ocular disease that can interfere with diagnosis and or assessment of disease progression
• Significant near-sightedness
• HIV
• Female patients who are pregnant, nursing, or planning 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

Lead Investigator: Allergan Industry

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00661479

Study ID Number: 190342-028D

ClinicalTrials.gov Identifier: NCT00661479

Health Authority: United States: Food and Drug Administration