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

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinitis Pigmentosa

Intervention: 400 µg Brimonidine Tartrate Implant (Drug); 200 µg Brimonidine Tartrate Implant (Drug); 100 µg Brimonidine Tartrate Implant (Drug); Sham (no implant) (Other)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

Secondary outcome: Change From Baseline in Contrast Sensitivity in the Study Eye


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Significant near-sightedness


- Female patients who are pregnant, nursing, or planning pregnancy

Locations and Contacts

Paris, France

Tubingen, Germany

Coimbra, Portugal

Arlington, Texas, United States

Additional Information

Starting date: July 2008
Last updated: March 13, 2013

Page last updated: August 20, 2015

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