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
Summary
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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Paris, France
Tubingen, Germany
Coimbra, Portugal
Arlington, Texas, United States
Additional Information
Starting date: July 2008
Last updated: March 13, 2013
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