An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Information source: Allergan
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Retinitis Pigmentosa
Intervention: Brimonidine Tartrate (Drug); Brimonidine Tartrate (Drug); Brimonidine Tartrate (Drug); Brimonidine Tartrate (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
Overall contact:
Allergan Inc., Email: clinicaltrials@allergan.com
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: Treatment, Non-Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change in Visual Acuity
Secondary outcome: Contrast sensitivityPatient questionnaires
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
Allergan Inc., Email: clinicaltrials@allergan.com
Paris, France; Recruiting
Tubingen, Germany; Recruiting
Coimbra, Portugal; Recruiting
Arlington, Texas, United States; Recruiting
Additional Information
Starting date: July 2008
Ending date: July 2010
Last updated: September 26, 2008
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