Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Information source: Allergan
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhegmatogenous Macula-off Retinal Detachment
Intervention: 200 μg Brimonidine Tartrate Posterior Segment Drug Delivery system (Drug); 400 μg Brimonidine Tartrate Posterior Segment Drug Delivery system (Drug); Sham Posterior Segment Drug Delivery system (Drug)
Phase: Phase 2
Status: Not yet 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 study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200
μg and 400 μg brimonidine tartrate) on visual function in patients with previous
rhegmatogenous macula-off retinal detachment.
Clinical Details
Official title: Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Best Corrected Visual Acuity (BCVA)
Secondary outcome: Mean BCVA change from baseline
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous
in etiology)
- The repair of the macula-off retinal detachment must have occurred at least 6 months
before the Day 1 visit in the study eye
- The repair must have been deemed an anatomic success and required no more than one
macular re-attachment procedure
- The visual acuity score must be between 20/50 and 20/320 in the study eye
Exclusion Criteria:
- Any sight-threatening ocular condition in the study eye other than the ruptured
retinal detachment
- Anticipated need for ocular surgery during the 12-month study period
- Any injectable, periocular, or intravitreal corticosteroid treatment to study eye
within 6 months prior to screening (eg, triamcinolone acetonide)
- Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye
within 3 months prior to screening (eg, Avastin or Lucentis)
- Any infectious condition in the study eye
Locations and Contacts
Allergan Inc, Email: clinicaltrials@allergan.com
Abilene, Texas, United States
Additional Information
Starting date: October 2009
Ending date: April 2012
Last updated: September 3, 2009
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