A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Geographic Atrophy; Macular Degeneration
Intervention: 400 µg Brimonidine Implant (Drug); Sham (Other)
Phase: 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 study will assess the safety and efficacy of the brimonidine intravitreal implant in
patients with geographic atrophy due to age-related macular degeneration.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from Baseline in Atrophic Lesion Area in the Study Eye
Secondary outcome: Change from Baseline in Low Luminance Best Corrected Visual Acuity (BCVA) in the Study EyeChange from Baseline in BCVA in the Study Eye
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Geographic atrophy due to age-related macular degeneration in the study eye
- Visual acuity better than or equal to 20/80 in the study eye and 20/200 in the fellow
eye
Exclusion Criteria:
- Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in
the last 3 months
- Infections in either eye in the last 3 months
Locations and Contacts
Allergan Inc., Email: clinicaltrials@allergan.com
Creteil, France; Recruiting
Bonn, Germany; Recruiting
Milan, Italy; Recruiting
Frimley, United Kingdom; Recruiting
Abilene, Texas, United States; Recruiting
Arlington, Texas, United States; Recruiting
Melbourne, Victoria, Australia; Recruiting
Additional Information
More Information
Starting date: May 2014
Last updated: June 30, 2015
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