A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
- Conditions
- Macular DegenerationGeographic Atrophy
- Interventions
- Other: ShamDrug: 400 µg Brimonidine Implant
- Registration Number
- NCT02087085
- Lead Sponsor
- Allergan
- Brief Summary
This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 310
- Geographic atrophy due to age-related macular degeneration in the study eye
- Visual acuity better than or equal to 20/125 Snellen equivalent in the study eye and 20/200 Snellen equivalent in the fellow eye.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Sham Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless drug delivery system (DDS) applicator every 3 months from Baseline (Day 1) through Month 21. 400 µg Brimonidine Implant 400 µg Brimonidine Implant 400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21.
- Primary Outcome Measures
Name Time Method Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24 Baseline (Day 1) to Month 24 GA lesion area was measured in mm\^2 by FAF in the study eye and was quantified by the central reading center. The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard Best Correct Visual Acuity (BCVA). If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression). Mixed model for repeated measures (MMRM) was used for analysis.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24 Baseline (Day 1) to Month 24 BCVA was measured using an eye chart (ETDRS) and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24 Baseline (Day 1) to Month 24 Low Luminance BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart and was reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The study eye was defined as the eye that met inclusion/exclusion criteria with the worst standard BCVA. If the BCVA in both eyes was similar the right eye was selected as the study eye. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. MMRM was used for analysis.
Trial Locations
- Locations (40)
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retinal Consultants of Arizona, Ltd., Retinal Research Institute
🇺🇸Phoenix, Arizona, United States
Raj K. Maturi, MD
🇺🇸Indianapolis, Indiana, United States
Casey Eye Institute, Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Texas Retina Associates
🇺🇸Arlington, Texas, United States
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Retina Consultants of Southern Colorado, PC
🇺🇸Colorado Springs, Colorado, United States
University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
🇺🇸La Jolla, California, United States
"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
🇺🇸Fort Myers, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Southern Vitreoretinal Associates, PL
🇺🇸Tallahassee, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Oregon Retina, LLP
🇺🇸Eugene, Oregon, United States
"Austin Retina Associates "
🇺🇸Austin, Texas, United States
Mid Atlantic Retina, Wills Eye Retina Surgeons
🇺🇸Philadelphia, Pennsylvania, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Center for Eye Research Australia
🇦🇺Melbourne, Victoria, Australia
Lions Eye Institute, University of Western Australia
🇦🇺Nedlands, Australia
Service d'Ophtalmologie
🇫🇷Bordeaux, France
"Centre Hospitalier Intercommunal de Creteil "
🇫🇷Creteil, France
Università di Cagliari (presidio San Giovanni di Dio)
🇮🇹Cagliari, Italy
STZ Eyetrial
🇩🇪Tübingen, Germany
"Universitat Bonn, Abteilung fur Augenheilkunde "
🇩🇪Bonn, Germany
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Universita degli Studi di Padova, Dipartimento di Neuroscienze
🇮🇹Padova, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy
"Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "
🇮🇹Milano, Italy
Universita degli Studi di Torino
🇮🇹Torino, Italy
Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
🇬🇧Bristol, United Kingdom
Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
🇬🇧Camberley, United Kingdom
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Macular Unit, Hospital of St Cross
🇬🇧Rugby, United Kingdom
Royal Hallamshire Hospital, Eye Department
🇬🇧Sheffield, United Kingdom
Charlotte Eye Ear Nose & Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Georgia Retina
🇺🇸Decatur, Georgia, United States
Retina Research Institute of Texas
🇺🇸Abilene, Texas, United States
Strategic Clinical Research Group, LLC
🇺🇸Willow Park, Texas, United States