A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
BEACON
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
2 other identifiers
interventional
310
6 countries
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2014
Typical duration for phase_2
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedStudy Start
First participant enrolled
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedResults Posted
Study results publicly available
April 23, 2019
CompletedApril 23, 2019
March 1, 2019
3.9 years
March 12, 2014
March 29, 2019
March 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at 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.
Baseline (Day 1) to Month 24
Secondary Outcomes (2)
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
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
Baseline (Day 1) to Month 24
Other Outcomes (1)
Change From Baseline in Retinal Sensitivity in the Study Eye
Baseline (Day 1) to Month 24
Study Arms (2)
400 µg Brimonidine Implant
EXPERIMENTAL400 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.
Sham
SHAM COMPARATORSham 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.
Interventions
400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (41)
Retinal Consultants of Arizona, Ltd., Retinal Research Institute
Phoenix, Arizona, 85014, United States
Associated Retina Consultants
Phoenix, Arizona, 85020, United States
University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
La Jolla, California, 92037, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, 80909, United States
"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
Fort Myers, Florida, 33912, United States
Retina Specialty Institute
Pensacola, Florida, 32503, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Associates, PL
Tallahassee, Florida, 32308, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Georgia Retina
Decatur, Georgia, 30030, United States
Raj K. Maturi, MD
Indianapolis, Indiana, 46290, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Oregon Retina, LLP
Eugene, Oregon, 97401, United States
Casey Eye Institute, Oregon Health and Science University
Portland, Oregon, 97239, United States
Mid Atlantic Retina, Wills Eye Retina Surgeons
Philadelphia, Pennsylvania, 19107, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Arlington, Texas, 76012, United States
"Austin Retina Associates "
Austin, Texas, 78705, United States
Retina Foundation of the Southwest
Dallas, Texas, 75231, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Center for Eye Research Australia
Melbourne, Victoria, 3002, Australia
Lions Eye Institute, University of Western Australia
Nedlands, 6009, Australia
Service d'Ophtalmologie
Bordeaux, 33076, France
"Centre Hospitalier Intercommunal de Creteil "
Créteil, 94000, France
"Universitat Bonn, Abteilung fur Augenheilkunde "
Bonn, 53127, Germany
STZ Eyetrial
Tübingen, 72076, Germany
Università di Cagliari (presidio San Giovanni di Dio)
Bologna, 40138, Italy
Università di Cagliari (presidio San Giovanni di Dio)
Cagliari, 09124, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
"Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "
Milan, 20157, Italy
Universita degli Studi di Padova, Dipartimento di Neuroscienze
Padua, 35128, Italy
Universita degli Studi di Torino
Torino, 10122, Italy
Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
Bristol, BS1 2LX, United Kingdom
Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
Camberley, GU16 7UJ, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Macular Unit, Hospital of St Cross
Rugby, CV22 5PX, United Kingdom
Royal Hallamshire Hospital, Eye Department
Sheffield, S10 2JF, United Kingdom
Related Publications (2)
Miere A, Capuano V, Kessler A, Zambrowski O, Jung C, Colantuono D, Pallone C, Semoun O, Petit E, Souied E. Deep learning-based classification of retinal atrophy using fundus autofluorescence imaging. Comput Biol Med. 2021 Mar;130:104198. doi: 10.1016/j.compbiomed.2020.104198. Epub 2020 Dec 28.
PMID: 33383315DERIVEDKuppermann BD, Patel SS, Boyer DS, Augustin AJ, Freeman WR, Kerr KJ, Guo Q, Schneider S, Lopez FJ; Brimo DDS Gen 1 Study Group. PHASE 2 STUDY OF THE SAFETY AND EFFICACY OF BRIMONIDINE DRUG DELIVERY SYSTEM (BRIMO DDS) GENERATION 1 IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2021 Jan 1;41(1):144-155. doi: 10.1097/IAE.0000000000002789.
PMID: 32134802DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area, Head
- Organization
- Allergan
Study Officials
- STUDY DIRECTOR
Claire Winterson
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 12, 2014
First Posted
March 14, 2014
Study Start
May 9, 2014
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
April 23, 2019
Results First Posted
April 23, 2019
Record last verified: 2019-03