Back to resultsA Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON)
Primary Purpose
Geographic Atrophy, Macular Degeneration
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
400 µg Brimonidine Implant
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility Criteria
Inclusion Criteria:
- 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.
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
Sites / Locations
- Retinal Consultants of Arizona, Ltd., Retinal Research Institute
- Associated Retina Consultants
- University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
- Northern California Retina Vitreous Associates
- Retina Consultants of Southern Colorado, PC
- "National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
- Retina Specialty Institute
- Retina Vitreous Associates of Florida
- Southern Vitreoretinal Associates, PL
- Center for Retina and Macular Disease
- Georgia Retina
- Raj K. Maturi, MD
- Retina Associates of Western New York
- Charlotte Eye Ear Nose & Throat Associates, PA
- Oregon Retina, LLP
- Casey Eye Institute, Oregon Health and Science University
- Mid Atlantic Retina, Wills Eye Retina Surgeons
- Retina Research Institute of Texas
- Texas Retina Associates
- "Austin Retina Associates "
- Retina Foundation of the Southwest
- Valley Retina Institute
- Strategic Clinical Research Group, LLC
- Center for Eye Research Australia
- Lions Eye Institute, University of Western Australia
- Service d'Ophtalmologie
- "Centre Hospitalier Intercommunal de Creteil "
- "Universitat Bonn, Abteilung fur Augenheilkunde "
- STZ Eyetrial
- Università di Cagliari (presidio San Giovanni di Dio)
- Università di Cagliari (presidio San Giovanni di Dio)
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
- IRCCS Ospedale San Raffaele
- "Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "
- Universita degli Studi di Padova, Dipartimento di Neuroscienze
- Universita degli Studi di Torino
- Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
- Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
- Moorfields Eye Hospital
- Macular Unit, Hospital of St Cross
- Royal Hallamshire Hospital, Eye Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
400 µg Brimonidine Implant
Sham
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at 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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02087085
Brief Title
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
Acronym
BEACON
Official Title
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Study Start Date
May 9, 2014 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
March 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy, Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
310 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400 µg Brimonidine Implant
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
400 µg Brimonidine Implant
Other Intervention Name(s)
AGN-190342
Intervention Description
400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
Primary Outcome Measure Information:
Title
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
Description
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.
Time Frame
Baseline (Day 1) to Month 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
Description
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.
Time Frame
Baseline (Day 1) to Month 24
Title
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
Description
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.
Time Frame
Baseline (Day 1) to Month 24
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Retinal Sensitivity in the Study Eye
Time Frame
Baseline (Day 1) to Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Winterson
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona, Ltd., Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Consultants of Southern Colorado, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Southern Vitreoretinal Associates, PL
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Georgia Retina
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Raj K. Maturi, MD
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Oregon Retina, LLP
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Casey Eye Institute, Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Mid Atlantic Retina, Wills Eye Retina Surgeons
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
"Austin Retina Associates "
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Foundation of the Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Center for Eye Research Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Lions Eye Institute, University of Western Australia
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Service d'Ophtalmologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
"Centre Hospitalier Intercommunal de Creteil "
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
"Universitat Bonn, Abteilung fur Augenheilkunde "
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
STZ Eyetrial
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Università di Cagliari (presidio San Giovanni di Dio)
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Università di Cagliari (presidio San Giovanni di Dio)
City
Cagliari
ZIP/Postal Code
09124
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
"Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Universita degli Studi di Padova, Dipartimento di Neuroscienze
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Universita degli Studi di Torino
City
Torino
ZIP/Postal Code
10122
Country
Italy
Facility Name
Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
City
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Macular Unit, Hospital of St Cross
City
Rugby
ZIP/Postal Code
CV22 5PX
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital, Eye Department
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33383315
Citation
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.
Results Reference
derived
PubMed Identifier
32134802
Citation
Kuppermann 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.
Results Reference
derived
Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information
Learn more about this trial
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
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