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A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON)

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ClinicalTrials.gov Identifier: NCT02087085
Recruitment Status : Terminated
First Posted : March 14, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Macular Degeneration Drug: 400 µg Brimonidine Implant Other: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date : May 9, 2014
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 400 µg Brimonidine Implant
400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
Other Name: AGN-190342

Sham Comparator: 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.
Other: Sham
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.




Primary Outcome Measures :
  1. Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24 [ Time Frame: 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 :
  1. Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24 [ Time Frame: 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.

  2. Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24 [ Time Frame: 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.


Other Outcome Measures:
  1. Change From Baseline in Retinal Sensitivity in the Study Eye [ Time Frame: Baseline (Day 1) to Month 24 ]


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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087085


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Locations
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United States, Arizona
Retinal Consultants of Arizona, Ltd., Retinal Research Institute
Phoenix, Arizona, United States, 85014
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
United States, California
University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
La Jolla, California, United States, 92037
Northern California Retina Vitreous Associates
Mountain View, California, United States, 94040
United States, Colorado
Retina Consultants of Southern Colorado, PC
Colorado Springs, Colorado, United States, 80909
United States, Florida
"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
Fort Myers, Florida, United States, 33912
Retina Specialty Institute
Pensacola, Florida, United States, 32503
Retina Vitreous Associates of Florida
Saint Petersburg, Florida, United States, 33711
Southern Vitreoretinal Associates, PL
Tallahassee, Florida, United States, 32308
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Georgia
Georgia Retina
Decatur, Georgia, United States, 30030
United States, Indiana
Raj K. Maturi, MD
Indianapolis, Indiana, United States, 46290
United States, New York
Retina Associates of Western New York
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates, PA
Charlotte, North Carolina, United States, 28210
United States, Oregon
Oregon Retina, LLP
Eugene, Oregon, United States, 97401
Casey Eye Institute, Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Mid Atlantic Retina, Wills Eye Retina Surgeons
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Texas Retina Associates
Arlington, Texas, United States, 76012
"Austin Retina Associates "
Austin, Texas, United States, 78705
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Valley Retina Institute
McAllen, Texas, United States, 78503
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States, 76087
Australia, Victoria
Center for Eye Research Australia
Melbourne, Victoria, Australia, 3002
Australia
Lions Eye Institute, University of Western Australia
Nedlands, Australia, 6009
France
Service d'Ophtalmologie
Bordeaux, France, 33076
"Centre Hospitalier Intercommunal de Creteil "
Creteil, France, 94000
Germany
"Universitat Bonn, Abteilung fur Augenheilkunde "
Bonn, Germany, 53127
STZ Eyetrial
Tübingen, Germany, 72076
Italy
Università di Cagliari (presidio San Giovanni di Dio)
Bologna, Italy, 40138
Università di Cagliari (presidio San Giovanni di Dio)
Cagliari, Italy, 09124
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milano, Italy, 20122
IRCCS Ospedale San Raffaele
Milano, Italy, 20132
"Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "
Milano, Italy, 20157
Universita degli Studi di Padova, Dipartimento di Neuroscienze
Padova, Italy, 35128
Universita degli Studi di Torino
Torino, Italy, 10122
United Kingdom
Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
Bristol, United Kingdom, BS1 2LX
Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
Camberley, United Kingdom, GU16 7UJ
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD
Macular Unit, Hospital of St Cross
Rugby, United Kingdom, CV22 5PX
Royal Hallamshire Hospital, Eye Department
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Claire Winterson Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Statistical Analysis Plan  [PDF] August 3, 2018
Study Protocol  [PDF] May 23, 2017


Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02087085     History of Changes
Other Study ID Numbers: 190342-038
2013-003320-36 ( EudraCT Number )
First Posted: March 14, 2014    Key Record Dates
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brimonidine Tartrate
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs