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

March 29, 2019 updated by: Allergan

Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study will assess the safety and efficacy of the brimonidine intravitreal implant in participants with geographic atrophy due to age-related macular degeneration.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) to Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 1) to Month 24
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.
Baseline (Day 1) to Month 24

Other Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Retinal Sensitivity in the Study Eye
Time Frame: Baseline (Day 1) to Month 24
Baseline (Day 1) to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Investigators

  • Study Director: Claire Winterson, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2014

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 190342-038
  • 2013-003320-36 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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