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Geographic AtrophyPhase 2BEACONNCT02087085

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

A Phase 2 study testing 400 µg Brimonidine Implant in people with Geographic Atrophy and Macular Degeneration, run by Allergan at 41 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Geographic Atrophy, Macular Degeneration
What is being tested?
400 µg Brimonidine Implant
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
310 participants
Where
41 sitesin 6 countries
Study dates
9 May 2014to 30 Mar 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

United States23 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Texas Retina Associates

    Arlington, Texas, 76012

  • "Austin Retina Associates "

    Austin, Texas, 78705

  • Charlotte Eye Ear Nose & Throat Associates, PA

    Charlotte, North Carolina, 28210

  • Retina Consultants of Southern Colorado, PC

    Colorado Springs, Colorado, 80909

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Georgia Retina

    Decatur, Georgia, 30030

  • Oregon Retina, LLP

    Eugene, Oregon, 97401

  • "National Ophthalmic Research Institute Retina Consultants of Southwest Florida"

    Fort Myers, Florida, 33912

  • Raj K. Maturi, MD

    Indianapolis, Indiana, 46290

  • University of California, San Diego, Jacobs Retina Center, Shiley Eye Center

    La Jolla, California, 92037

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina, Wills Eye Retina Surgeons

    Philadelphia, Pennsylvania, 19107

  • Retinal Consultants of Arizona, Ltd., Retinal Research Institute

    Phoenix, Arizona, 85014

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Casey Eye Institute, Oregon Health and Science University

    Portland, Oregon, 97239

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Retina Vitreous Associates of Florida

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Associates, PL

    Tallahassee, Florida, 32308

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Italy7 sites

  • Università di Cagliari (presidio San Giovanni di Dio)

    Bologna, 40138

  • Università di Cagliari (presidio San Giovanni di Dio)

    Cagliari, 09124

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • "Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "

    Milan, 20157

  • Universita degli Studi di Padova, Dipartimento di Neuroscienze

    Padova, 35128

  • Universita degli Studi di Torino

    Torino, 10122

Other trials in Italy

United Kingdom5 sites

  • Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street

    Bristol, BS1 2LX

  • Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology

    Camberley, GU16 7UJ

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Macular Unit, Hospital of St Cross

    Rugby, CV22 5PX

  • Royal Hallamshire Hospital, Eye Department

    Sheffield, S10 2JF

Other trials in United Kingdom

Australia2 sites

  • Center for Eye Research Australia

    Melbourne, Victoria, 3002

  • Lions Eye Institute, University of Western Australia

    Nedlands, 6009

Other trials in Australia

France2 sites

  • Service d'Ophtalmologie

    Bordeaux, 33076

  • "Centre Hospitalier Intercommunal de Creteil "

    Créteil, 94000

Other trials in France

Germany2 sites

  • "Universitat Bonn, Abteilung fur Augenheilkunde "

    Bonn, 53127

  • STZ Eyetrial

    Tübingen, 72076

Other trials in Germany

About this study

Official title: 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.

Being tested
400 µg Brimonidine Implant, Sham
Medical subject headings
Geographic Atrophy, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 400 µg Brimonidine ImplantDrug

    Also called AGN-190342

    400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.

  • ShamOther

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

Study groups in NCT02087085
Study groupRoleWhat they receive
400 µg Brimonidine ImplantExperimental400 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.
Receives: Drug: 400 µg Brimonidine Implant
ShamSham 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.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1) to Month 24

Secondary outcomes (2)

  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

    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.

    Measured: Baseline (Day 1) to Month 24

  2. 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.

    Measured: Baseline (Day 1) to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2014 (estimated)
  2. Study start9 May 2014
  3. Primary completion30 Mar 2018
  4. Study completion30 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02087085
Sponsor's protocol ID
190342-038
Other IDs
2013-003320-36
Acronym
BEACON
Status last verified
Mar 2019
First submitted
12 Mar 2014
Last updated
23 Apr 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 33383315

  • 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.

    PubMed 32134802

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 400 µg Brimonidine Implant in people with Geographic Atrophy and Macular Degeneration, run by Allergan at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Italy, United Kingdom, Australia, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02087085, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2019.

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