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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02087085
Registration number
NCT02087085
Ethics application status
Date submitted
12/03/2014
Date registered
14/03/2014
Date last updated
23/04/2019
Titles & IDs
Public title
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
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Scientific title
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
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Secondary ID [1]
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2013-003320-36
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Secondary ID [2]
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190342-038
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Universal Trial Number (UTN)
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Trial acronym
BEACON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy
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Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 400 µg Brimonidine Implant
Other interventions - Sham
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.
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.
Treatment: Drugs: 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 interventions: Sham
Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) to Month 24
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Secondary outcome [1]
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Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) to Month 24
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Secondary outcome [2]
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Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline (Day 1) to Month 24
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Eligibility
Key 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.
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Minimum age
55
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/05/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/03/2018
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Sample size
Target
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Accrual to date
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Final
310
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Center for Eye Research Australia - Melbourne
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Recruitment hospital [2]
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Lions Eye Institute, University of Western Australia - Nedlands
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Recruitment postcode(s) [1]
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3002 - Melbourne
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Georgia
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Indiana
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New York
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North Carolina
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Oregon
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Pennsylvania
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Texas
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France
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Bordeaux
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France
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Creteil
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Germany
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Bonn
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Germany
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Tübingen
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Italy
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Bologna
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Italy
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Cagliari
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Italy
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Milano
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Italy
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Padova
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Italy
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Torino
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United Kingdom
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Bristol
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United Kingdom
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Camberley
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United Kingdom
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London
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United Kingdom
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Rugby
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02087085
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Claire Winterson
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Address
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Allergan
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02087085
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