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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Secondary ID [1] 0 0
2013-003320-36
Secondary ID [2] 0 0
190342-038
Universal Trial Number (UTN)
Trial acronym
BEACON
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Geographic Atrophy 0 0
Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
Timepoint [1] 0 0
Baseline (Day 1) to Month 24
Secondary outcome [1] 0 0
Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
Timepoint [1] 0 0
Baseline (Day 1) to Month 24
Secondary outcome [2] 0 0
Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
Timepoint [2] 0 0
Baseline (Day 1) to Month 24

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.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2018
Sample size
Target
Accrual to date
Final
310
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Center for Eye Research Australia - Melbourne
Recruitment hospital [2] 0 0
Lions Eye Institute, University of Western Australia - Nedlands
Recruitment postcode(s) [1] 0 0
3002 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
France
State/province [12] 0 0
Bordeaux
Country [13] 0 0
France
State/province [13] 0 0
Creteil
Country [14] 0 0
Germany
State/province [14] 0 0
Bonn
Country [15] 0 0
Germany
State/province [15] 0 0
Tübingen
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Cagliari
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Padova
Country [20] 0 0
Italy
State/province [20] 0 0
Torino
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Bristol
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Camberley
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Rugby
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Claire Winterson
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02087085