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

Macular Degeneration Clinical Trial

— BEACON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02087085
• Other study ID #: 190342-038
• Secondary ID: 2013-003320-36
• Status: Terminated
• Phase: Phase 2
• Start date: May 9, 2014
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 310
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
Australia	Center for Eye Research Australia	Melbourne	Victoria
Australia	Lions Eye Institute, University of Western Australia	Nedlands
France	Service d'Ophtalmologie	Bordeaux
France	"Centre Hospitalier Intercommunal de Creteil "	Creteil
Germany	"Universitat Bonn, Abteilung fur Augenheilkunde "	Bonn
Germany	STZ Eyetrial	Tübingen
Italy	Università di Cagliari (presidio San Giovanni di Dio)	Bologna
Italy	Università di Cagliari (presidio San Giovanni di Dio)	Cagliari
Italy	"Dir IV Clinica Oculistica di Milano, Ospedale Generale ""Luigi Sacco"" "	Milano
Italy	Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Ospedale San Raffaele	Milano
Italy	Universita degli Studi di Padova, Dipartimento di Neuroscienze	Padova
Italy	Universita degli Studi di Torino	Torino
United Kingdom	Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street	Bristol
United Kingdom	Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology	Camberley
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Macular Unit, Hospital of St Cross	Rugby
United Kingdom	Royal Hallamshire Hospital, Eye Department	Sheffield
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Texas Retina Associates	Arlington	Texas
United States	"Austin Retina Associates "	Austin	Texas
United States	Charlotte Eye Ear Nose & Throat Associates, PA	Charlotte	North Carolina
United States	Retina Consultants of Southern Colorado, PC	Colorado Springs	Colorado
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Georgia Retina	Decatur	Georgia
United States	Oregon Retina, LLP	Eugene	Oregon
United States	"National Ophthalmic Research Institute Retina Consultants of Southwest Florida"	Fort Myers	Florida
United States	Raj K. Maturi, MD	Indianapolis	Indiana
United States	University of California, San Diego, Jacobs Retina Center, Shiley Eye Center	La Jolla	California
United States	Valley Retina Institute	McAllen	Texas
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Retina Specialty Institute	Pensacola	Florida
United States	Mid Atlantic Retina, Wills Eye Retina Surgeons	Philadelphia	Pennsylvania
United States	Associated Retina Consultants	Phoenix	Arizona
United States	Retinal Consultants of Arizona, Ltd., Retinal Research Institute	Phoenix	Arizona
United States	Casey Eye Institute, Oregon Health and Science University	Portland	Oregon
United States	Retina Associates of Western New York	Rochester	New York
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Southern Vitreoretinal Associates, PL	Tallahassee	Florida
United States	Strategic Clinical Research Group, LLC	Willow Park	Texas
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Retinal Sensitivity in the Study Eye		Baseline (Day 1) to Month 24
Primary	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.	Baseline (Day 1) to Month 24
Secondary	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.	Baseline (Day 1) to Month 24
Secondary	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.	Baseline (Day 1) to Month 24

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