Clinical trial NCT02087085: A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
Official title: Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Geographic Atrophy
Macular Degeneration
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-03-14
Enrollment: 310
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Geographic Atrophy (GA) Lesion Area of the Study Eye as Assessed by Fundus Autofluorescence (FAF) at Month 24
timeFrame: Baseline (Day 1) to Month 24
Secondary outcomes:
measure: Change From Baseline in Standard Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at Month 24
timeFrame: Baseline (Day 1) to Month 24
measure: Change From Baseline in Low Luminance BCVA Score as Assessed by ETDRS Chart at Month 24
timeFrame: Baseline (Day 1) to Month 24
Other outcomes:
measure: Change From Baseline in Retinal Sensitivity in the Study Eye
timeFrame: Baseline (Day 1) to Month 24
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona, Ltd., Retinal Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego, Jacobs Retina Center, Shiley Eye Center
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado, PC
state: Colorado
city: Fort Myers
country: United States
facility: "National Ophthalmic Research Institute Retina Consultants of Southwest Florida"
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates, PL
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Decatur
country: United States
facility: Georgia Retina
state: Georgia
city: Indianapolis
country: United States
facility: Raj K. Maturi, MD
state: Indiana
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Associates, PA
state: North Carolina
city: Eugene
country: United States
facility: Oregon Retina, LLP
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute, Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina, Wills Eye Retina Surgeons
state: Pennsylvania
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: "Austin Retina Associates "
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Melbourne
country: Australia
facility: Center for Eye Research Australia
state: Victoria
city: Nedlands
country: Australia
facility: Lions Eye Institute, University of Western Australia
city: Bordeaux
country: France
facility: Service d'Ophtalmologie
city: Creteil
country: France
facility: "Centre Hospitalier Intercommunal de Creteil "
city: Bonn
country: Germany
facility: "Universitat Bonn, Abteilung fur Augenheilkunde "
city: Tübingen
country: Germany
facility: STZ Eyetrial
city: Bologna
country: Italy
facility: Università di Cagliari (presidio San Giovanni di Dio)
city: Cagliari
country: Italy
facility: Università di Cagliari (presidio San Giovanni di Dio)
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milano
country: Italy
facility: Dir IV Clinica Oculistica di Milano, Ospedale Generale "Luigi Sacco" 
city: Padova
country: Italy
facility: Universita degli Studi di Padova, Dipartimento di Neuroscienze
city: Torino
country: Italy
facility: Universita degli Studi di Torino
city: Bristol
country: United Kingdom
facility: Clinical Research Unit, Level2, Bristol Eye Hospital, Lower Maudlin Street
city: Camberley
country: United Kingdom
facility: Frimley Park Hospital, Eye clinical trials Unit, Department of Opthalmology
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: Rugby
country: United Kingdom
facility: Macular Unit, Hospital of St Cross
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital, Eye Department
Study officials:
affiliation: Allergan
name: Claire Winterson
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.