Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
1 other identifier
interventional
119
7 countries
7
Brief Summary
Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2008
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
April 15, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2011
CompletedResults Posted
Study results publicly available
April 26, 2013
CompletedAugust 21, 2018
July 1, 2018
2.1 years
April 11, 2008
March 13, 2013
July 24, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm\^2).
Baseline, Month 12
Secondary Outcomes (4)
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Baseline, 24 Months
Change From Baseline in Contrast Sensitivity in the Study Eye
Baseline, 24 Months
Change From Baseline in Reading Speed in the Study Eye
Baseline, 24 Months
Study Arms (5)
400 µg Brimonidine Tartrate Implant Stage 1
OTHERStage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 1
OTHERStage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
400 µg Brimonidine Tartrate Implant Stage 2
OTHERStage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
200 µg Brimonidine Tartrate Implant Stage 2
OTHERStage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.
Sham (no implant) Stage 2
SHAM COMPARATORStage 2: sham in both eyes on Day 1 and Month 6.
Interventions
400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
Sham in one or both eyes on Day 1 and Month 6.
Eligibility Criteria
You may qualify if:
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
You may not qualify if:
- Known allergy to brimonidine
- Uncontrolled systemic disease or infection of the eye
- Recent eye surgery or injections in the eye
- Female patients who are pregnant, nursing or planning a pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (7)
Unknown Facility
Abilene, Texas, United States
Unknown Facility
Sydney, New South Wales, Australia
Unknown Facility
Karlsruhe, Germany
Unknown Facility
Udine, Italy
Unknown Facility
Makati City, Philippines
Unknown Facility
Coimbra, Portugal
Unknown Facility
Seoul, South Korea
Related Publications (1)
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.
PMID: 32134802DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2008
First Posted
April 15, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2010
Study Completion
April 8, 2011
Last Updated
August 21, 2018
Results First Posted
April 26, 2013
Record last verified: 2018-07