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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00658619




Registration number
NCT00658619
Ethics application status
Date submitted
11/04/2008
Date registered
15/04/2008
Date last updated
21/08/2018

Titles & IDs
Public title
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Scientific title
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Secondary ID [1] 0 0
190342-032D
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 Tartrate Implant
Treatment: Drugs - 200 µg Brimonidine Tartrate Implant
Other interventions - Sham (no implant)

Other: 400 µg Brimonidine Tartrate Implant Stage 1 - Stage 1: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Other: 200 µg Brimonidine Tartrate Implant Stage 1 - Stage 1: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Other: 400 µg Brimonidine Tartrate Implant Stage 2 - Stage 2: 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Other: 200 µg Brimonidine Tartrate Implant Stage 2 - Stage 2: 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1 and Month 6.

Sham comparator: Sham (no implant) Stage 2 - Stage 2: sham in both eyes on Day 1 and Month 6.


Treatment: Drugs: 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.

Treatment: Drugs: 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.

Other interventions: Sham (no implant)
Sham in one or both eyes on Day 1 and Month 6.
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 Size of Geographic Atrophy Lesion Area in the Study Eye
Timepoint [1] 0 0
Baseline, Month 12
Secondary outcome [1] 0 0
Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Timepoint [1] 0 0
Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
Secondary outcome [2] 0 0
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Timepoint [2] 0 0
Baseline, 24 Months
Secondary outcome [3] 0 0
Change From Baseline in Contrast Sensitivity in the Study Eye
Timepoint [3] 0 0
Baseline, 24 Months
Secondary outcome [4] 0 0
Change From Baseline in Reading Speed in the Study Eye
Timepoint [4] 0 0
Baseline, 24 Months

Eligibility
Key inclusion criteria
* Geographic atrophy in both eyes due to age-related macular degeneration
* Visual acuity between 20/40 to 20/320
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/04/2011
Sample size
Target
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Germany
State/province [2] 0 0
Karlsruhe
Country [3] 0 0
Italy
State/province [3] 0 0
Udine
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seoul
Country [5] 0 0
Philippines
State/province [5] 0 0
Makati City
Country [6] 0 0
Portugal
State/province [6] 0 0
Coimbra

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00658619
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00658619