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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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).
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 - 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).
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 - BCVA is measured using an eye chart and is 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). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Timepoint [2] 0 0
Baseline, 24 Months
Secondary outcome [3] 0 0
Change From Baseline in Contrast Sensitivity in the Study Eye - Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.
Timepoint [3] 0 0
Baseline, 24 Months
Secondary outcome [4] 0 0
Change From Baseline in Reading Speed in the Study Eye - Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/NCT00658619
Trial related presentations / publications
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
Other publications