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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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)
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Scientific title
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
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Secondary ID [1]
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190342-032D
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, Month 12
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Secondary outcome [1]
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Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
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Assessment method [1]
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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).
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Timepoint [1]
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Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
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Secondary outcome [2]
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Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline, 24 Months
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Secondary outcome [3]
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Change From Baseline in Contrast Sensitivity in the Study Eye
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline, 24 Months
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Secondary outcome [4]
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Change From Baseline in Reading Speed in the Study Eye
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, 24 Months
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Eligibility
Key inclusion criteria
- Geographic atrophy in both eyes due to age-related macular degeneration
- Visual acuity between 20/40 to 20/320
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/04/2011
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Sample size
Target
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Accrual to date
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Final
119
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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- Sydney
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Recruitment postcode(s) [1]
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- Sydney
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Texas
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Country [2]
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Germany
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State/province [2]
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Karlsruhe
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Country [3]
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Italy
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State/province [3]
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Udine
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Country [4]
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Korea, Republic of
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State/province [4]
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Seoul
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Country [5]
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Philippines
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State/province [5]
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Makati City
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Country [6]
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Portugal
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State/province [6]
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Coimbra
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00658619
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Allergan
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00658619
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