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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
119
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.
Unnamed facility
Abilene, Texas, United States
Unnamed facility
Sydney, New South Wales, Australia
Unnamed facility
Karlsruhe, Germany
Unnamed facility
Udine, Italy
Unnamed facility
Makati City, Philippines
Unnamed facility
Coimbra, Portugal
Unnamed facility
Seoul, South Korea
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).
Time frame: Baseline, Month 12
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).
Time frame: Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
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.
Time frame: Baseline, 24 Months
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.
Time frame: Baseline, 24 Months
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.
Time frame: Baseline, 24 Months
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