The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
243
Intravitreal injection of dexamethasone 700 µg at Day 1.
Ranibizumab 500 µg at day -30 and Day 7-14.
Sham needle-less injection administered in the study eye at Day 1.
Unnamed facility
Boynton Beach, Florida, United States
Unnamed facility
Parramatta, New South Wales, Australia
Unnamed facility
Paris, France
Unnamed facility
Tel Aviv, Israel
Injection Free Interval
The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
Time frame: Week 1 to Week 25
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25
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). An increase in the number of letters read correctly means that vision has improved.
Time frame: Baseline, Week 25
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye
Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25.
Time frame: Baseline, Week 25
Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye
Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.
Time frame: Screening (-Week 28), Week 25
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Unnamed facility
Milan, Italy
Unnamed facility
Auckland, New Zealand
Unnamed facility
Coimbra, Portugal
Unnamed facility
Seoul, South Korea
Unnamed facility
Southampton, Hampshire, United Kingdom