This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
668
700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.
350 µg Dexamethasone intravitreal implant administered on Day 0.
Sham injection on Day 0.
Unnamed facility
Houston, Texas, United States
Unnamed facility
São Paulo, Brazil
Unnamed facility
Mississauga, Ontario, Canada
Unnamed facility
Bogotá, Colombia
Number of Patients With 15 or More Letter Improvement 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). 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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.
Time frame: Day 180
Change From Baseline in Retinal Thickness in the Study Eye
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time frame: Baseline, Day 90, Day 180
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
Time frame: Baseline, Day 90
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening.
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Unnamed facility
Kowloon, Hong Kong
Unnamed facility
Tamil Nadu, India
Unnamed facility
Udine, Italy
Unnamed facility
Auckland, New Zealand
Unnamed facility
Poznan, Poland
Unnamed facility
Singapore, Singapore
...and 3 more locations
Time frame: Baseline, Day 180