This was a Phase III, multicenter, randomized, double-masked, sham injection-controlled study of the efficacy and safety of intravitreal ranibizumab compared with sham injections in patients with macular edema secondary to branch retinal vein occlusion (BRVO); 397 patients with BRVO were enrolled at 93 investigational sites in the United States. The study included a treatment period (6 months) and an observation period (6 months).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
397
Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Score at 6 Months
BCVA score in the study eye was based on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
Time frame: Baseline and 6 months
Percentage of Participants Who Gained ≥ 15 Letters in BCVA Score at Month 6 Compared With Baseline
BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters.
Time frame: Baseline and 6 months
Percentage of Participants Who Lost < 15 Letters in BCVA Score at Month 6 Compared With Baseline
BCVA score based on the ETDRS visual acuity charts (number of correct letters) and assessed at a starting distance of 4 meters. The percentage of subjects who lost \<15 letters will be greater than the percentage of subjects who "gained \>=15 letters" as "losing \<15 letters" includes both those who gained \>=15 letters and those who were "stable" (i.e. lost between 1 and 14 letters, had no change, or gained between 1 and 14 letters).
Time frame: Baseline and 6 months
Percentage of Participants With a Central Foveal Thickness of ≤ 250 μm at Month 6
A central reading center assessed all optical coherence tomography (OCT) images. Central foveal thickness was defined as the center point thickness.
Time frame: 6 months
Mean Absolute Change From Baseline in Central Foveal Thickness at Month 6
A central reading center assessed all OCT images. Central foveal thickness was defined as the center point thickness.
Time frame: Baseline and 6 months
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Near Activities Subscale Score at Month 6
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The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A3, A4, and A5 pertained to the Near Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
Time frame: Baseline and 6 months
Mean Change From Baseline in the NEI VFQ-25 Distance Activities Subscale Score at Month 6
The NEI VFQ-25 (v. 2000; Interviewer Format) consisted of the base set of 25 questions, plus the optional additional questions (where questions A6, A7, and A8 pertained to the Distance Activities Subscale). Scores ranged from 0 to 100; a higher score represented better functioning.
Time frame: Baseline and 6 months