This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
307
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Unnamed facility
Paris, France
Unnamed facility
Munich, Germany
Unnamed facility
Tel Aviv, Israel
Unnamed facility
Milan, Italy
Unnamed facility
Madrid, Spain
Change From Baseline in Best Corrected Visual Acuity (BCVA)
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.
Time frame: Baseline, Month 12
Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)
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 12. A negative change from Baseline indicates improvement.
Time frame: Baseline, Month 12
Percentage of Patients With 15-or-More Letter Improvement in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Time frame: Baseline, Month 12
Percentage of Patients With a 15-or-More Letter Decrease in BCVA
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).
Time frame: Baseline, Month 12
Time to BCVA Improvement of 15-or-More Letters
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Unnamed facility
London, United Kingdom
BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.
Time frame: 12 Months
Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)
The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.
Time frame: Baseline, Month 12
Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure
Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.
Time frame: 12 Months