The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
laser photocoagulation to the retina at the area of edema
RABAMES investigational trial site
Freiburg im Breisgau, Germany
RABAMES investigational trial site
Göttingen, Germany
RABAMES investigational trial site
Ludwigshafen, Germany
RABAMES investigational trial site
Mainz, Germany
Changes in best spectacle-corrected visual acuity (BSCVA)
Time frame: from baseline to month 6
Mean change in BSCVA
Time frame: from baseline to month 3
Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA
Time frame: from baseline to month 3 and 6
Proportion of patients who lose less than 15 letters of BCVA
Time frame: from baseline to month 3 and 6
Change in area and intensity of leakage
Time frame: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time frame: from baseline to month 1, 3 and 6
Mean change in central macular thickness (by OCT)
Time frame: from month 3 to 6
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