The aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to BRVO if the re-treatment regimen is guided by morphological macular changes detected by OCT compared to re-treatment according to SmPC defined re-treatment criteria (in case of increase of CRT and concomitant decrease of BCVA).
In a prospective, randomized, interventional, controlled phase IIb clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by OCT compared to standard re-treatment criteria according to SmPC
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
comparison of different re-treatment criteria for intravitreal injection of ranibizumab
Department of Ophthalmology, University Leipzig
Leipzig, Germany
change of best corrected visual acuity (BCVA) measured in ETDRS letters
Time frame: 12 months
Central retinal thickness (CRT)
Time frame: 12 months
Number of applied ranibizumab injections
Time frame: 12 months
• Rates of patients developing a neovascularisation of the retina/ anterior segment
Time frame: 12 months
Assessment of safety: serious adverse events/ reactions; AEs/ARs
Time frame: 12 months
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