A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.
Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.
Bettina Kinge, Retinaklinikken Aleris
Oslo, Norway
Ingar Stene Johansen
Oslo, Norway
Vegard Forsaa
Stavanger, Norway
Kristian Fossen
Tromsø, Norway
The primary efficacy outcome measure is the mean change from baseline in BCVA score
Time frame: 6 months
Mean change from baseline in BCVA score, central foveal thickness and in the NEI VFQ-25 near activities subscale.
Time frame: 6 months
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