The Rocc-study: A Randomized Study Comparing the Safty and Efficacy of Ranibizumab (lucentis®) to Sham in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion (crvo)

Abstract

Purpose: : The purpose of this placebo controlled study is to evaluate the efficacy and safety of treatment with ranibizumab in patients with macular edema following central retinal vein occlusion.

Methods: : A total of 20 of the expected 32 patients are currently enrolled in this 6 month follow-up multi-center study. They have received 3 monthly intravitreal injections of 0,5 mg ranibizumab or sham treatment, which was conducted by pressing a glass vial against the bulb. Retreatment was given at the discretion of the physician during the remainder of the study. The primary objective is to compare the efficacy and safety of ranibizumab in the treatment of macular edema following central retinal vein occlusion with respect to visual acuity (ETDRS letters) and macular thickness. Secondary objectives are to evaluate the safety and tolerability of ranibizumab in eyes with CRVO, to evaluate the number of treatments needed, and to evaluate the development of neovascularizations.

Results: : This interim analysis reveals that 20 patients with a mean age of 72 years have been included in the study so far. Among these patients the mean BCVA at baseline was 39 ETDRS-letters, with a corresponding mean macular thickness of 602 µm. At present 3 patients have completed the study and they have by change all belonged to the treatment group. After the 3 first obligatory injections, the mean macular thickness decreased from 706 µm to 187 µm, whereas the mean BCVA remained relatively stable at 41 letters.

Conclusions: : The interim analysis reveals that among the patients who have completed the study so far, ranibizumab tends decreases macular edema, whereas the effect on VA varies. More extensive analysis will be presented when the study is completed.

Clinical Trial: : www.clinicaltrials.gov NCT00567697

Keywords: vascular occlusion/vascular occlusive disease • edema • vascular endothelial growth factor