The non-interventional OCEAN Study evaluated frequency and monitoring injections for retinal vein occlusion (RVO) in routine practice in Germany. The Novartis-sponsored real-world study revealed that patients with RVO in routine practice in Germany received fewer injections and fewer OCT examinations than in clinical trials.
What is RVO?
RVO is a blockage of the small veins that carry blood away from the retina. The retina is the layer of tissue at the back of the brain.
Involving 5,778 patients the sponsors led this multicenter, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to choroidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions reported DovePress.
Basel Switzerland-based Novartis
Overall, DovePress reported 744 overall RVO patients (27% BRVO, 16% CRVO, remaining unspecified RVO) were included. For 74% of patients, data were available for the 12-month visit and for 56% for the 24-month visit. Mean baseline BCVA was 52.0 Early Treatment for Diabetic Retinopathy Study (ETDRS) letters (BRVO: 55.9, CRVO: 43.9). BCRA improved rapidly within the first 3 months, reaching 64.3 letters at 12 months and 64.7 at 24 months. CRVO patients showed less improvement that those with BRVO. Patients received a median of 4 (5) injections over 12 (24) months, with 100% of patients demonstrating a ≥15 letter increase within the first 3 moths (42% BRVO, 46% CRVO). Patients with low initial BCVA (<50 letters) showed greater improvement than patients with higher baseline BCVA. Due to the considerable loss to follow-up, the number of injections and optical coherence tomography (OCT) examinations were not associated with changes in BCVA.
DovePress reported that patients with RVO in routine practice in Germany received fewer injections and fewer OCT examinations than in clinical trials. CRVO patients showed less and later improvement compared to BVRO patients.