Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study.

The non-interventional OCEAN study (NCT02194803) evaluated frequency and monitoring of ranibizumab injections for retinal vein occlusion (RVO) in routine practice in Germany. RVO patients (including branch and central RVO (BRVO/CRVO)) receiving ranibizumab were included. Best-corrected visual acuity (BCVA) testing, imaging and treatment were performed at the investigators' discretion and documented over 24 months. Overall, 744 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). BCVA 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 than those with BRVO. Patients received a median of 4 (5) injections over 12 (24) months, with 100% of patients receiving injections at baseline, 70% at Month 1 and 81% at Month 2. Overall, 40% of patients demonstrated a ≥15 letter increase within the first 3 months (42% BRVO, 46% CRVO). Patients with low initial BCVA (<50 letters) showed greater improvement than patients with higher baseline BCVA. Due to considerable loss to follow-up, the number of injections and optical coherence tomography (OCT) examinations were not associated with the change in BCVA. 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 BRVO patients.

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© 2019 Callizo et al.

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Josep Callizo received personal fees and research grants from Novartis and personal fees from Bayer Healthcare and Allergan. Focke Ziemssen received grants and personal fees from Biogen, Allergan, Alimera, Bayer Healthcare and Roche, grants from Clearside, personal fees from Boehringer Ingelheim, Novartis, NovoNordisk, MSD Sharp & Dohme. Thomas Bertelmann received research grants from Novartis, personal fees from Alcon, Alimera, Allergan, Bayer, Heidelberg, Novartis, and was a Medical Advisor for Novartis (2015–2016). Nicolas Feltgen has received funds from Novartis, Allergan, Bayer, Alimera, Heidelberg Engineering, and Roche. Jessica Voegeler and Mirja Koch are Novartis employees. Nicole Eter received research grants from Novartis and Bayer, speaker’s honorarium from Novartis, Bayer, Allergan, Heidelberg Engineering, and Alimera, and served on Advisory Boards for Novartis, Bayer, Allergan, Alimera, and Roche. Sandra Liakopoulos received speaker’s fees from Novartis, Carl Zeiss Meditec, Heidelberg Engineering, Allergan, Bayer; non-financial research support from Carl Zeiss Meditec and Heidelberg Engineering and was member of an advisory board for Novartis. Steffen Schmitz-Valckenberg received grants and non-financial research funding from Accucela, Alcon/Novartis, Allergan, Bayer, Bioeq/Formycon, Centervue, Genentech/Roche, Heidelberg Engineering, Optos, Carl Zeiss MediTec, and personal fees and honoraria from Alcon/Novartis, Bayer, Genentech/Roche, Carl Zeiss MediTec. Georg Spital received personal fees from Bayer Healthcare, Novartis, Carl Zeiss Meditec, OD-OS. The authors report no other conflicts of interest in this work.