[Delayed treatment initiation of more than 2 weeks. Relevance for possible gain of visual acuity after anti-VEGF therapy under real life conditions (interim analysis of the prospective OCEAN study)]

Abstract

Background: The largest German prospective non-interventional ophthalmological study OCEAN (NCT02194803) investigates the treatment of retinal diseases with ranibizumab in routine patient care. A feature of this study is the participation of ophthalmic surgeons in surgical centers as well as general ophthalmologists who do not perform intravitreal injections themselves.

Objectives: The functional outcome following administration of three intravitreal injections was analyzed with respect to the time from initial examination to the first injection (defined as treatment delay) as well as potentially confounding factors.

Material and methods: This interim analysis included only data from therapy naïve patients participating in the OCEAN study, who received at least three ranibizumab injections. The potential impact of various factors on treatment delay was analyzed by the χ(2)-test.

Results: Data of 1333 patients were analyzed. The median delay before treatment was 15 days (range 0-90 days). Patients with a delay of more than 28 days showed a significantly lower gain in visual acuity than patients with a delay of less than 14 days. Age, gender and baseline visual acuity did not show an association with the treatment delay; however, referral from a primary care ophthalmologist, undertaking fluorescein angiography in an external practice and the underlying indications did affect the observed treatment delays.

Conclusion: Every patient should be treated within 14 days, following recent recommendations of the ophthalmological societies. Liability issues have to be considered as the statistical evaluation of real life data showed unambiguous results.

Keywords: Intravitreal drug administration; Non-interventional study; Ranibizumab; Retinal diseases; Routine patient care.