Influence of OCT-examination during ranibizumab treatment of AMD patients in a real-life setting (OCEAN study)

Abstract

Purpose : Randomized controlled trials have proven the beneficial effect of vascular endothelial growth factor (VEGF) inhibition with ranibizumab in neovascular age-related macular degeneration (nAMD). The non-interventional, prospective OCEAN trial (NCT02194803) was initiated to evaluate ranibizumab treatment patterns in real-life conditions and to allow for a better understanding of challenges. The study evaluated the impact and use of optical coherence tomography (OCT) imaging, the key monitoring tool to guide retreatment in nAMD, which was newly implemented in local guidelines at the beginning of the observational period.

Methods : 5.779 patients are observed in a prospective manner over 24 months. The 12-month interim-analysis evaluated the number of visits, visual acuity, number of injections, the use of diagnostic tools and adverse events of 3.630 patients diagnosed with nAMD (61% female/39% male) with an average age of 77.9 years.

Results : The mean baseline BCVA was 52.0 ETDRS letters. During the first year, patients received an average of 4.5 injections and gained 3.8 respectively 4.2 letters (by injecting ophthalmologists) after 12 months (55.8 ± 23.4 ETDRS letter). 37.9% of patients gained ≥ 5 letters, while 21.1% even gained ≥ 15 letters.
The average time between the first visual acuity assessment and the first ranibizumab treatment was 22.4 days. A subgroup of patients treated with a delay of less than 14 days showed notably higher BCVA gains.
Patients underwent 9.5 BCVA assessments and 4.0 OCT examinations. When OCT imaging was performed at ≥ 4 visits, a higher number of patients achieved ≥ 10 letters (31.1%) compared with patients receiving only one or none OCTs (23.1%). The proportion of patients discontinuing the trial does not show any correlation to patient’s baseline VA. No new safety signals were identified.
An update of 24-month data will be presented.

Conclusions : This interim analysis of the non-interventional OCEAN trial shows a beneficial effect of ranibizumab after 12 months for nAMD patients when observed in a real-life setting. The presented data implies that there might be an association of improvement of VA and number of OCT-examinations. Our data show that better VA gain can be achieved with a higher number of visits using OCT scans for (re-)treatment decisions in a real-life setting.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.