Session Title: Free Paper Session 4: AMD II
Session Date/Time: Thursday 07/09/2017 | 11:00-12:30
Paper Time: 11:00
Venue: Room 111
First Author: : S.Thiele GERMANY
Co Author(s): : F. Ziemssen G. Spital S. Schmitz-Valckenberg J. Voegeler M. Koch S. Liakopoulos
Neovascular age-related macular degeneration (nAMD) limits patients in a wide range of activities and thus influences their every-day life. Treatment with ranibizumab, an anti-vascular endothelial growth factor (VEGF), has already demonstrated a beneficial effect on nAMD and gains in visual acuity (VA) of nAMD patients. However, VA improvement may not allow for any conclusions on the patients’ perception of his or her quality of life (QOL). Thus, to allow for a better understanding, one aspect of the prospective non-interventional OCEAN trial (NCT02194803) was to measure QOL of nAMD patients under real-life conditions.
Treatment patterns under real-life conditions were monitored in this multicentre, prospective, non-interventional study in accordance with the tenets of the Declaration of Helsinki. Examinations and treatments were performed according to the routine praxis management. To reflect the real world approach, there was no mandated treatment frequency per protocol.
In the OCEAN study, 3.630 patients with nAMD were enrolled and observed over 24 months. The 12-month pre-planned interim-analysis evaluated the number of visits and ranibizumab injections, change in best-corrected VA (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] letters), use of diagnostic tools like SD-OCT, occurrence of adverse events, concomitant medications, and QOL evaluated with visual function questionnaire-25 (VFQ-25).
nAMD patients had a baseline visual acuity of 52.0 ± 21.3 (±SD) ETDRS letters. At the end of the first year the mean BCVA was 55.8 ± 23.4 ETDRS letters. 3076 patients completed the VFQ-25 questioner. The VFQ-25 general vision subscale score increased from 58.0 ± 17.9 (baseline) to 62.9 ± 17.2 (month 4) and generally maintained this improvement to month 12 (62.9 ± 17.9). In the general health subscale score, patients improved from baseline score of 44.7 ± 19 to 46.2 ± 18.5 at month 4 and 45.7 ± 19.1 at month 12. Younger patients (<70 years) showed a higher increase from their baseline score of 50.3 ± 20.7 to 52.5 ± 20.1 (month 4) and 54.2 ± 20.7 (month 12). Further, patients also improved their near vision score (+3.1 after 4 months) and distance vision score (+1.7 VFQ after 4 months) slightly compared to baseline, but their values for social function, mental health and driving deteriorated somewhat from baseline. There was no clear association between the improvement in visual acuity and the composite score of VFQ-25. No new safety signals for ranibizumab were identified. An update of the 24-month data will be presented.
Patients with nAMD enrolled in the OCEAN trial showed that their QOL with regard to general vision as well as near and distance vision, improved after already 4 months of treatment, however social function, mental health and the ability to drive a car deteriorated. The function of fellow eyes might have further attenuated a significant change in the mentioned values describing the patients' QOL. The evaluation of VFQ-25 is important to understand the patients’ needs and further improve and optimize patient care in order to achieve a better QOL for patients with nAMD.