Real-world visual outcomes at 24 weeks in patients with diabetic macular edema receiving aflibercept intravitreal injections as per UK license.

Abstract

Purpose : The European license of aflibercept for center-involving diabetic macular edema (DME) is based on the VIVID and VISTA clinical trials. In the UK, NICE does not routinely fund this treatment unless central macular thickness (CMT) is >400 µm. We wished to identify outcomes for patients in a UK real-world setting compared with seminal phase III clinical trials.

Methods : We performed a prospective, dual-center observational study of all anti-VEGF treatment-naïve eyes receiving aflibercept for at least 24 weeks at the Royal Free London NHS Foundation Trust (RFLNFT). Fight Retinal Blindness! software was used to record real-world outcomes including distance visual acuity (VA) and central subfield thickness (CST). P-values were obtained using paired t-tests.

Results : There were 33 eyes from 27 patients. The mean (SD) VA at the first injection was 64.1 (9.3) LogMAR letters. At 24 weeks, after a median of 5 (range 3-6) injections, the mean (SD) VA was 67.4 (9.1) letters, an increase of 3.3 (95% CI: -0.4, 7.0; P = 0.08) letters. The percentage of eyes gaining 15 letters was 18% (6 eyes) and losing 15 letters was 3% (1 eye). The mean (SD) CST at the first injection was 416 (79) µm. At 24 weeks, this reduced to 290 (86) µm, a decrease of 126 (95% CI: -167, -85; P<0.001) µm. Twelve eyes had previous macular laser. Compared with the VIVID and VISTA clinical trials, baseline VA and CST was better in our cohort (Table 1).

The percentage of eyes with legal driving vision (≥70 letters) was 53% when CST was first >300 µm, 36% (12 eyes) at time of first injection and 45% (15 eyes) after 24 weeks. The median (Q1,Q3) delay between CST >300 µm and first injection of aflibercept as per NICE guidance was 328 days (57,629) days. This delay was associated with a mean VA loss of 5.6 (95% CI: -9.3, -1.8; P=0.005) letters.

Conclusions : Patients in the real-world receiving aflibercept for DME as per NICE guidance can achieve some visual improvement after 24 weeks. The visual and anatomical improvement was not as great as the VIVID and VISTA trials. This likely relates to less room for improvement due to better baseline VA and CST in our cohort. Delay in initiating treatment from diagnosis of center-involving DME >300 µm until CMT >400 µm was associated with significant visual morbidity.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Table 1: Baseline and mean change at 24 weeks for visual acuity and central subfield thickness.