Real-World Outcomes of Aflibercept Treatment for Diabetic Macular Edema

Author: Urte Skirmantaite (Lithuania)

Co-authors: Vilma Jurate Balciuniene, Aiste Varoniukaite, Tadas Naujokaitis

Purpose

Intravitreal injections of vascular endothelial growth factor inhibitors, one of which is aflibercept, have replaced macular laser photocoagulation as the mainstay treatment for diabetic macular edema (DME). Although clinical trials have demonstrated the effectiveness of aflibercept treatment, the outcomes may differ in a real-world clinical setting. The aim of this study was to evaluate the outcomes of aflibercept treatment for DME in a real-world clinical setting.

Setting/Venue

The study took place at the Hospital of Lithuanian university of health sciences Kauno klinikos department of Ophthalmology.

Methods

This retrospective monocenter study involved the analysis of medical records of patients who started aflibercept treatment for DME at the Hospital of the Lithuanian University of Health Sciences Kauno klinikos between October 2017 and November 2019. Anonymized data regarding follow-up visits, aflibercept injections administered and best-corrected visual acuity (BCVA) were collected. Snellen BCVA measurements were converted to approximate Early Treatment Diabetic Retinopathy Study letter scores. The Wilcoxon signed rank test was used to compare BCVA values at baseline with values at different time points during the follow-up period. Baseline BCVA subgroups were compared using the Kruskal-Wallis test. P value <0.05 was considered statistically significant.

Results

89 eyes of 68 patients were included in the study. The median follow-up duration was 469 days (min 276; max 764). Over the first year, all eyes received a median of 5 injections (min 1; max 9). Among eyes with at least 24 months of follow-up and ≥1 injection over the second year, a median of 3 injections (min 1; max 6) were administered over the second year of the treatment. 87.6 % of eyes were treatment-naive prior to the study while 12.4 % of eyes had been previously treated with laser photocoagulation. The median baseline BCVA was 82 letters (min 30; max 100). BCVA improved by a median of 3 letters 365 ± 60 days and 730 ± 60 days after baseline. At the first visit ≥365 days after baseline, 9.2 % of eyes gained ≥15 letters from baseline while 10.1 % of eyes lost ≥15 letters. For 67.4% of eyes, BCVA improved (gain of ≥5 letters) or remained stable (gain/loss of ≤4 letters). Although the changes in BCVA were less noticeable among eyes with better baseline BCVA (>68 letters), their BCVA remained better than of eyes with worse baseline BCVA throughout the two years of follow-up (p<0,001).

Conlusions

Injections were administered less frequently than in randomized prospective clinical trials. BCVA outcomes were also inferior to those reported in clinical trials. The improvement in BCVA was maintained throughout a year of follow-up. Among eyes with worse baseline BCVA, the change in BCVA was more noticeable but not sufficient to reach the BCVA of eyes with better baseline BCVA.

Financial Disclosure

We have no financial relations with any company.