OBJECTIVES:

To report the results for vision-related quality of life, as assessed by the Visual Functioning Questionnaire-25 (VFQ-25) in the KESTREL and KITE studies evaluating the safety and efficacy of brolucizumab 6mg vs aflibercept 2mg in diabetic macular edema (DME).

METHODS:

The questionnaire was completed at baseline and Weeks 28, 52, 76 and 100. The 11-vision-related VFQ-25 subscales are general vision, ocular pain, near and distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision and peripheral vision, with a composite score as the average of the 11 subscales. Change from baseline in subscale and composite scores by visit were analyzed using an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect factor and corresponding baseline value of the endpoint as a covariate.

RESULTS:

In the KESTREL study, improvements from baseline in the composite score were similar between brolucizumab vs aflibercept at Week 52 (7.1 vs 8.1, diff -1.0, 95%-CI [-3.4, 1.4] and at Week 100 (6.2 vs. 6.4, diff -0.2, 95%-CI [-2.9, 2.6]). The change from baseline in general vision was favorable in brolucizumab vs aflibercept at Week 52 (11.8 vs 10.2, diff 1.6, 95%-CI [-1.3, 4.5]). This was maintained through Week 100 (13.3 vs 11.7, diff 1.5, 95%-CI [-1.5, 4.5]). In the KITE study, improvements from baseline in the composite score were favorable in brolucizumab vs aflibercept arms at Week 52 (9.1 vs 6.5, diff 2.5, 95%-CI [0.2, 4.8]) and at Week 100 (9.3 vs 5.9, diff 3.4, 95%-CI [0.8, 6.1]). The same trend was observed in the general vision scores at Week 52 (11.7 vs 10.1, diff 1.6, 95%-CI [-1.6, 4.8]) and at Week 100 (12.4 vs 9.7, diff 2.7, 95%-CI [-0.6, 6.0]).

CONCLUSIONS:

Meaningful improvements in vision-related quality of life of DME patients were demonstrated in brolucizumab-treated patients and comparable to those treated with aflibercept.