A study analyzed intravitreal aflibercept treatment and its impact on diabetic retinopathy severity in visual function in patients with proliferative diabetic retinopathy (PDR) who did not have diabetic macular edema (DME).
A total of 40 patients with PDR without DME were randomized to receive aflibercept 2 mg injections either monthly or quarterly and treated for a 12-month period. An Optos 200Tx device was used to perform ultra-wide field fundus imaging on patients, which included pseudocolor and fluorescein angiography. Certified reading center graders used the diabetic retinopathy severity scale (DRSS) to assess retinopathy severity at baseline and at six and 12 months; the baseline and 12-month DRSS scores were correlated with the 25- and 39-item Visual Function Questionnaire (VFQ) scores.
The mean patient age was 48.2 years (range, 25-75 years) and diabetes duration was 16.1 years (range, 2-36 years); mean hemoglobin A1C was 8.8%. From baseline to month 12, both the monthly and quarterly aflibercept groups experienced significant DRSS regression (P<0.001). At six-month follow-up, regression in the monthly group was significantly greater than that of the quarterly group (P=0.019), but by 12-month follow-up, the between-group difference was no longer statistically significant (P=0.309). After 12 months, there were no significant between-group differences in mean VFQ-25 (P=0.947) and VFQ-39 (P=0.921) composite scores. Twelve-month improvements in mean VFQ-25 and VFQ-39 composite scores were significantly associated with DRSS improvement (R=0.384, P=0.039; and R=0.361, P=0.046, respectively).
“In this study of eyes with PDR without DME, both monthly and quarterly aflibercept injection groups showed significant improvement in diabetic retinopathy severity at month 12 compared with baseline. The improvement in DRSS was associated with an improvement in VFQ composite score,” the study authors summarized.