Efficacy of intravitreal AFlibercept injection For Improvement of retinal Nonperfusion In diabeTic retinopathY (AFFINITY study).

Introduction To evaluate the effects of intravitreal aflibercept injection on retinal nonperfusion in patients with diabetic retinopathy (DR) using ultrawide field (UWF) fluorescein angiography (FA). Research design and methods Thirty-eight eyes of 38 consecutive patients with DR and substantial retinal nonperfusion (nonperfusion index (NPI): nonperfused/total gradable area >0.2) without macular edema were included in this prospective case series. Monthly injections of 2 mg aflibercept were given for 6 months. UWF-fundus photography and UWF-FA images were acquired at baseline, 6 months, and 12 months and evaluated by 2 masked, independent graders for the extent of retinal nonperfusion and vascular leakage. Twenty untreated fellow eyes were analyzed as controls. Results Inter-grader agreement was strong (r=0.875) for NPI measurements. NPI was 0.46±0.10 at baseline; NPI was decreased to 0.43±0.08 (p=0.015) after 6 monthly injections of aflibercept and then slightly increased to 0.44±0.09 (p=0.123) after 6 months of observation. Vascular leakage also significantly decreased by 21.0% at 6 months (p=0.010). Untreated fellow eyes did not show significant changes in NPI and vascular leakage during follow-up. Reduction in retinal nonperfusion was associated with severe nonproliferative diabetic retinopathy (NPDR) (vs PDR, OR 19.119, p=0.025) and higher leakage index (per 0.1, OR 15.152, p=0.020). Conclusions Intensive aflibercept treatment was effective in reducing retinal capillary nonperfusion in patients with DR without macular edema. Severe NPDR and profound vascular leakage were significantly associated with retinal reperfusion after aflibercept treatment. Trial registration number NCT03006081.