Purpose: The study aimed to investigate visual function outcome over 12 months after starting aflibercept treatment for diabetic macular edema (DME) using a novel protocol, in which the loading phase involved administration until edema improvement and the maintenance phase involved administration every 2 months.
Methods: The subjects comprised 49 DME patients with central macular thickness (CMT) in the eyes of ≥ 400 μm, best corrected visual acuity of 0.15-1.0 logMAR, and untreated macular edema. During the loading phase, intravitreal injections of aflibercept were administered every month until CMT of <300 μm was achieved (maximum: 6 times), followed by bi-monthly injections during the maintenance phase. The evaluation parameters were as follows: the degree of visual acuity improvement at 12 months after initiating administration, percentage of cases with change of ≥ 0.3 logMAR for visual acuity improvement, number of cases by aflibercept administration frequency during the loading phase, and mean number of doses over 12 months.
Results: This treatment protocol resulted in mean visual acuity improvement over 12 months of 0.17±0.24 logMAR (approx. 8.5 letters), improvement of ≥ 0.3 logMAR (15 letters) for 30.6% (15 cases), and deterioration in 4.1% (2 cases). CMT of <300 μm was achieved with one dose during the loading phase for 18 cases (36.7%), while 6 continuous doses were required for 7 cases (14.3%). The total number of doses over 12 months was 7.14±1.08.
Conclusions: Our results demonstrated that this novel treatment protocol involving the administration of aflibercept, as required, during the loading phase and then the implementation of bi-monthly injections during the maintenance phrase was effective for improving visual acuity in DME patients.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 124: 794-801, 2020.