Abstract
Purpose :
Anti-VEGFs are the current standard of care in managing patients with diabetic macular edema (DME). However, the most suitable regimen following loading doses remains unclear. We performed a multicenter, single-arm, open-label, prospective, interventional study to investigate the efficacy and safety of aflibercept in a treat-and-extend regimen for patients with DME.
Methods :
This phase IIIb/IV study was conducted in five centers in Taiwan. Forty five treatment-naïve DME patients were administered five monthly doses of intravitreal aflibercept (2.0 mg) followed by a treat-and-extend (T&E) regimen with a 4-week interval increment/decrement with the maxima capped at 12 weeks to visual/anatomic stability. The primary efficacy endpoint was the mean change in best-corrected visual acuity (BCVA) as measured by the changes in ETDRS letter score from baseline to Week 52. Mean changes in central retinal thickness (CRT), proportion of subjects who gained ≧ 15 ETDRS letters form baseline to Week 52, and proportion of subjects with ≧ 2-step improvement in DRSS were also examined. Safety assessment included adverse events (AEs), physical examinations, vital signs, and clinical safety laboratory tests.
Results :
Mean BCVA was significantly higher at Week 52 (66.6 ± 12.5 letters) than at baseline (58.3 ± 11.9 letters). The improvement in BCVA from baseline to Week 52 was 8.3 letters (p < .0001). Mean CST was significantly lower at Week 52 (296.2 ± 88.9 μm) than at baseline (440.6 ± 126.8 μm, p < .0001). Proportion of subjects who gained at least 3 lines from baseline to Week 52 was 22.2%, while 13.6 % of subjects had at least 2-step improvement in DRSS. Eighty-seven percent (39/45) of patients reached either functional or anatomical disease stability and entered T&E at Week 20, while 88.9 % (40/45) of patients reached longest injection interval of 12 weeks at Week 52. The mean number of injections during the study period was 7.67 ± 1.54. The safety profile demonstrated the injection of aflibercept with T&E regimen was well-tolerated.
Conclusions :
The easy-to-follow criteria in this study was applicable in daily practice of DME management with good efficacy and minimum burden. Treat-and-extend regimen of aflibercept demonstrated a favorable visual and anatomical outcomes in DME patients at Week 52 with similar safety profiles as observed before.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.