Abstract
Purpose :
To compare the efficacy and safety of intravitreal aflibercept injection (IAI) versus sham in moderately severe to severe nonproliferative diabetic retinopathy (NPDR) in patients without diabetic macular edema (DME).
Methods :
Eligible patients were ≥18 years with type 1 or 2 diabetes mellitus and moderately severe to severe NPDR (DRSS score 47 or 53), absence of center-involved DME (CI-DME), and baseline best-corrected visual acuity (BCVA) score of ≥69 letters (approximately ≥20/40) in the study eye. A total of 402 eyes were randomized to IAI 2 mg q16 weeks after 3 monthly doses and one q8 interval (2q16, n=135), IAI 2 mg q8 weeks after 5 monthly doses (2q8, n=134), or sham (n=133). The primary endpoint was the proportion of eyes with a ≥2-step improvement in DRSS score at week 52. Data were analyzed to determine the visual and anatomic outcomes at 100 weeks (year 2).
Results :
Overall, 44.0% of patients were women, with a mean (SD) age of 55.7 (10.5) years. The mean (SD) baseline BCVA score was 82.4 (6.0) letters. At week 52, 65% and 80% of 2q16 and 2q8 eyes, respectively, versus 15% of sham eyes had a ≥2-step improvement in DRSS score (P<0.0001 for both). In addition, 9% and 15% of 2q16 and 2q8 eyes, respectively, versus <1% of sham eyes had a ≥3-step improvement in DRSS score (nominal P<0.001 for both). Through week 52, 4% of 2q16 eyes and 3% of 2q8 eyes versus 20% of sham eyes (P<0.0001 for both) developed a vision threatening complication (VTC; proliferative diabetic retinopathy or anterior segment neovascularization), and IAI significantly reduced the risk of developing a VTC by 85% and 88% compared to sham (2q16 and 2q8 groups, respectively). The incidence of CI-DME was lower in the 2q16 (7%) and 2q8 (8%) groups versus the sham group (26%, P<0.001 for both), and IAI significantly reduced the risk of developing CI-DME by 79% and 73% in the 2q16 and 2q8 groups, respectively. No new safety signals were identified with IAI over the first year of the study. There were 90%, 91% and 80% of patients in the 2q16, 2q8 and sham groups, respectively, who entered year 2. The 100-week results will be presented.
Conclusions :
IAI improved diabetic retinopathy and prevented disease progression in eyes with moderately severe to severe NPDR in patients without DME.
This is a 2020 ARVO Annual Meeting abstract.