Purchase this article with an account.
Jennifer I Lim; Intravitreal Aflibercept Injection for Nonproliferative Diabetic Retinopathy: Year 2 Results from the PANORAMA Study. Invest. Ophthalmol. Vis. Sci. 2020;61(7):1381.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
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).
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).
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.
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.
This PDF is available to Subscribers Only