Aflibercept May Improve Anatomic Progression in Nonproliferative Diabetic Retinopathy, But Not Visual Acuity

A study published in JAMA investigated the use of aflibercept in patients with nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) and found that while the treatment led to significant anatomical improvement, it did not improve visual acuity after 4 years. 

“Anti–vascular endothelial growth factor (VEGF) injections in eyes with nonproliferative diabetic retinopathy without center-involved diabetic macular edema reduce development of vision-threatening complications from diabetes over at least 2 years, but whether this treatment has a longer-term benefit on visual acuity is unknown,” said researchers.  

This study aimed to compare the outcomes of visual acuity and rates of vision-threatening complications in eyes with moderate to severe NPDR treated with intravitreal aflibercept vs sham. The randomized clinical trial enrolled 328 adults with moderate to severe NPDR and was conducted at 64 clinical sites in the US and Canada from January 2016 to March 2018. 

Two hundred eyes were randomly assigned to receive 2.0 mg aflibercept while 199 eyes received a sham treatment, with 8 injections given at defined intervals over 2 years, continuing quarterly if there was no improvement, to treat high-risk proliferative diabetic retinopathy (PDR) or CI-DME with vision loss. Development of PDR or CI-DME with vision loss (10 or less letters at 1 visit or 5 or less letters at 2 consecutive visits) and change in visual acuity from baseline to 4 years. 

Among participants with a mean age of 56 years, 42.4% of whom were female and had varying racial backgrounds but were predominantly White (45%), the likelihood of developing PDR or CI-DME with vision loss over a 4-year period was significantly lower with aflibercept compared to the control group (adjusted hazard ratio, .40 [97.5% CI, 0.28 to 0.57]; P<.001). However, there was no significant difference in the change in visual acuity between the aflibercept and sham groups (adjusted mean difference, −.5 letters [97.5% CI, −2.3 to 1.3]; P=.52). 

“Among patients with NPDR but without CI-DME, at 4 years treatment with aflibercept vs sham, initiating aflibercept treatment only if vision-threatening complications developed, resulted in statistically significant anatomic improvement but no improvement in visual acuity,” said researchers. “Aflibercept as a preventive strategy, as used in this trial, may not be generally warranted for patients with NPDR without CI-DME.” 

Reference  

Maturi RK, Glassman AR, Josic K, et al. Four-year visual outcomes in the protocol w randomized trial of intravitreous aflibercept for prevention of vision-threatening complications of diabetic retinopathy. JAMA. 2023;329(5):376–385. doi:10.1001/jama.2022.25029