Incidence and associations of Retinal pigment epithelial (RPE) tear post-loading phase of aflibercept 2mg in Treatment Naïve Neovascular Age-Related Macular Degeneration (nAMD): PRECISE study report 10.

PURPOSE: To report the incidence of retinal pigment epithelial (RPE) tears following three monthly 2-mg aflibercept injections in treatment-naïve neovascular age-related macular degeneration (nAMD) and to identify associated risk factors. METHODS: Treatment-naïve patients aged ≥50 years with nAMD and baseline visual acuity (VA) between 24 and 78 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters were included. RPE tears were diagnosed on optical coherence tomography (OCT) as a definite discontinuity of the RPE. Logistic regression using Generalized Estimating Equations (GEE) was performed to account for correlated eye data and identify factors associated with RPE tear development. Cluster bootstrap receiver operating characteristic (ROC) curve analysis assessed the predictive value of baseline pigment epithelial detachment (PED) height. RESULTS: A total of 1,929 eyes were analyzed; 67 eyes (3.5%) developed an RPE tear after the aflibercept loading phase. Multivariable analysis adjusted for age, ethnicity, and sex showed that male sex, poorer baseline VA, increased central subfield thickness, hemorrhagic PED, increased PED height, presence of subretinal hyperreflective material (SHRM), and polypoidal choroidal vasculopathy (PCV) were associated with higher odds of RPE tear and that presence of drusen with decreased odds of RPE tear. ROC analysis demonstrated that a baseline PED height of 244 µm optimally predicted RPE tear development with a sensitivity of 73.8% and a specificity of 73.6%. CONCLUSION: RPE tears occurred in 3.5% of treatment-naïve nAMD eyes after aflibercept loading phase. Several baseline clinical and imaging risk factors were identified to be significantly associated with RPE tear development.