Incidence, Risk Factors and Outcomes of Submacular Hemorrhage with Loss of Vision in Neovascular Age-Related Macular Degeneration in Daily Clinical Practice: the Fight Retinal Blindness! Registry

Abstract

Purpose : To report the estimated incidence, cumulative rate, risk factors, and outcomes of submacular hemorrhage (SMH) with loss of vision in neovascular age-related macular degeneration (nAMD) receiving intravitreal injections (IVT) of vascular endothelial growth factor (VEGF) inhibitor in routine clinical practice.

Methods : Retrospective analysis of treatment-naïve eyes receiving IVT of VEGF inhibitors (ranibizumab, aflibercept, or bevacizumab) for nAMD from 1 January 2010 to 31 December 2020 that were tracked in the Fight Retinal Blindness! registry. Estimated incidence, cumulative rate, and hazard ratios (HR) of SMH with loss of vision were measured using Poisson regression, Kaplan-Meier survival curves, and Cox-proportional hazards models. Locally weighted scatterplot smoothing curves were used to plot visual acuity (VA) between SMH cases and matched controls.
The main outcome measures were the estimated incidence of SMH with loss of vision and change in VA 12 months after SMH.

Results : This study included 7642 eyes (6425 patients) with a total of 135095 IVTs over a 10-year period. One hundred five eyes developed SMH with loss of vision with a rate of 1 per 1283 injections (0.08% 95% confidence interval [95%CI] [0.06; 0.09]). The estimated incidence [95%CI] was 4.6 [3.8; 5.7] SMH with loss of vision per year per 1000 treated patients during the study. The cumulative [95%CI] rate of SMH per patient did not increase significantly with each successive injection (p = 0.947). Men (hazard ratio [HR] [95%CI] = 1.71 [1.26; 2.16] vs. women, p = 0.019) and patients with disciform scar CNV type (HR = 12.35 [10.76, 13.94] vs. Type 1 CNV; P = 0.002) at baseline were significantly more likely to develop SMH with loss of vision in our study. There was little evidence that SMH was related to under-treatment. SMH cases had a mean VA drop of around 6 lines at diagnosis, which then improved moderately to a 4-line loss at one year.

Conclusions : SMH with loss of vision is an uncommon complication that can occur at any time in eyes treated for nAMD in routine clinical practice, with only limited recovery of vision one year later.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.