Associations and Outcomes of Patients with Submacular Hemorrhage Secondary to Age-related Macular Degeneration in the IVAN Trial

Abstract

To compare demographics, visual acuity (VA) and retinal morphology between those with, and without baseline submacular hemorrhage (SMH) for patients enrolled in the Inhibit VEGF in Age-related Choroidal Neovascularization trial (IVAN). Secondary analyses of a randomized, controlled trial of image and clinical data. Setting; The IVAN trial collected data in 23 UK hospitals. Study population; IVAN study eyes (with untreated neovascular age-related macular degeneration at randomization) with at least 12 months of follow-up and adequate imaging. Intervention; Study eyes were randomly assigned between monthly ranibizumab, as-needed ranibizumab, monthly bevacizumab, or as-needed bevacizumab. Imaging at baseline was graded independently for the presence, type, position, and extent of SMH. Main outcome measures; The main outcome measures were VA (primary outcome), subretinal fibrosis, atrophic scarring, and retinal thickness outcomes at 12 and 24 months RESULTS: Of 605 IVAN trial participants, 535 were included in this analysis. Patients with SMH at baseline (286 [53%]) were older (P=.010) and affected eyes were more likely to have intraretinal fluid present (P=.038). The VA was significantly worse in those with baseline SMH at month 0 (P < .001; estimate of difference 6 letters; 95% CIs, 4-8 letters), but the difference decreased and was not significant at month 12 or 24. No significant association was found between baseline SMH and subretinal fibrosis, atrophic scarring, or central retinal thickness. The presence of SMH at baseline was associated with age, intraretinal fluid, and decreased baseline VA. By month 12, VA was no longer significantly different in those who presented with SMH at baseline.