Associations and outcomes of patients with submacular haemorrhage secondary to age-related macular degeneration in the IVAN trial

Purpose: To compare demographics, visual acuity (VA) and retinal morphology between those with and without baseline submacular haemorrhage (SMH) for patients enrolled in the Inhibit VEGF in Age-related Choroidal Neovascularisation trial (IVAN). Design: Secondary analyses of RCT image and clinical data. Methods Setting: Clinical trial data collected in 23 UK hospitals.Study Population: IVAN study eyes (with untreated neovascular age-related macular degeneration (nAMD) at randomisation) with at least 12 months’ follow-up and adequate imaging.Intervention: Study eyes randomly assigned between monthly ranibizumab, as-needed ranibizumab, monthly bevacizumab or as-needed bevacizumab. Imaging at baseline graded independently for presence, type, position and extent of SMH.Main Outcome Measures: Visual acuity (primary outcome), subretinal fibrosis, atrophic scarring and retinal thickness outcomes at 12 and 24 months. Results: 535 of 605 IVAN trial participants were included. Patients with SMH at baseline (286, 53%) were older (p=0.010), and affected eyes were more likely to have intraretinal fluid present (p=0.038). VA was significantly worse in those with baseline SMH at month 0 (p<0.001; estimate of difference 6 letters with 95% confidence intervals of 4 to 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.