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. CONCLUSION Presence of SMH at baseline was associated with age, intraretinal fluid and reduced baseline VA. By month 12, VA was no longer significantly different in those who presented with SMH at baseline.