First Author: G.Staurenghi ITALY
Co Author(s): P. Kolar J. Garweg C. Dunger-Baldauf W. Macfadden
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Age-related macular degeneration (AMD) is a leading cause of visual impairment worldwide. Ranibizumab is the standard of care for treatment of neovascular AMD (nAMD). Retreatment decisions in patients with nAMD are often guided by vision loss; however, evidence suggests that anatomical changes may precede the visual loss. Anatomical monitoring using optical coherence tomography (OCT) in addition to visual assessments may help physicians with their retreatment decisions for nAMD patients. Here we present the efficacy and safety of two treatment regimens of ranibizumab 0.5 mg, based on functional and/or anatomical retreatment criteria, in patients with nAMD.
OCT-AVE was a 24-month, open-label, randomised, multicentre, double-masked study conducted across 92 sites in 24 countries.
Patients with nAMD were randomised 1:1 into group I: treatment with ranibizumab 0.5 mg and re-treatment based on best-corrected visual acuity (BCVA) loss (n=335) or group II: treatment with ranibizumab 0.5 mg and re-treatment based on BCVA loss and/or signs of disease activity on OCT (n=336). The study was terminated prematurely, as the use of OCT became the standard of care in retreatment decisions after project initiation. Here we present the efficacy data from patients who completed the 12 months of study duration (group I: n=151 group II: n=154; group I/II), and safety data from the entire population. The data were analysed using descriptive statistics.
A total of 671 patients were included in the study. The baseline demographics and ocular characteristics were well balanced in both groups. In groups I and II, the mean age (±standard deviation [SD]) was 73.9 (7.86) and 75.3 (7.91) years, and 63.6% and 57.7 % were female respectively. The mean BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letters, ±SD) at baseline was 60.9 (13.10) in group I and 60.2 (12.21) in group II. The mean change in BCVA (ETDRS letters, ±SD) from baseline at month 12 was 6.7 (13.48) in group I and 8.3 (13.53) in group II; there was no difference in visual gains between the two groups (95% CI [-1.44; 4.64]). At Month 12, the percentage of patients in group I/II gaining ≥ 5, ≥ 10, ≥ 15 ETDRS letters were 62.9/64.9; 37.1/48.1; 22.5/30.5 respectively. The overall incidence of ocular and non-ocular adverse events (AEs) was similar between both groups. The most common ocular AEs (≥5% incidence in any of the groups [group I/II; n=334/336]) were increase in intraocular pressure (3.6%/ 6.3%) and conjunctival haemorrhage (5.7%/3%). Non-ocular AEs with a ≥5% incidence in any of the groups (group I/II; n=334/336) were nasopharyngitis (7.2%/3.3%), and hypertension (5.4%/4.8%).
When concentrating on BCVA, ranibizumab treatment resulted in prominent visual gains regardless of retreatment criteria in patients with nAMD and confirmed the non-inferiority of OCT-guided retreatment decisions. The OCT-AVE study further supports the well-established safety and efficacy profile of ranibizumab in patients with nAMD.