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Petr Kolar, Giovanni Staurenghi, Cornelia Dunger-Baldauf, Wayne Macfadden; Efficacy and safety of ranibizumab treatment guided by functional and/or anatomical criteria in patients with neovascular age-related macular degeneration: results from the OCTAVE study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):903.
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© ARVO (1962-2015); The Authors (2016-present)
Ranibizumab is approved for the treatment of neovascular AMD (nAMD) worldwide. Retreatment decisions in patients with nAMD are often guided by vision loss; however, evidence suggests that anatomical changes may precede visual loss. Anatomical monitoring using optical coherence tomography (OCT) in addition to visual assessments may help physicians with their retreatment decisions in patients treated with ranibizumab. 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.
OCTAVE was a 24-month, Phase IIIb, randomized, multicenter, double-masked study conducted in 24 countries. Patients were initially randomized 1:1 into one of two groups, in which re-treatment was based on criteria guided by (i) loss of BCVA due to nAMD (Gp I; n=335) or (ii) BCVA loss due to nAMD and/or signs of disease activity on OCT(Gp II; n=336). The study was terminated prematurely, as the use of OCT became the standard of care in re-treatment decisions after the project was initiated. Presented here are efficacy data from patients who completed at least 12 months, and safety data from the entire population. The data were analyzed using descriptive statistics.
Overall, 671 patients were enrolled in this study. The baseline demographics and ocular characteristics were well balanced in both groups (Table 1). The mean change in BCVA (±SD) from baseline in patients completing 12months of follow-up in Gp I and Gp II was 6.7 (±13.48; n =151) and 8.3 (±13.53; n=154) ETDRS letters, respectively [p=0.3, 95% CI (-1.44; 4.64)] (Figure 1). The proportion of patients gaining ≥5, ≥10, and ≥15 letters at Month 12 is shown in Figure 1. The most commonly reported ocular AEs in both groups (Gp I/II; n=334/336) were increase in intra-ocular pressure (3.6%/ 6.3%), conjunctival hemorrhage (5.7%/3%), and eye pain (3.0%/2.7%). Most common non-ocular AEs (Gp I/II; n=334/336) were nasopharyngitis (7.2%/3.3%), hypertension (5.4%/4.8%), and influenza (4.5%/4.5%).
OCTAVE showed that ranibizumab treatment led to significant visual gains regardless of the retreatment criteria. This study further supports the well-established safety and efficacy profile of ranibizumab in patients with nAMD.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.
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