Abstract
Purpose:
AURORE is a multicenter retrospective observational study that aims to describe the treatment patterns with verteporfin plus ranibizumab in patients with subfoveal wet AMD over 12 months of treatment. The main objective of the study was to assess the average number of Ranibizumab intravitreal injections (IVT).
Methods:
132 consecutive wet AMD patients were included by 12 centers. Eyes had to be treatment naïve at inclusion and only be treated with verteporfin plus ranibizumab over the 12-month period following treatment initiation. Ranibizumab treatment had to be initiated with 3 monthly consecutive IVT injections. Verteporfin could be administered from 8 days before up to 12 months after ranibizumab treatment initiation. Mean ETDRS VA change at 12 months vs baseline, average number of verteporfin treatments and average number of monitoring visits over the 12-month period were part of the secondary evaluation criteria. The sample size calculation was performed to provide a minimal absolute precision of ± 0.33 IVT for the main criteria with an SD estimate of 2.1 IVT.
Results:
Most included patients were female (66.7%), more than 75 years old (79.5%) at baseline. Mean VA was 50.4 ± 18.5 ETDRS letters and bilateral wAMD was present in 29.8% of the patients at inclusion. Mean lesion size was 1892.4 ± 932.6 µm. Mean follow-up was 11.4 ± 0.7 months. The average number of ranibizumab IVT injections over the follow-up period was 5.4 ± 2.1 (CI 95% [5.1; 5.8]) and the average number of verteporfin treatments was 1.5 ± 0.8 (CI 95% [1.3; 1.6]). Most patients (70.5%) received only one verteporfin treatment. Reduced fluence (RF; ca. 300 mW/cm2, 25 J/cm2, 83 s) was used. Mean VA change at the end of the follow-up period was 7.4 ± 11.9 letters (CI95% [5.4; 9.5]). The mean number of monitoring visits was 6.4 ± 1.8 (CI95% [6.1; 6.7]) over the follow-up period. 96.2% of eyes lost fewer than 15 letters and 27.3% of eyes gained 15 or more letters.
Conclusions:
Ranibizumab combined with reduced fluence verteporfin PDT markedly improved mean VA despite a relatively low number of monitoring visits and of treatments.
Keywords: 412 age-related macular degeneration •
466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials •
647 photodynamic therapy