Session Title: Miscellaneous
Session Date/Time: Saturday 13/09/2014 | 11:00-13:00
Paper Time: 11:32
Venue: Boulevard E
First Author: : L.Arias SPAIN
Co Author(s): : M.I. López-Gálvez M. Roura M. Balaña
Ranibizumab is licensed for the treatment of visual impairment due to diabetic macular edema (DME) in over 100 countries worldwide including USA and Europe. This was based on the results from multiple phase III, large, randomised, controlled clinical trials. The currently reported study was a phase II study conducted in Spain. The main aim was to determine whether there were differences in mean change in best corrected visual acuity (BCVA) from baseline after 12 months of treatment with ranibizumab 0.5 mg versus laser photocoagulation (LP).
16 specialist sites for retinal disease in Spain.
This was a phase II, multicentre, randomised, open-label, controlled trial. Patients were randomly assigned to intravitreal injection of ranibizumab (0.5 mg) with 3 loading doses and then pro-re-nata (PRN) treatment or the administration of LP (ratio 1:1). Patient inclusion criteria were: ≥18 years old, diabetes mellitus type 1 or 2 diagnosis, and altered visual acuity (VA) due to diabetic macular edema (DME) according to ETDRS. The study eye must have had a BCVA of 78-25 letters, central retinal thickness (CRT) ≥250 µm, and visual impairment due to DME. The mean BCVA change was determined by statistical comparison between the treatment groups using the Mann-Whitney U test for two independent groups in the ITT-LOCF population (intention to treat, last observation carried forward). CRT measured by OCT at each follow-up visit relative to baseline was also assessed. All statistical analyses were performed in SAS version 9.2.
83 patients were randomized: 40 ranibizumab, 43 LP. Both groups were comparable with respect to demographic baseline characteristics. Most patients were men (59.8%), mean (SD) age was 63.5(9.4) years and BMI 29.2(4.2)kg/m2. Nine patients (22.5%) with ranibizumab and 11(25.6%) with LP discontinued the study. The main reisons of discontinuation were protocol deviations (56.6% ranibizumab and 36.4% LP) and adverse events in LP (36.4%). A trend to a better BCVA change from baseline to month-12 in ranibizumab group vs LP [8.7(9.1) vs 4.0(10.6) letters, p=0.0778] was observed. At month-12, more patients with ranibizumab achieved BCVA >73 letters than LP (54% vs 24%, respectively, p=0.0090). CRT at month-1 showed a significant reduction with ranibizumab [-55.2 (62.2) m, p<0.0001] but not with LP [-21.9(82.9) m, p=0.3606]. The mean (SD) number of treatments received were 5.3(2.8) injections of ranibizumab and 2.1(1.2) LP. Mean days between visits were 32.4(3.4) and 31.3(1.9) (baseline to month-2) and 31.8(2.1) and 31.5(2.2) (month-2 to month-12), for ranibizumab and LP, respectively. Almost half of patients in each group had one treatment-emergent-adverse-event (TEAE). Five TEAEs (3 in ranibizumab, 2 in LP) were classified as serious. One patient with ranibizumab and 4 with LP discontinued the study due to TEAEs.
In this small phase II trial, treatment with ranibizumab compared to LP showed a better improvement of the BCVA after month-12 in patients with DME. Evaluation of the two treatment groups revealed a significant CRT reduction at month-1 in patients treated with ranibizumab than with LP. The safety and tolerability profile of ranibizumab was consistent with the well documented safety profile for ranibizumab from other clinical trials.