A Phase III b, Multicenter Study of the Efficacy and Safety of Aflibercept Switch in Patients With Exudative AMD With Retinal Pigment Epithelium Detachment, Previously Treated With Ranibizumab Intravitreal Injections. The ARI2 Study.

摘要

Purpose : To evaluate the safety and efficacy of Aflibercept intra vitreal injections (IVT) switch therapy to induce regression in pigment epithelium detachment (PED) height on patients previously extensively treated by Ranibizumab IVT. The primary outcome measure was change in maximal PED height from baseline to 12 weeks. Secondary outcome measures include: change in maximal PED height from baseline to 32 weeks as well as change in central retinal thickness, change in best corrected visual acuity (BCVA) and change in PED volume from baseline to 12 and 32 weeks. Methods : Prospective, phase IIIb, open label, multi center study. Patients had to meet the following criteria: active subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, at least 12 months previous Ranibizumab injections (a?￥ 8 injections) and PED 250 ?μm with persisting sub retinal fluid at baseline. Patients were switched to Aflibercept, receiving 3 consecutive IVT treatments at 4 weeks intervals (primary endpoint). Patients continued to receive Aflibercept IVT at 6 weeks intervals for the remainder of the study. Paired T-test was used to compare paired-data. Comparisons of unpaired means or medians were performed using the T-test or Mann-Whitney test. Results : A total of 82 patients were analyzed. Mean age at inclusion was 80.65 years. Mean reduction in maximal PED height from baseline to 12 weeks was 78.81 microns (p 0.0001). At 32 weeks, reduction of maximal PED height compared to baseline was 58 microns; the statistical significance was maintained (p 0.0001). Mean BCVA was 0.36, 0.34 and 0.31 logMAR, at baseline, 12 weeks and 32 weeks time points respectively (improvement in BCVA was statistically significant at 32 weeks (p = 0.04) but not at 12 weeks (p 0.05)). Reduction in PED volume from baseline (mean= 1.33 mm3) to week 12 (mean= 0.95 mm3) was statistically significant (p 0.0001). Conclusions : According to the results in this study, Aflibercept switch therapy seems to be effective in reducing PED volume and height in patients not responding to Ranibizumab therapy. Visual acuity improvement was also observed. This is the largest controlled study analyzing PED response to anti VEGF switch therapy. This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.