Change in Pigment Epithelial Detachment Volume and its Relationship with Subretinal Fluid and Visual Acuity in Patients with Exudative AMD after Aflibercept Switch Therapy. Post hoc analysis from the ARI2 Study.

Abstract

Purpose : The ARI2 study was a multicentric, phase IIIb open label study that aimed at establishing the efficacy and safety of Aflibercept Intra vitreal treatment (IVT) switch therapy for persitant pigment epithelium detachment PED. This post hoc analysis explores the correlation between modifications in PED and the presence of subretinal fluid as well as the relationship between PED and best corrected visual acuity (BCVA).

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 (≥ 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. PED volume calculations were perfomed with ReVAnalyzer (ADCIS, Saint-Contest, France). 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 (STATA v13.0, StataCorp LP, Texas, USA).

Results : Mean PED volume reduction from baseline values was statistically significant at the primary and secondary endpoints (p <0.0001). There was a statistically significant correlation between reduction in PED volume and presence ofsubretinal fluid at the 12 week and 32 week endpoints (p < 0.008 and p < 0.002 respectively). There was no association between BCVA changes and PED volume nor any correlation between the presence sub retinal fluid and BCVA changes, either at the primary or secondary endpoints.

Conclusions : Aflibercept switch therapy seems effective at reducing PED volume in wet AMD patients previouslyunresponsive to Ranibizumab therapy. Reduction in PED volume was strongly correlated to the dissapearence of subretinal fluid in this cohort of patients. We conclude that Aflibercept is effective in reducing neovascular activity (represented by exudation as subretinal fluid) in patients with recalcitrant PED detachments. However, no evidence of direct association between PED volume modifications and BCVA improvement was found

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.