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Interim results of the aflibercept as a second line therapy for neovascular age related macular degeneration in Israel (ASLI) study

Session Details

Session Title: AMD II

Session Date/Time: Friday 18/09/2015 | 14:30-16:00

Paper Time: 14:30

Venue: Calliope.

First Author: : N.Mathalone ISRAEL

Co Author(s): :    I. Chowers   O. Segal   A. Polack   R. Erlich   Y. Barak   I. Klemperer

Abstract Details

PURPOSE:To evaluate the treatment with intravitreal aflibecept in patients with neovascular age-related macular degeneration (nvAMD) showing partial or lack of response for initial therapy with intravitreal bevacizumab.

Setting:

The ASLI study is a prospective, multi-center, open-label, clinical trial.

Methods:

Three monthly intravitreal aflibercept (2mg) injections were administered followed by two bi-monthly injections (weeks 16 and 24), and a final examination at week 28th. According to the investigator decision, additional injection was given at week 20. All patients underwent a complete ophthalmic examination, including measurement of Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA), and spectral-domain optical coherence tomography (SD-OCT) at every visit. Baseline and final fluorescein angiography were performed. Change in the central sub-field macular thickness (CST) from baseline to week 28 on OCT was considered the primary end-point. Secondary end-points included the mean change in BCVA, and structural changes in OCT and fluorescein angiography (FA).

Results:

After 6 months from initiation of the study, 34 patients were recruited with mean±SD age of 76±8 years. Ten (29%) patients completed the study. The mean±SD number of bevacizumab intravitreal injections prior to enrollment to the study was 5.2±2.3 (range 3-9). After 2 loading injections the CST improved significantly and reduced from mean±SD of 465±137 microns at baseline to 358±114 microns at week 8 (n=20, p=0.04; paired T-Test). Mean BCVA for the 10 patients who completed the study improved from 0.43±0.3 LogMAR at baseline to 0.34±0.1 LogMAR at week 28 (p=0.01, paired T-Test).

Conclusions:

Interim results from the ASLI study demonstrate decrease in CST after the first 2 aflibercept injections, and improved BCVA at the end of the study. These preliminary results suggest that intravitreal aflibercept may be effective in nvAMD eyes with lack or partial response to bevacizumab treatment. Further follow-up on the entire study cohort is required to validate the findings.

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