A 12-month Prospective Study to Evaluate the Efficacy of Treat and Extend Regimen (T&E) of Intravitreal Aflibercept as a Second-Line Treatment for Diabetic Macular Edema (TADI Study)

Abstract

Purpose : To evaluate the efficacy of intravitreal aflibercept as a second-line therapy in eyes with persistent diabetic macular edema (DME) despite initial bevacizumab treatment.

Methods : A prospective multicenter study was conducted in Israeli retina clinics. Inclusion criteria included DME treated with at least 6 bevacizumab injections. Central subfield thickness (CST) according to SD-OCT was >300 microns with presence of subretinal and/or intraretinal fluid and best corrected ETDRS visual acuity (BCVA) between 20/30 to 20/200. Exclusion criteria included other ophthalmic pathologies associated with macular edema and recent ophthalmic surgical procedure. Eyes were treated with intravitreal aflibercept injections. Starting from the first follow-up (1 month after the first aflibercept injection), a treat-and-extend (T&E) regimen was applied. Treatment intervals were extended by 2 weeks when the macula appeared dry per SD-OCT. Primary outcome was CST thickness at week 52.

Results : Forty-eight eyes (n=43 patients) from 9 centers were recruited to the study, and 44 eyes completed 52 weeks of follow-up. Mean age±SD was 62.3±9 years, and the patients received a mean of 7.9±3.5 bevacizumab injections before enrolment. There was no improvement of CST under bevacizumab therapy. HbA1c levels at baseline and at week 52 were 8.2±1.9% and 8.2±1.7%, respectively (p>0.05). The mean (±SD) CST under intravitreal aflibercept therapy reduced from a baseline of 468±130.9 micron to 305.5±67.4 micron at 52 weeks (p<0.05). BCVA improved from 64.1±15.6 ETDRS letters at baseline to 75.2±8.4 letters at week 52 (p<0.05). Twenty of the eyes (41%) were extended beyond 4-weeks interval, and have received a mean of 10.94±2 injections of the maximal possible 13 injections during the study.

Conclusions : Eyes with persistent DME under initial bevacizumab therapy show marked reduction in macular thickness and improvement of visual acuity following one year treatment with intravitreal aflibercept using T&E algorithm.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.