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Tareq Ziad Jaouni, Rita Ehrlich, Yoreh Barak, Haia Katz, Russell Pokroy, Jaime Levy, Joel Hanhart, Ori Segal, Shiri Shulman, Michaella Goldstein, Liran Tiossano, Itay Chowers; 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). Invest. Ophthalmol. Vis. Sci. 2019;60(9):3641.
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To evaluate the efficacy of intravitreal aflibercept as a second-line therapy in eyes with persistent diabetic macular edema (DME) despite initial bevacizumab treatment.
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.
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.
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.
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