A 12-Month Prospective Study To Evaluate The Efficacy Of Using The Treat-And-Extend Regimen With Intravitreal Aflibercept As A Second-Line Treatment For Diabetic Macular Oedema (The Tadi Study)

Purpose To evaluate the efficacy of intravitreal aflibercept as a second-line therapy in eyes with persistent diabetic macular oedema (DMO) despite receiving initial bevacizumab treatment. Methods A prospective multicentre study was conducted in nine academic clinics in Israel. Starting from the first follow-up visit, a treat-and-extend regimen was applied in which the treatment intervals were extended by 2 weeks based on macular thickness using SD-OCT. The primary outcome was central subfield thickness (CST) at week 52. Results Forty-four patients (n = 48 eyes) were recruited to the study, and 43 eyes completed 52 weeks of follow-up. Patients received a mean (+/- SD) of 7.9 +/- 3.5 bevacizumab injections before enrolment. The mean (+/- SD) CST under aflibercept therapy decreased from 468 +/- 131 mu m at baseline to 303 +/- 67 mu m at 52 weeks (p = 0.002), and best corrected visual acuity improved from 64 +/- 15 ETDRS letters at baseline to 75 +/- 8 letters at week 52 (p = 0.001). Twenty (46%) eyes met the treat-and-extend criteria and received a mean (+/- SD) of 10.9 +/- 2 aflibercept injections. Conclusions Eyes with persistent DMO following initial bevacizumab therapy had a marked reduction in macular thickness and improved visual acuity following 1 year of treatment with intravitreal aflibercept. Less than half of the patients met eligibility criteria for extension of the treatment interval; for these patients, the treat-and-extend regimen resulted in a maximum treatment interval of 10 weeks during the first year.