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Diana V. Do, Quan D. Nguyen, Afsheen A. Khwaja, Roomasa Channa, Yasir J. Sepah, David S. Boyer, Jeffrey S. Heier, Jennifer I. Lim, Peter A. Campochiaro, READ 2 Study Group; Aggressive Anti-VEGF Treatment is Necessary to Control Diabetic Macular Edema in Many Patients: Month 36 Outcomes of the READ2 Trial. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5332.
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The Ranibizumab for Edema of the mAcula in Diabetes (READ2) trial compared ranibizumab (RBZ) injections (group 1) to laser (group 2) and RBZ + laser (group 3) for 6 months and then patients were seen every 2 months (groups 1 and 2) or 3 months (group 3) and received assigned treatment or RBZ for foveal thickness (FTH) > 250 µm. This prn regimen provided substantial benefit in all 3 groups at month (M) 24, but was not sufficient to eliminate macular edema in many patients. To determine if more aggressive treatment could provide increased benefit, patients who agreed to continue participation after M24 returned every month and received RBZ if foveal thickness was >250 µm.
Of the 30, 24, and 25 patients in groups 1, 2, and 3 who continued after M24, 28, 22 and 24 completed M36.
The mean improvement in BCVA between baseline and M36 was 10.3, 1.4, 9.5 letters, compared to 7.1, 3, and 7.1 in the same patients at M24. The percentage of patients who gained ≥3 lines from baseline was 35.7, 9.1, and 25 at M36 compared to 25, 9.1, and 20.8 at M24. With a mean number of injections of 5.5, 4.6, and 2.9, mean FTH was reduced from 352.4, 300.7, and 249.8 µm at M24 to 282.3, 264.7, and 214.5 µm at M36. The percentage of patients with FTH ≤ 250 µm was 39.3, 68.2, 87.5 at M36 compared to 32.1, 45.4, and 66.7 at M24. There were no drug related ocular or systemic adverse events.
A change in protocol allowing prn RBZ treatment every month instead of every 2 months resulted in a significant reduction in mean FTH and improvement in BCVA in groups 1 and 3. This suggests that many patients with DME require frequent injections of RBZ to optimally control edema and maximize vision.
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