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D. V. Do, J. S. Heier, S. M. Shah, A. Khwaja, D. S. Boyer, J. I. Lim, P. Abraham, P. A. Campochiaro, Q. D. Nguyen, READ 2 Study Group; Two-Year Results of the READ 2 Study: Ranibizumab for Edema of the Macula in Diabetes. Invest. Ophthalmol. Vis. Sci. 2010;51(13):5842.
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To describe the changes in best corrected visual acuity (BCVA) and excess retinal thickness (ERT) in subjects with 2-year follow-up in the READ 2 study, which is a phase 2, randomized clinical trial evaluating ranibizumab (RBZ) compared to focal laser or combination therapy (RBZ plus focal laser) in eyes with diabetic macular edema (DME).
98 out of 126 subjects completed the month-24 visit. Subjects were initially randomized 1:1:1 into one of 3 groups: RBZ 0.5mg (group 1); focal laser from baseline (BL) to month 6 (group 2) with laser or RBZ (0.5mg) after month 6; and RBZ (0.5mg) with focal laser combination therapy from BL to month 6 with continued combination therapy or monotherapy with RBZ starting after month 6 (group 3). After month 6, the decision on type of treatment was at the discretion of investigators. Re-treatment criterion for all groups starting at month 6 included central retinal thickness ≥ 250µm on optical coherence tomography (OCT).
At month 6, the primary endpoint of the study, mean change in BCVA (in letters) was +7.2 in group 1, -0.4 in group 2, and +3.8 in group 3. Starting at month 6, the majority of treatments given in all 3 groups from month 6 to 24 included monotherapy with RBZ. At month 24, the mean change in BCVA (in letters) was +7.6 in group 1, +5.0 in group 2, and +6.4 in group 3. ERT on OCT at month 24 was +125.6 µm, +75.5 µm, and +58.4 µm for groups 1, 2, and 3, respectively. There were no drug related ocular or systemic adverse events.
Treatment of DME with RBZ for 24 months appears safe and results in an improvement in BCVA and a reduction in ERT on OCT. Additional studies and long-term analyses of the READ 2 study are needed to determine the optimal dosing schedule of RBZ in eyes with DME.
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