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Clinical Trials |

Ranibizumab for Edema of the Macula in Diabetes Study:  3-Year Outcomes and the Need for Prolonged Frequent Treatment

Diana V. Do, MD; Quan D. Nguyen, MD, MSc; Afsheen A. Khwaja, MD; Roomasa Channa, MD; Yasir J. Sepah, MBBS; Raafay Sophie, MD; Gulnar Hafiz, MD, MPH; Peter A. Campochiaro, MD ; for the READ-2 Study Group
JAMA Ophthalmol. 2013;131(2):139-145. doi:10.1001/2013.jamaophthalmol.91.
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Objective To assess the benefit of increased follow-up and treatment with ranibizumab between months 24 and 36 in the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study.

Design Prospective, interventional, multicenter follow-up of a randomized clinical trial.

Methods Patients who agreed to participate between months 24 and 36 (ranibizumab, 28 patients; laser, 22; and ranibizumab + laser, 24) returned monthly and received ranibizumab, 0.5 mg, if foveal thickness (FTH, center subfield thickness) was 250 μm or greater. Main outcome measures were improvement in best-corrected visual acuity (BCVA) and reduction in FTH between months 24 and 36.

Results Mean improvement from the baseline BCVA in the ranibizumab group was 10.3 letters at month 36 vs 7.2 letters at month 24 (ΔBCVA letters = 3.1, P = .009), and FTH at month 36 was 282 μm vs 352 μm at month 24 (ΔFTH = 70 μm, P = .006). Changes in BCVA and FTH in the laser group (−1.6 letters and −36 μm, respectively) and the ranibizumab + laser group (+2.0 letters and −24 μm) were not statistically significant. The mean number of ranibizumab injections was significantly greater in the ranibizumab group compared with the laser group (5.4 vs 2.3 injections, P = .008) but not compared with the ranibizumab + laser group (3.3, P = .11).

Conclusions More aggressive treatment with ranibizumab during year 3 resulted in a reduction in mean FTH and improvement in BCVA in the ranibizumab group. More extensive focal/grid laser therapy in the other 2 groups may have reduced the need for more frequent ranibizumab injections to control edema.

Application to Clinical Practice Long-term visual outcomes for treatment of diabetic macular edema with ranibizumab are excellent, but many patients require frequent injections to optimally control edema and maximize vision.

Trial Registration clinicaltrials.gov Identifier:NCT00407381

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Figure 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram of the Ranibizumab for Edema of the Macula in Diabetes (READ-2) Study through month 36. CNV indicates choroidal neovascularization; RBZ, ranibizumab.

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Figure 2. Changes in mean best-corrected visual acuity (BCVA) from baseline in patients with diabetic macular edema who completed 3 years of follow-up in the ranibizumab (RBZ) group, laser group, and RBZ + laser group. Statistical comparisons made between month 24 and month 36 values for the same group of patients were calculated using the Wilcoxon signed rank test. ETDRS indicates Early Treatment Diabetic Retinopathy Study.

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Figure 3. Percentage of patients with diabetic macular edema who showed improvement in best-corrected visual acuity (BCVA) of 5 letters or more. The stacked bars show the percentage of patients in the ranibizumab (RBZ) group, laser group, and RBZ + laser group who gained 5 or more, 10 or more, or 15 or more letters of vision between baseline and 6 (A), 24 (B), and 36 (C) months. Data are included only for patients who remained in the study through month 36.

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Figure 4. Best-corrected visual acuity (BCVA) in Snellen equivalent in patients with diabetic macular edema who showed improvement. The bars show the percentage of patients within the listed vision ranges for the ranibizumab (RBZ) group, laser group, and RBZ + laser group at months 6 (A), 24 (B), and 36 (C). Data are included only for patients who remained in the study through month 36.

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Figure 5. Assessments of macular edema. A, Changes in center subfield thickness (foveal thickness [FTH]) over time. The lines show the mean FTH at baseline and months 6, 12, 24, and 36 in the ranibizumab (RBZ) group, laser group, and RBZ + laser group. Statistical comparisons between the month 24 and month 36 values in the same group of patients were calculated using the Wilcoxon signed rank test. B and C, The percentage of patients with FTH less than 250 μm, FTH between 250 and 500 μm, and FTH more than 500 μm are shown in the RBZ, laser, and RBZ + laser groups at months 24 and 36. Data are included only for patients who remained in the study through month 36.

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