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J. Jonisch, P. J. Ferrone; Ranibizumab Dose Comparison in the Treatment of Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1347.
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To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab and 1.0 mg of ranibizumab.
Investigator sponsored prospective randomized single-blinded clinical trial. Eyes were randomized to one of two groups: 1.0 mg ranibizumab or 0.5 mg ranibizumab. Each patient received three monthly injections, followed by injections on an as needed re-treatment protocol.
A 6-month interim analysis included 31 eyes of 25 patients. The two groups did not differ significantly at baseline in average age, ETDRS letters, OCT central macular thickness, OCT macular volume, and blood pressure. The 1.0 mg group had a greater improvement of ETDRS vision when analyzed over the six month time period (p=0.03). The 1.0 mg group had an average gain of 8.92 ETDRS letters as compared with 3.50 letters gained in the 0.5 mg group (p=0.08). Mean decrease in central foveal thickness was 149.46 µm in the 1.0 mg group and 103.28 in the 0.5 mg group (p=0.22). Average number of injections in the 1.0 mg group was 3.85 as compared to 3.72 injections in the 0.5 mg group (p=0.55). There was no change in systolic or diastolic blood pressure in either group. No serious adverse events occurred on either group.
Clinical Trial: :
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