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P.A. Campochiaro, Q.D. Nguyen, S. Tatlipinar, S.M. Shah, J.A. Haller, P. Singletary, D.V. Do, J. Handa; Results of an Open Label Phase 1/2 Study Assessing the Effects of Multiple Intravitreous Injections of Ranibizumab in Patients With Diabetic Macular Edema . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5443.
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To investigate the safety, tolerability, and bioactivity of multiple intravitreous injections of 0.5 mg of ranibizumab in patients with diabetic macular edema (DME).
Twenty patients (one eye for each) with foveal thickness greater than 250 µm due to DME were given an intravitreous injection of 0.5 mg of ranibizumab at baseline and 1, 2, 4, and 6 months after baseline. The primary outcome measure was change in visual acuity (number of letter read by ETDRS protocol) from baseline at 7 months. Secondary outcome measures were change from baseline in excess foveal thickness and excess macular volume by optical coherence tomography (OCT) at 7 months and several other time points, and change from baseline in visual acuity at several time points.
At present, 10 patients have completed the month–6 visit and all 20 patients have completed the month–3 visit. There have been no ocular or systemic adverse events and no ocular inflammation. Compared to baseline, at 6 months the first 10 patients showed a mean increase of 11 ETDRS letters read, a mean decrease of 50% in excess foveal thickness (163 µm), and a mean decrease of 52% in excess macular volume (1.6 mm3). The 6–month results of all 20 patients will be presented.
Five intravitreous injections of 0.5 mg of ranibizumab have been well–tolerated in 10 patients and have caused improvement in DME. A larger randomized, controlled trial investigating the efficacy of ranibizumab for treatment of DME is indicated.
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