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J. L. Prenner, RACE Study Group; The RACE Study: Bevasiranib for the Treatment of Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2007;48(13):5045.
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To evaluate the efficacy of Bevasiranib, a novel small interfering RNA pharmaceutical, in the treatment of diabetic macular edema (DME).
Prospective, randomized, controlled, phase 2 clinical trial of 48 eyes of 48 patients with DME. DME was confirmed by an independent reading center by optical coherence tomography (OCT). All eyes received three injections of drug, in one of three escalating dose groups, one month apart. Final data was acquired at four weeks after the last injection. OCT, fluorescein angiography, visual acuity, and clinical examinations were all recorded.
The primary end point, the average OCT thickness, did not change significantly after three injections (-8.9 um (range -548 to +310 um)). The average visual acuity did not change significantly after three injections (+0.1 letters (range -39 to +21)). Subsequent data analysis displayed a significant reduction in OCT thickness after 4-8 weeks compared to the peak thickness. This suggests an expected efficacy lag consistent with the drug mechanism.
Bevasiranib was safe and effective in eyes with DME. Longer studies with larger study cohorts are required to detail the efficacy of this novel drug further.
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