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L.J. Singerman, Macugen Diabetic Retinopathy Study Group; Findings of the Phase 2 Trial of the Safety and Efficacy of Pegaptanib Sodium (MacugenTM) in Patients With Diabetic Macular Edema . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4674.
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Purpose: The safety and efficacy of the selective VEGF165 aptamer antagonist pegaptanib sodium (MacugenTM) was assessed as treatment for diabetic macular edema (DME). Methods: A Phase 2, double–masked, sham–controlled trial was conducted in patients with DME who had visual acuities (VA) between 20/50 and 20/320 and who could safely defer photocoagulation. Intravitreous pegaptanib sodium (0.3 mg, 1 mg, 3 mg) or sham injections were administered every 6 weeks for 12 weeks (3 injections); continued injections and/or macular laser were optional, thereafter. Endpoints were VA and retinal thickness (OCT2) at week 36 and the need for focal/grid laser therapy between weeks 12 – 36. Results: 172 randomized patients were well matched with regard to baseline characteristics. At week 36, mean VA was better for the 0.3 mg subgroup compared with sham (P=0.042). Those receiving 0.3 mg had stable or improved vision compared with sham (≥0 lines gained; 73% vs. 51%; P= 0.023); ≥5 letters gained (59% vs. 34%; P=0.010); ≥10 letters gained (34% vs. 10%; P=0.003) and ≥15 letters gained (18% vs. 7%; P=0.12). Additionally, patients receiving 0.3mg pegaptanib sodium showed a decrease in mean retinal thickness in the central part of the central subfield of –68.0 microns compared to +3.7 microns with sham (P=0.021). More of those treated with 0.3 mg as compared with sham had an absolute decrease of both ≥100 microns (42% vs. 16%; P=0.021) and ≥75 microns (49% vs. 19%; P=0.0078). Focal/grid laser intervention was necessary in fewer eyes in the 0.3 mg group than in the sham–treated group (25% vs. 48%; P=0.042). All pegaptanib sodium doses were well tolerated. One case of endophthalmitis occurred in 652 total injections (0.15% per injection) and was not associated with severe visual loss. Conclusions: Pegaptanib sodium is both well tolerated and efficacious in the treatment of DME. Patients receiving the 0.3 mg dose showed better visual acuity, a greater reduction in central retinal thickness, and less need for laser therapy.
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