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Christine A. Kiire, Rupal Morjaria, Emily Fletcher, Li Ping Chow, Spyridon Charisis, Sami Habal, Robert Purbrick, Amy Smith, N Victor Chong; Intravitreal Pegaptanib for Ischemic Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2012;53(14):388.
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To assess the effect of 5 intravitreal pegaptanib sodium 0.3 mg (Macugen [TM]) injections, given 6 weeks apart, on the foveal avascular zone (FAZ), central foveal thickness (CFT) and visual acuity (VA) in diabetic patients with ischemic diabetic macular edema (DME). This group of patients has been excluded from most of the previous clinical trials.
A phase IV, open-labelled, prospective study. The diagnosis of ischemic DME was based on enlargement and irregularity of the FAZ on fundus fluorescein angiography, in addition to CFT > 300 microns and macular edema as detected on optical coherence tomography. Visual acuity at enrolment was between 20/32 and 20/320. Sixteen participants received all 5 intravitreal injections of pegaptanib sodium. Changes in their FAZ area, CFT and LogMAR VA over the 30 week treatment period were recorded.
All except one of the participants had type II diabetes. The male:female ratio was 3:1. Sixteen participants received the intended 5 injections. At baseline, their mean (95% confidence interval) FAZ area was 1260 pixels (932-1588), mean CFT was 466 micrometers (414-518) and the mean corrected VA was 54.4 letters (46-63). After 5 pegaptanib sodium injections the mean FAZ area reduced to 1203 pixels (p = 0.51), CFT reduced to 408 micrometers (p = 0.03) and corrected VA increased to a mean of 57.6 letters (p = 0.24). Overall, of those who completed the course of treatment, 5 participants had a reduction in FAZ area, a reduction in CFT and an improvement in VA. One had a reduction in FAZ area and CFT without an improvement in VA and 1 had an improvement in VA without an improvement in FAZ area or CFT. One of the 16 had an increase in FAZ area, an increase in CFT and deterioration in VA.
Intravitreal pegaptanib sodium 0.3 mg appears to be a safe treatment option for patients with ischemic DME. The overall benefit is moderate but there is no significant increase in ischemia. Four (25%) gained > 10 letters, and in each case this was associated with a reduction in CFT, although not always an improvement in foveal perfusion.
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