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B. M. Wirostko, L.-J. Hwang, C. Bosworth, D. Zhou, C. Starita, R. Buggage, G. E. Lang; Treatment Modality and Structural/Functional Changes Over 82 Weeks in Patients With Diabetic Macular Edema (DME). Invest. Ophthalmol. Vis. Sci. 2008;49(13):3498.
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To evaluate the relationship between structural and functional changes and treatment modality in a population of DME patients.
This was a post hoc analysis of 86 patients from an 82-week Phase 2 study of DME. Patients received pegaptanib 0.3 mg or sham injections every 6 weeks for 30 weeks, and after week 12 could receive focal laser if indicated. Patients who received pegaptanib (n=44) or sham (n= 42) were stratified as: pegaptanib alone, pegaptanib plus focal laser (pegaptanib/laser), sham alone (no treatment), or sham plus laser (sham/laser). Correlation analyses were used to evaluate the relationship between mean change in retinal thickness (OCT) and mean change in visual acuity (VA) at weeks 6, 12, 18, 24, 30, 36, 52, and 82.
The pegaptanib alone and pegaptanib/laser groups showed better mean VA improvement vs sham/laser at all time points after week 12. Mean VA change was consistently better for pegaptanib alone vs sham alone (8/8 time points; p=0.0039). Sham alone was better than sham/laser at 5/8 time points after week 18 (p=ns). While the sham alone group showed a positive correlation between OCT center point thinning and VA improvement across the 8 time points (r= 0.5370; p=0.1700), sham/laser continued OCT center point thinning with deterioration of VA with a significant negative correlation (r = -0.7832; p=0.0215). No significant correlations between OCT center point thinning and VA improvement were observed in the pegaptanib alone (r=-0.1860; p=0.6591) or pegaptanib/laser groups (r=-0.3613; p=0.3792).
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