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M. Goldbaum, K. G. Csaky; Impact of Retinal Cysts on Outcomes in Patients With Diabetic Macular Edema Treated With Pegaptanib Sodium. Invest. Ophthalmol. Vis. Sci. 2008;49(13):3465.
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To evaluate the impact of the presence of retinal cysts on functional and anatomical outcomes in patients with diabetic macular edema (DME) treated with pegaptanib sodium.
A randomized, double-masked, dose-ranging, phase 2 study, included subjects with visual acuity (VA) between 20/50 and 20/320 who suffered from clinically significant DME affecting the center of the macula, and who could safely defer photocoagulation therapy for 16 weeks. Intravitreous injections of pegaptanib (0.3, 1, or 3 mg) or sham injections were administered at baseline, weeks 6 and 12, and every 6 weeks following, up to week 30, if indicated, to a maximum of 6 injections. Macular photocoagulation was allowed after week 12 at the investigator’s discretion. Presence of retinal cysts was based on masked assessment of Optical Coherence Tomography (OCT) by an independent reading center.
At baseline, 59 pegaptanib-treated subjects had no retinal cyst on OCT and 57 had cysts. Mean VA at baseline was similar across groups (mean≈20/80), but on average, maculas with cysts were thicker than those without (500 µm vs. 418 µm). Mean changes from baseline to week 12 in VA and center point thickness were similar between those with (+3.9 letters; -23 µm) and without (+2.9 letters; -31 µm) cysts. In a subgroup analysis subjects with smaller cysts (n=12) had better anatomical outcomes at week 12 than subjects with larger ones (n=43), but similar visual results.
In this preliminary analysis there was no clear signal that the response to pegaptanib in DME differs between cystic and non-cystic cases. Results of further analyses will be presented to investigate the effect of anti-VEGF therapy in different anatomic presentations of diabetic macular edema by OCT.
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