Establish the efficacy of initial high frequency loading of intravitreal pegaptanib bi-weekly during the initial treatment period when the VEGF levels are the greatest and then gradually extending the administration frequency to monthly as homeostasis ensues for the treatment of DME, as measured by best-corrected visual acuity.
Determine if high frequency loading intravitreal pegaptanib will reduce the area and/or volume of DME, as assessed by Spectral Domain optical coherence tomography (SD-OCT) and to determine if this loading with gradual taper schedule of intravitreal pegaptanib will reduce the need for macular laser treatment.
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Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment. Pegaptanib sodium is formulated at 0.3mg/90µl and presented in USP Type I glass barrel syringes sealed with a bromobutyl rubber plunger stopper. The syringe has a needle attachment at allows for a 30-guage need to be fixed to the syringe prior to injection. The stoppered syringe is packaged in a foil pouch. The drug product is preservative-free and intended for single use by intravitreous injection only.
Retina Institute of Hawaii
Honolulu, Hawaii, United States
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