NCT01487044

A Single-Center Trial of High Frequency Pegaptanib for Rapid Restoration of VEGF Levels in Diabetic Retinal Edema

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Retina Institute of Hawaii · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Macugen (Pegaptanib Sodium)	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.

Timeline

• First posted: 2011-12-07
• Last updated: 2011-12-07

Locations

1 site across 1 country: United States