Official Title
A Single-Center Trial of Intravitreous Injections of Macugen (Pegaptanib Sodium) Given at Least 7 Days Before Vitrectomy Secondary To Tractional Retinal Detachment in Proliferative Diabetic Retinopathy
Phase
Phase 1Lead Sponsor
Retina Institute of HawaiiStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
PDRIntervention/Treatment
pegaptanib ...Study Participants
5Primary objective of this trial will be to evaluate the safety and efficacy of intravitreal injections of Macugen (pegaptanib sodium) when given at least 7-14 days prior to vitrectomy in subjects with tractional retinal detachment (with or withoutmacular involvement) secondary to proliferative diabetic retinopathy.
Secondary objective is to evaluate regression of neovascularization and progression of macular traction utilizing OCT and fundus photographs.
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 a USP Type I glass barrel syringe sealed with a bromobutyl rubber stopper. A 30-guage needle is fixed to the end of the syringe after removal of the rubber stopper. The syringe comes in a sealed foil pouch, and the 30-gauge needle is added to the sterile injection field separately. The drug product is preservative-free and intended for single use by intravitreous injection only.
Open-label, single-center trial. Subjects will recieve intravitreous injections of Macugen 7-14 days before Vitrectomy.
Inclusion Criteria: Subjects of either gender aged 75 years or below diagnosed with tractional retinal detachment secondary to proliferative diabetic retinopathy. Exclusion Criteria: Subjects with vitreous hemorrhage obscuring the posterior pole will be excluded.
