NCT01589718

A Study of the Safety, Tolerability, and Efficacy of IVT Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Management of Tractional Retinal Detachment and Vitreous Hemorrhage With Proliferative Diabetic Retinopathy

A Phase III Randomized 1:1, Masked, Study of the Safety, Tolerability, and Efficacy of Intravitreal Pre-op 0.3mg Pegaptanib Sodium Versus Sham, for Adjuvant Management of TRD and Vit Hem Associated With PDR

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Greater Houston Retina Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.

Detailed description

Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugen™ prior to surgery versus sham injection. Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery. Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule. Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Macugen	one intravitreal injection of Macugen prior to vitrectomy surgery
DRUG	Sham	The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-05-02
• Last updated: 2014-03-05

Locations

1 site across 1 country: United States