NCT01478737

Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Anders Kvanta · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate if intravitreal Ozurdex can reduce the incidence of recurrent vitreous hemorrhage after primary pars plana vitrectomy (PPV) in patients with proliferative diabetic retinopathy (PDRP).

Detailed description

To perform a randomized, controlled, study on patients that undergo PPV for vitreous hemorrhage secondary to PDRP. Half of the patients will receive an intravitreal Ozurdex implant immediately after surgery. The primary outcome measure is the proportion of patients that, due to rebleeding within 12 months, have a second PPV. Secondary outcome measures include the number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously.

Conditions

• Proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Intravitreal dexamethasone implant	Intravitreal Ozurdex after vitrectomy
PROCEDURE	Vitrectomy	Vitrectomy only

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2011-11-23
• Last updated: 2024-01-30

Locations

1 site across 1 country: Sweden