A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Overview
- Phase
- Phase 2
- Intervention
- Vitrectomy
- Conditions
- Proliferative Diabetic Retinopathy
- Sponsor
- Anders Kvanta
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Reoperation
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Anders Kvanta
Professor
St. Erik Eye Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with vitreous hemorrhage undergoing PPV for PDRP
Exclusion Criteria
- •Previous PPV
- •Vitreous hemorrhage of non-PDRP origin
Arms & Interventions
Sham
Vitrectomy only
Intervention: Vitrectomy
Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy
Intervention: Intravitreal dexamethasone implant
Outcomes
Primary Outcomes
Reoperation
Time Frame: 12 months
The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
Secondary Outcomes
- Rebleeding(12 months)