Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- Procedure: Vitrectomy
- Registration Number
- NCT01478737
- Lead Sponsor
- Anders Kvanta
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients with vitreous hemorrhage undergoing PPV for PDRP
- Previous PPV
- Vitreous hemorrhage of non-PDRP origin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Vitrectomy Vitrectomy only Intravitreal Ozurdex Intravitreal dexamethasone implant Intravitreal Ozurdex after vitrectomy
- Primary Outcome Measures
Name Time Method Reoperation 12 months The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
- Secondary Outcome Measures
Name Time Method Rebleeding 12 months The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously
Trial Locations
- Locations (1)
St. Erik Eye Hospital
🇸🇪Stockholm, NonUS, Sweden