Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Anders Kvanta100 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

100

Conditions

Proliferative Diabetic Retinopathy

Interventions

Intravitreal dexamethasone implantDRUG

Intravitreal Ozurdex after vitrectomy

VitrectomyPROCEDURE

Vitrectomy only

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with vitreous hemorrhage undergoing PPV for PDRP Exclusion Criteria: * Previous PPV * Vitreous hemorrhage of non-PDRP origin

Locations (1)

St. Erik Eye Hospital

Stockholm, NonUS, Sweden

Outcomes

Primary Outcomes

Reoperation

The proportion of patients that, due to re-bleeding within 12 months, have a second PPV

Time frame: 12 months

Secondary Outcomes

Rebleeding

The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously

Time frame: 12 months

Data from ClinicalTrials.gov

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