Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Anders Kvanta

Status and phase: Completed; Phase 2

Conditions: Proliferative Diabetic Retinopathy

Treatments: Procedure: Vitrectomy; Drug: Intravitreal dexamethasone implant

Study type: Interventional

Funder types: Other

Identifiers

NCT01478737

PDRPOZU1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion criteria

• Previous PPV
• Vitreous hemorrhage of non-PDRP origin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Vitrectomy only

Treatment:

Procedure: Vitrectomy

Intravitreal Ozurdex

Active Comparator group

Description:

Intravitreal Ozurdex after vitrectomy

Treatment:

Drug: Intravitreal dexamethasone implant