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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01478737

Enrollment

100

Registered

2011-11-23

Start date

2011-11-30

Completion date

2016-04-30

Last updated

2024-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Diabetic Retinopathy

Keywords

PDRP, vitreous hemorrhage, vitrectomy

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.

Interventions

DRUGIntravitreal dexamethasone implant

Intravitreal Ozurdex after vitrectomy

PROCEDUREVitrectomy

Vitrectomy only

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion criteria

* Previous PPV * Vitreous hemorrhage of non-PDRP origin

Design outcomes

Primary

Measure	Time frame	Description
Reoperation	12 months	The proportion of patients that, due to re-bleeding within 12 months, have a second PPV

Secondary

Measure	Time frame	Description
Rebleeding	12 months	The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026