Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

January 28, 2024 updated by: Anders Kvanta

A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
    • NonUS
      • Stockholm, NonUS, Sweden, 11282
        • St. Erik Eye Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Vitrectomy only
Procedure: Vitrectomy
Vitrectomy only
Active Comparator: Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy
Drug: Intravitreal dexamethasone implant
Intravitreal Ozurdex after vitrectomy
Other Names:
  • OZURDEX® (dexamethasone intravitreal implant)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anders Kvanta

Investigators

  • Principal Investigator: Anders Kvanta, PhD, St. Erik Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimated)

November 23, 2011

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDRPOZU1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Proliferative Diabetic Retinopathy

Clinical Trials on Vitrectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe