Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

NCT ID: NCT01478737

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Proliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham

Vitrectomy only

Group Type SHAM_COMPARATOR

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy only

Intravitreal Ozurdex

Intravitreal Ozurdex after vitrectomy

Group Type ACTIVE_COMPARATOR

Intravitreal dexamethasone implant

Intervention Type DRUG

Intravitreal Ozurdex after vitrectomy

Interventions

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Intravitreal dexamethasone implant

Intravitreal Ozurdex after vitrectomy

Intervention Type DRUG

Vitrectomy

Vitrectomy only

Intervention Type PROCEDURE

Other Intervention Names

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OZURDEX® (dexamethasone intravitreal implant)

Eligibility Criteria

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Inclusion Criteria

* Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria

* Previous PPV
* Vitreous hemorrhage of non-PDRP origin
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anders Kvanta

OTHER

Sponsor Role lead

Responsible Party

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Anders Kvanta

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anders Kvanta, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Erik Eye Hospital

Locations

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St. Erik Eye Hospital

Stockholm, NonUS, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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PDRPOZU1

Identifier Type: -

Identifier Source: org_study_id

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