Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

ID: NCT01478737
Status: Unknown status
Phase: Phase 2
Start Date: November 01, 2011
First Submitted: November 21, 2011
Last Updated: September 24, 2014
Results: N/A
Organization: St. Erik Eye Hospital
Sponsors & Collaborators: Anders Kvanta
Location: Sweden
Conditions: Proliferative Diabetic Retinopathy
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Study Description

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.
Condition or disease Intervention/treatment Phase

Proliferative Diabetic Retinopathy

Drug: Intravitreal dexamethasone implant
Other Names
OZURDEX® (dexamethasone intravitreal implant)
Procedure: Vitrectomy
Other Names
Phase 2

Tracking Information

First Submitted DateNovember 21, 2011
Last Update Posted DateSeptember 24, 2014
Start DateNovember 01, 2011
Anticipated Completion DateSeptember 01, 2015
Primary Completion DateSeptember 01, 2014
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Reoperation [Time Frame: 12 months]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Rebleeding [Time Frame: 12 months]

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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIntravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Official TitleA Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
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.

Study TypeInterventional
Study PhasePhase 2
Estimated Enrollment
100
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
Primary Purpose
Prevention
Conditions
Proliferative Diabetic Retinopathy
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Intravitreal dexamethasone implant

Intravitreal Ozurdex after vitrectomy

Other Names
OZURDEX® (dexamethasone intravitreal implant)
Procedure: Vitrectomy

Vitrectomy only

Other Names
Study Groups/Cohorts
Sham
Vitrectomy only

Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy

Study Arms
Active Comparator Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy
Drug : Intravitreal dexamethasone implant
Intravitreal Ozurdex after vitrectomy

Sham Comparator Sham
Vitrectomy only
Procedure : Vitrectomy
Vitrectomy only

Arm Intervention/Treatment
Active Comparator Intravitreal Ozurdex
Intravitreal Ozurdex after vitrectomy
Drug : Intravitreal dexamethasone implant
Sham Comparator Sham
Vitrectomy only
Procedure : Vitrectomy

Recruitment Information

Recruitment Status:Unknown status
Enrollment100
Completion DateSeptember 01, 2015
Eligibility Criteria: Inclusion Criteria:
- Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:
- Previous PPV
- Vitreous hemorrhage of non-PDRP origin
GenderAll
Age12 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Sweden

Administrative Information

NCT Number:NCT01478737
Other Study ID Numbers
PDRPOZU1
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyAnders Kvanta, St. Erik Eye Hospital
Study Sponsor
Anders Kvanta
Collaborators
Not Available
Investigators
Principal Investigator
Anders Kvanta, PhD
St. Erik Eye Hospital