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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Unknown status
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Intravitreal dexamethasone implant
Vitrectomy
Sponsored by
Anders Kvanta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Proliferative Diabetic Retinopathy focused on measuring PDRP, vitreous hemorrhage, vitrectomy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin

Sites / Locations

  • St. Erik Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Intravitreal Ozurdex

Arm Description

Vitrectomy only

Intravitreal Ozurdex after vitrectomy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2011
Last Updated
September 24, 2014
Sponsor
Anders Kvanta
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1. Study Identification

Unique Protocol Identification Number
NCT01478737
Brief Title
Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Official Title
A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Kvanta

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Diabetic Retinopathy
Keywords
PDRP, vitreous hemorrhage, vitrectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Vitrectomy only
Arm Title
Intravitreal Ozurdex
Arm Type
Active Comparator
Arm Description
Intravitreal Ozurdex after vitrectomy
Intervention Type
Drug
Intervention Name(s)
Intravitreal dexamethasone implant
Other Intervention Name(s)
OZURDEX® (dexamethasone intravitreal implant)
Intervention Description
Intravitreal Ozurdex after vitrectomy
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy
Intervention Description
Vitrectomy only
Primary Outcome Measure Information:
Title
Reoperation
Description
The proportion of patients that, due to re-bleeding within 12 months, have a second PPV
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rebleeding
Description
The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with vitreous hemorrhage undergoing PPV for PDRP Exclusion Criteria: Previous PPV Vitreous hemorrhage of non-PDRP origin
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Kvanta, PhD
Email
anders.kvanta@sankterik.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Kvanta, PhD
Organizational Affiliation
St. Erik Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Erik Eye Hospital
City
Stockholm
State/Province
NonUS
ZIP/Postal Code
11282
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Kvanta, PhD
Email
anders.kvanta@sankterik.se

12. IPD Sharing Statement

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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

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