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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

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ClinicalTrials.gov Identifier: NCT01478737
Recruitment Status : Unknown
Verified September 2014 by Anders Kvanta, St. Erik Eye Hospital.
Recruitment status was:  Recruiting
First Posted : November 23, 2011
Last Update Posted : September 25, 2014
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Drug: Intravitreal dexamethasone implant Procedure: Vitrectomy Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Study Start Date : November 2011
Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015


Arms and Interventions

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 Name: OZURDEX® (dexamethasone intravitreal implant)


Outcome Measures

Primary Outcome Measures :
  1. Reoperation [ Time Frame: 12 months ]
    The proportion of patients that, due to re-bleeding within 12 months, have a second PPV


Secondary Outcome Measures :
  1. Rebleeding [ Time Frame: 12 months ]
    The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478737


Contacts
Contact: Anders Kvanta, PhD anders.kvanta@sankterik.se

Locations
Sweden
St. Erik Eye Hospital Recruiting
Stockholm, NonUS, Sweden, 11282
Contact: Anders Kvanta, PhD       anders.kvanta@sankterik.se   
Sponsors and Collaborators
Anders Kvanta
Investigators
Principal Investigator: Anders Kvanta, PhD St. Erik Eye Hospital
More Information

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT01478737     History of Changes
Other Study ID Numbers: PDRPOZU1
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by Anders Kvanta, St. Erik Eye Hospital:
PDRP
vitreous hemorrhage
vitrectomy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Vitreous Hemorrhage
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Eye Hemorrhage
Hemorrhage
Pathologic Processes
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action