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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

This study is currently recruiting participants.
Verified June 2012 by St. Erik Eye Hospital
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital
ClinicalTrials.gov Identifier:
NCT01478737
First received: November 21, 2011
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Proliferative Diabetic Retinopathy
 Drug: Intravitreal dexamethasone implant
Procedure: Vitrectomy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Erik Eye Hospital:

Primary Outcome Measures:
  • Reoperation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The proportion of patients that, due to re-bleeding within 12 months, have a second PPV


Secondary Outcome Measures:
  • Rebleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The number of episodes of vitreous hemorrhage that occur within 12 months after surgery but clear spontaneously


Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT01478737     History of Changes
Other Study ID Numbers: PDRPOZU1
Study First Received: November 21, 2011
Last Updated: June 5, 2012
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
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
 Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on June 18, 2013