Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 24, 2014
Last verified: September 2014
  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:


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: September 2015
Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: September 24, 2014
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
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Eye Hemorrhage
Hemorrhage
Pathologic Processes
Vascular Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 20, 2014