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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2014 by St. Erik Eye Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital Identifier:
First received: November 21, 2011
Last updated: September 24, 2014
Last verified: September 2014
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.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with vitreous hemorrhage undergoing PPV for PDRP

Exclusion Criteria:

  • Previous PPV
  • Vitreous hemorrhage of non-PDRP origin
  Contacts and Locations
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Please refer to this study by its identifier: NCT01478737

Contact: Anders Kvanta, PhD

St. Erik Eye Hospital Recruiting
Stockholm, NonUS, Sweden, 11282
Contact: Anders Kvanta, PhD   
Sponsors and Collaborators
Anders Kvanta
Principal Investigator: Anders Kvanta, PhD St. Erik Eye Hospital
  More Information

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital 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:
vitreous hemorrhage

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
Pathologic Processes
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors processed this record on October 21, 2016