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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01478737 |
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Date of registration:
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21/11/2011 |
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Primary sponsor: |
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Public title:
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Intravitreal Ozurdex After Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
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Scientific title:
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A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01478737 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Anders Kvanta, PhD |
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Address:
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Telephone:
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Email:
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anders.kvanta@sankterik.se |
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Affiliation:
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Name:
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Anders Kvanta, PhD |
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Address:
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Telephone:
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Email:
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anders.kvanta@sankterik.se |
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Affiliation:
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Name:
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Anders Kvanta, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Erik Eye Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with vitreous hemorrhage undergoing PPV for PDRP
Exclusion Criteria:
- Previous PPV
- Vitreous hemorrhage of non-PDRP origin
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Proliferative Diabetic Retinopathy
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Intervention(s)
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Drug: Intravitreal dexamethasone implant
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Procedure: Vitrectomy
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Primary Outcome(s)
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Reoperation
[Time Frame: 12 months]
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Secondary Outcome(s)
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Rebleeding
[Time Frame: 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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