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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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12 November 2012 |
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Main ID: |
NCT01492400 |
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Date of registration:
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13/12/2011 |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
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Scientific title:
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Date of first enrolment:
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March 2012 |
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Target sample size:
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300 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01492400 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Austria
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Belgium
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Brazil
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Denmark
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France
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Germany
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Israel
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Italy
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Netherlands
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Portugal
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South Africa
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Spain
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Sweden
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United Kingdom
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United States
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Contacts
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Name:
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Allergan Inc. |
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Address:
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Telephone:
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Email:
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clinicaltrials@allergan.com |
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Affiliation:
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Allergan |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of type 1 or 2 diabetes mellitus
- Diagnosis of macular edema
- Visual acuity between 20/200 to 20/40
Exclusion Criteria:
- Eye surgery to the study eye within 3 months
- Use of Ozurdex® within 9 months
- Any active ocular inflammation and infection
- Diagnosis of glaucoma
- Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic
use (e.g., Avastin®) within 6 months
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Macular Edema
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Intervention(s)
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Drug: dexamethasone Intravitreal Implant
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Drug: ranibizumab
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Primary Outcome(s)
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Change from Baseline in Best Corrected Visual Acuity (BCVA) Score
[Time Frame: Baseline, Month 12]
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Secondary Outcome(s)
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Change from Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT)
[Time Frame: Baseline, Month 12]
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Change from Baseline in Total Area of Macular Leakage Measured on Fluorescein Angiography (FA)
[Time Frame: Baseline, Month 12]
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Secondary ID(s)
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206207-024
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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