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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00347698 |
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Date of registration:
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30/06/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Intravitreal Bevacizumab Vs Photocoagulation for Proliferative Diabetic Retinopathy
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Scientific title:
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Intravitreal Bevacizumab Vs Panretinal Photocoagulation for the Treatment of Proliferative Diabetic Retinopathy: A One-Year Prospective, Contralateral Eye Study |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00347698 |
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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: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Mexico
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Contacts
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Name:
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Yoko Burgoa |
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Address:
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Telephone:
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+52 (55) 1084 1400 |
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Email:
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retinamex@yahoo.com |
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Affiliation:
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Name:
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Gerardo García-Aguirre, MD |
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Address:
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Telephone:
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+52 (55) 10841400 |
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Email:
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retinamex@yahoo.com |
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Affiliation:
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Name:
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Gerardo García-Aguirre, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asociación para Evitar la Ceguera en México |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- symmetric proliferative diabetic retinopathy without high risk characteristics
- age 18 years or older
- patient consent
Exclusion Criteria:
- heart attack or cerebrovascular attack
- only eye
- retinal detachment
- vitreous haemorrhage
- previous treatment for diabetic retinopathy
- media opacities that preclude visualization of the fundus
- pregnancy
- inability to understands the implications of the protocol
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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Diabetic Retinopathy
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Intervention(s)
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Procedure: panretinal photocoagulation
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Drug: intravitreal injection of bevacizumab
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Primary Outcome(s)
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Best corrected visual acuity at six months and one year
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Score on a patient satisfaction scale at six months and one year
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Macular thickness measured by OCT at six months and one year
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Median deviation in visual fields at one year
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Secondary Outcome(s)
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Complications associated to each treatment
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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