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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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ISRCTN |
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Last refreshed on:
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21 May 2018 |
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Main ID: |
ISRCTN99532788 |
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Date of registration:
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23/04/2009 |
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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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Effect of trimetazidine MR 35 mg on the emergence of choroidal neovascularisation in age-related macular degeneration
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Scientific title:
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Study of the effect of trimetazidine MR 35 mg (2 tabs/day) on the emergence of choroidal neovascularisation in age-related macular degeneration: a multicentre, randomised, double-blind, placebo-controlled, phase III study in 1100 patients treated for 3 to 5 years |
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Date of first enrolment:
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19/03/1999 |
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Target sample size:
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1100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN99532788 |
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Study type:
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Interventional |
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Study design:
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Randomised double-blind controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Belgium
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France
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Spain
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Contacts
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Name:
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Christian
Corbe |
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Address:
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Institution des Invalides
6 Boulevard des Invalides
75007
Paris
France |
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Telephone:
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Email:
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Male and female
2. Caucasian
3. Aged 55 to 83 years with age-related macular degeneration
4. Neovascularisation on the first eye
Exclusion criteria: 1. Cataract
2. Diabetic retinopathy
3. Optical neuropathy
4. Neovascularisation on the studied eye
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Aged-related macular degeneration
Eye Diseases
Other retinal disorders
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Intervention(s)
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Oral administration of trimetazidine 35 mg or placebo during 3 to 5 years.
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Primary Outcome(s)
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Effect on choroidal neovascularisation evaluated each year.
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Secondary Outcome(s)
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1. Effect of the serous drusen evaluated each year
2. Evaluation of pigment epithelium lesion evaluated each year
3. Clinical acceptability of trimetazidine evaluated each 6 months
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Secondary ID(s)
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MC3-06790-001
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval was obtained before recruitment of the first participants
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/10/2005 |
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URL:
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