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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.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01165697
Date of registration: 16/07/2010
Prospective Registration: No
Primary sponsor: Ohio State University
Public title: Establishment of Biomarkers for Fabry Disease
Scientific title: Establishment of Biomarkers for Fabry Disease
Date of first enrolment: July 2010
Target sample size: 4
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01165697
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Deborah M Grzybowski, PhD
Address: 
Telephone:
Email:
Affiliation:  Ohio State University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Fabry patient

- evidence of angiopathy (renal, cardiac, or ocular)

- Patients above the age of 18

Exclusion Criteria:

- Patients unable or unwilling to provide written informed consent will not be recruited

- Patients who are below the age of 18

- Patients who have not or will not be undergoing Fluorescein angiography

- Allergy to fluorescein

- Pregnant women and fetuses are exclude from the study due to risks related to
fluorescein and no direct benefit to the pregnant woman and fetus



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Fabry Disease
Intervention(s)
Other: Fluorescein angiography
Primary Outcome(s)
Presence of specific findings commonly associated with Fabry's disease using neuroretinal examination [Time Frame: every 6 months, for up to 3 years]
Secondary Outcome(s)
Capillary perfusion abnormalities in optic nerve and retina [Time Frame: every 6 months, for up to 3 years]
Secondary ID(s)
2009H0137
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Genzyme, a Sanofi Company
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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