Proliferative Diabetic Retinopathy Clinical Trial
NCT number | NCT01921192 |
Other study ID # | 1/2012 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | August 8, 2013 |
Last updated | August 8, 2013 |
Start date | September 2012 |
Homocysteine, a well-known inducer of vascular endothelial cell damage has been associated with extracellular matrix changes. Many studies demonstrated that high levels of this aminoacid in diabetic patients increases significantly the risk of the development of this pathology. This study has been undertaken to investigate the role of homocysteine and its cofactors (folic acid, vitamin B6 and B12) during the progression of the diabetic retinopathy.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - diabetic patients with proliferative and non proliferative retinopathy Exclusion Criteria: - Patients with chronic liver disease Patients with kidney disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University of Catania, Cannizzaro Hospital | Catania |
Lead Sponsor | Collaborator |
---|---|
University of Catania |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | vitamin B6 | 12 months | Yes | |
Other | vitamin B12 | 12 months | Yes | |
Primary | homocysteine | 12 months | Yes | |
Secondary | folic acid | 12 months | Yes |
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