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NCT04140201 Clinical Trial

Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Diabetic Retinopathy Clinical Trial

Official title:
Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04140201
Other study ID # Diabetic Retinopathy
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date February 2020
Est. completion date August 2020

Study information
Verified date January 2020
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigator study evaluate the effect of different lipid lowering agents on the progression of diabetic retinopathy and other reduction of cardiovascular risk of diabetic patients

Description:

The investigator study compare the effect of lipid lowering agent on the enhancement of visual acuity and on reduction of macular edema in patients with diabetic retinopathy and also compare their effect on reduction of cardiovascular risk on diabetic patients via assessment of ASCVD risk score

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date August 2020
Est. primary completion date June 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- type 2diabetes

- Non proliferative diabetic retinopathy

Exclusion Criteria:

- Uncontrolled glycemic level

- proliferative diabetic retinopathy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Simvastatin 40mg
Drugs that lower lipid level
• Fenofibrate 200mg
Drugs that lower lipid levels
• Omega 3 fatty acid
Drugs that lower lipid levels

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alaa Hassan ElBaz

Outcome
Type Measure Description Time frame Safety issue
Primary The 80 participants will be evaluated through reduction of macular edema assessed by ocular coherence tomography 18 weeks
Secondary The 80 participants will be evaluated through reduction of cardiovascular risk assessed by ASCVD risk score 18 weeks
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