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

Alaa Hassan ElBaz

Status and phase: Unknown; Phase 4

Conditions: Diabetic Retinopathy

Treatments: Drug: Fenofibrate 200mg; Drug: Simvastatin 40mg; Drug: Omega 3 fatty acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04140201

Diabetic Retinopathy

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2diabetes
• Non proliferative diabetic retinopathy

Exclusion criteria

• Uncontrolled glycemic level
• proliferative diabetic retinopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Receive oral hypoglycemic +omega 3

Active Comparator group

Description:

Eicosapentanoic acid + standard treatment

Treatment:

Drug: Omega 3 fatty acid

Receive oral hypoglycemic +statin

Active Comparator group

Description:

Simvastatin + standard treatment

Treatment:

Drug: Simvastatin 40mg

Receive oral hypoglycemic +fibrate

Active Comparator group

Description:

Fenofibrate +standard treatment

Treatment:

Drug: Fenofibrate 200mg

Receive oral hypoglycemic only

No Intervention group

Description:

Standard treatment only