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Clinical Trials/NCT04140201
NCT04140201
Unknown
Phase 4

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

Alaa Hassan ElBaz0 sites80 target enrollmentFebruary 2020

Overview

Phase
Phase 4
Intervention
Fenofibrate 200mg
Conditions
Diabetic Retinopathy
Sponsor
Alaa Hassan ElBaz
Enrollment
80
Primary Endpoint
The 80 participants will be evaluated through reduction of macular edema
Last Updated
6 years ago

Overview

Brief 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

Detailed 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

Registry
clinicaltrials.gov
Start Date
February 2020
End Date
August 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Alaa Hassan ElBaz
Responsible Party
Sponsor Investigator
Principal Investigator

Alaa Hassan ElBaz

Assistant lecturer at beni suef university

Beni-Suef University

Eligibility Criteria

Inclusion Criteria

  • type 2diabetes
  • Non proliferative diabetic retinopathy

Exclusion Criteria

  • Uncontrolled glycemic level
  • proliferative diabetic retinopathy

Arms & Interventions

Receive oral hypoglycemic +fibrate

Fenofibrate +standard treatment

Intervention: Fenofibrate 200mg

Receive oral hypoglycemic +omega 3

Eicosapentanoic acid + standard treatment

Intervention: Omega 3 fatty acid

Receive oral hypoglycemic +statin

Simvastatin + standard treatment

Intervention: Simvastatin 40mg

Outcomes

Primary Outcomes

The 80 participants will be evaluated through reduction of macular edema

Time Frame: 18 weeks

assessed by ocular coherence tomography

Secondary Outcomes

  • The 80 participants will be evaluated through reduction of cardiovascular risk(18 weeks)

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