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Effects of Oral Fenofibrate on Retinal Thickness and Macular Volume

NCT04885153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-05-13

No results posted yet for this study

Summary

Lipid levels in the blood are proposed to play a role in the progression of diabetic retinopathy. Lipid levels can be controlled with dyslipidemic drugs, such as fenofibrate. Fenofibrate is known to prevent diabetic microvascular complications by decreasing cholesterol and triglyceride levels. This study aims to investigate the effects of oral fenofibrate on central macular thickness (CMT) and macular volume, as well as on specific biomarkers of endothelial dysfunction (eNOS), inflammation (VCAM-1), and angiogenesis (VEGF) in DR individuals with dyslipidemia.

Conditions

Interventions

DRUG

Fenofibrate

Patients were given simvastatin 10 mg and fenofibrate 200 mg daily for three months and were evaluated monthly.

DRUG

Placebo

Patients were given simvastatin 10 mg and placebo (lactic acid) 200 mg daily for three months and were evaluated monthly.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Gitalisa Andayani, MD, PhD · Department of Ophthalmology, Cipto Mangunkusumo Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-01
Primary Completion
2017-07-01
Completion
2017-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885153 on ClinicalTrials.gov