- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140201
Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
January 15, 2020 updated by: Alaa Hassan ElBaz
Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- type 2diabetes
- Non proliferative diabetic retinopathy
Exclusion Criteria:
- Uncontrolled glycemic level
- proliferative diabetic retinopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Receive oral hypoglycemic +omega 3
Eicosapentanoic acid + standard treatment
|
Drugs that lower lipid levels
Other Names:
|
Active Comparator: Receive oral hypoglycemic +statin
Simvastatin + standard treatment
|
Drugs that lower lipid level
Other Names:
|
Active Comparator: Receive oral hypoglycemic +fibrate
Fenofibrate +standard treatment
|
Drugs that lower lipid levels
Other Names:
|
No Intervention: Receive oral hypoglycemic only
Standard treatment only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 80 participants will be evaluated through reduction of macular edema
Time Frame: 18 weeks
|
assessed by ocular coherence tomography
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The 80 participants will be evaluated through reduction of cardiovascular risk
Time Frame: 18 weeks
|
assessed by ASCVD risk score
|
18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
October 24, 2019
First Posted (Actual)
October 25, 2019
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 15, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
- Fenofibrate
Other Study ID Numbers
- Diabetic Retinopathy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Retinopathy
-
Retina Institute of HawaiiUnknownDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Severe Nonproliferative Diabetic Retinopathy | Mild Nonproliferative Diabetic Retinopathy | Moderate Nonproliferative Diabetic RetinopathyUnited States
-
University of CataniaUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyItaly
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Asociación para Evitar la Ceguera en MéxicoCompletedProliferative Diabetic Retinopathy | Severe Nonproliferative | Active Photocoagulated Diabetic RetinopathyMexico
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Asociación para Evitar la Ceguera en MéxicoUnknownProliferative Diabetic Retinopathy | Non Proliferative Diabetic RetinopathyMexico
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Valo Health, Inc.RecruitingProliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathyUnited States
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Asociación para Evitar la Ceguera en MéxicoUnknownNon Proliferative Diabetic Retinopathy. | Proliferative Diabetic Retinopathy.Mexico
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AEYE Health IncA. Stein Regulatory Affairs Consulting Ltd.RecruitingDiabetic Mellitus | Diabetic Retinopathy, DRUnited States
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Ocuphire Pharma, Inc.CompletedDiabetic Retinopathy | Diabetic Macular Edema | NPDR - Non Proliferative Diabetic Retinopathy | PDR - Proliferative Diabetic RetinopathyUnited States
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King Khaled Eye Specialist HospitalCompletedDiabetic Macular Edema | Proliferative Diabetic Retinopathy | Non-proliferative Diabetic RetinopathySaudi Arabia
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