search
Back to results

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

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Simvastatin 40mg
Fenofibrate 200mg
Omega 3 fatty acid
Sponsored by
Alaa Hassan ElBaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • type 2diabetes
  • Non proliferative diabetic retinopathy

Exclusion Criteria:

  • Uncontrolled glycemic level
  • proliferative diabetic retinopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    No Intervention

    Arm Label

    Receive oral hypoglycemic +omega 3

    Receive oral hypoglycemic +statin

    Receive oral hypoglycemic +fibrate

    Receive oral hypoglycemic only

    Arm Description

    Eicosapentanoic acid + standard treatment

    Simvastatin + standard treatment

    Fenofibrate +standard treatment

    Standard treatment only

    Outcomes

    Primary Outcome Measures

    The 80 participants will be evaluated through reduction of macular edema
    assessed by ocular coherence tomography

    Secondary Outcome Measures

    The 80 participants will be evaluated through reduction of cardiovascular risk
    assessed by ASCVD risk score

    Full Information

    First Posted
    October 21, 2019
    Last Updated
    January 15, 2020
    Sponsor
    Alaa Hassan ElBaz
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04140201
    Brief Title
    Effect of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
    Official Title
    Evaluation of Lipid Lowering Agents on Diabetic Retinopathy and Cardiovascular Risk of Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2020 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    August 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Alaa Hassan ElBaz

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Retinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Receive oral hypoglycemic +omega 3
    Arm Type
    Active Comparator
    Arm Description
    Eicosapentanoic acid + standard treatment
    Arm Title
    Receive oral hypoglycemic +statin
    Arm Type
    Active Comparator
    Arm Description
    Simvastatin + standard treatment
    Arm Title
    Receive oral hypoglycemic +fibrate
    Arm Type
    Active Comparator
    Arm Description
    Fenofibrate +standard treatment
    Arm Title
    Receive oral hypoglycemic only
    Arm Type
    No Intervention
    Arm Description
    Standard treatment only
    Intervention Type
    Drug
    Intervention Name(s)
    Simvastatin 40mg
    Other Intervention Name(s)
    Statin
    Intervention Description
    Drugs that lower lipid level
    Intervention Type
    Drug
    Intervention Name(s)
    Fenofibrate 200mg
    Other Intervention Name(s)
    Fibrate
    Intervention Description
    Drugs that lower lipid levels
    Intervention Type
    Drug
    Intervention Name(s)
    Omega 3 fatty acid
    Other Intervention Name(s)
    n3 FA
    Intervention Description
    Drugs that lower lipid levels
    Primary Outcome Measure Information:
    Title
    The 80 participants will be evaluated through reduction of macular edema
    Description
    assessed by ocular coherence tomography
    Time Frame
    18 weeks
    Secondary Outcome Measure Information:
    Title
    The 80 participants will be evaluated through reduction of cardiovascular risk
    Description
    assessed by ASCVD risk score
    Time Frame
    18 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: type 2diabetes Non proliferative diabetic retinopathy Exclusion Criteria: Uncontrolled glycemic level proliferative diabetic retinopathy

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs