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3 Month Outcome of Ziv-aflibercept for DME

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ziv aflibercept
Sponsored by
Marashi Eye Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, Anti VEGF, VEGF trap, Diabetes, Diabetic retinopathy, ZALTRAP, Ziv aflibercept

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with central diabetic macular edema
  • Best corrected visual acuity is 20/25 or less
  • Central macular thickness more than 250 microns
  • Patients who are able to come for all follow-up

Exclusion Criteria:

  • Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  • Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
  • For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
  • Macular edema is present that is considered to be related to ocular surgery such as cataract extraction
  • Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
  • History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
  • Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Ziv aflibercept

    Arm Description

    Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks

    Outcomes

    Primary Outcome Measures

    Proportion of visual acuity improvement using Snellen chart or equivalent

    Secondary Outcome Measures

    Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
    Amount of treatment cost in USD dollars
    Number of eyes with retinal toxicity after ziv aflibercept treatment

    Full Information

    First Posted
    May 11, 2016
    Last Updated
    July 3, 2017
    Sponsor
    Marashi Eye Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02772497
    Brief Title
    3 Month Outcome of Ziv-aflibercept for DME
    Official Title
    Three-month Outcome of Ziv-aflibercept for Diabetic Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Marashi Eye Clinic

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose is to show the 3-month efficacy and safety in diabetic macular edema treated with intravitreal ziv-aflibercept.
    Detailed Description
    Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but it is expansive where ziv aflibercept (ZALTRAP) has the same molecule but with high osmilar buffer solution which is FDA approved for colon rectus cancer treatment and it is cost effective. Studies have shown that intravitreal ziv aflibercept is safe and nontoxic despite the high osmolarity and even has short term effect in wet age related macular degeneration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Macular Edema
    Keywords
    DME, Anti VEGF, VEGF trap, Diabetes, Diabetic retinopathy, ZALTRAP, Ziv aflibercept

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ziv aflibercept
    Arm Type
    Experimental
    Arm Description
    Intravitreal ziv aflibercept 1.25 mg (0.05ml) every 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Ziv aflibercept
    Other Intervention Name(s)
    ZALTRAP
    Intervention Description
    Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
    Primary Outcome Measure Information:
    Title
    Proportion of visual acuity improvement using Snellen chart or equivalent
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Amount of Central macular thickness reduction in microns after ziv-aflibercept treatment
    Time Frame
    3 months
    Title
    Amount of treatment cost in USD dollars
    Time Frame
    3 months
    Title
    Number of eyes with retinal toxicity after ziv aflibercept treatment
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with central diabetic macular edema Best corrected visual acuity is 20/25 or less Central macular thickness more than 250 microns Patients who are able to come for all follow-up Exclusion Criteria: Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years. Macular edema is present that is considered to be related to ocular surgery such as cataract extraction Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more History of major ocular surgery (including vitrectomy, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization. Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ameen Marashi, MD
    Organizational Affiliation
    Aleppo Syria
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Marashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114
    Results Reference
    result
    Links:
    URL
    http://medcraveonline.com/AOVS/AOVS-04-00114.pdf
    Description
    Marashi A (2016) Three-Month Outcome of Ziv-Aflibercept for Diabetic Macular Edema. Adv Ophthalmol Vis Syst 4(3): 00114. DOI: 10.15406/aovs.2016.04.00114

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    3 Month Outcome of Ziv-aflibercept for DME

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