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New Concepts in Diabetic Macular Edema (DME) (DME)

Primary Purpose

Diabetes Mellitus, With Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
INTRAVITREAL RANIBIZUMAB INJECTION
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, With Complications focused on measuring macula-injection- laser- ranibizumab-edema-thickness

Eligibility Criteria

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

Inclusion Criteria:

  • focal maculopathy
  • diffuse macular edema
  • diffuse macular edema with ischemic changes

Exclusion Criteria:

  • ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
  • patients with history of stroke or transient ischemic attack
  • hypersensitivity to ranibizumab or any component of the ranibizumab formulation
  • uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication)
  • evidence of vitreomacular traction (in either eye)
  • active proliferative diabetic retinopathy (study eye)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    visual acuity letter score

    macular thickness(CST)

    Arm Description

    visual acuity letter score is used to compare between the two groups after interventional procedures

    macular thickness(CST)is used to compare between the two groups after interventional procedures

    Outcomes

    Primary Outcome Measures

    visual acuity letter score
    The visual acuity letter score at one-year
    central subfield thickness (CST)
    the mean CST observed at one-year

    Secondary Outcome Measures

    patient compliant-complications
    subjective symptoms

    Full Information

    First Posted
    November 30, 2019
    Last Updated
    December 4, 2019
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04186702
    Brief Title
    New Concepts in Diabetic Macular Edema (DME)
    Acronym
    DME
    Official Title
    New Concepts in Diabetic Macular Edema (DME) Ranibizumab and Focal/Direct Laser for Chronic Diabetic Macular Edema With Vision Impairment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 10, 2014 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    September 9, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.
    Detailed Description
    Settings and Design: Randomized clinical study Subjects and Methods: investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, With Complications
    Keywords
    macula-injection- laser- ranibizumab-edema-thickness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    interventional model
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    A clinical trial design strategy in which parties involved in the trial, the investigator and participants, do not know which participants have been assigned which interventions. Type of masking include: double-blind masking.
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    visual acuity letter score
    Arm Type
    Active Comparator
    Arm Description
    visual acuity letter score is used to compare between the two groups after interventional procedures
    Arm Title
    macular thickness(CST)
    Arm Type
    Active Comparator
    Arm Description
    macular thickness(CST)is used to compare between the two groups after interventional procedures
    Intervention Type
    Procedure
    Intervention Name(s)
    INTRAVITREAL RANIBIZUMAB INJECTION
    Other Intervention Name(s)
    focal/direct argon laser
    Intervention Description
    interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
    Primary Outcome Measure Information:
    Title
    visual acuity letter score
    Description
    The visual acuity letter score at one-year
    Time Frame
    one-year follow up
    Title
    central subfield thickness (CST)
    Description
    the mean CST observed at one-year
    Time Frame
    one-year follow up
    Secondary Outcome Measure Information:
    Title
    patient compliant-complications
    Description
    subjective symptoms
    Time Frame
    one-year follow up

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: focal maculopathy diffuse macular edema diffuse macular edema with ischemic changes Exclusion Criteria: ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula patients with history of stroke or transient ischemic attack hypersensitivity to ranibizumab or any component of the ranibizumab formulation uncontrolled glaucoma in either eye (intraocular pressure [IOP] >24 mmHg with medication) evidence of vitreomacular traction (in either eye) active proliferative diabetic retinopathy (study eye)

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data processed and saved in eye center in the college

    Learn more about this trial

    New Concepts in Diabetic Macular Edema (DME)

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