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The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Subconjunctival bevacizumab (Altuzan)
Sponsored by
Neon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having diffuse diabetic macular edema persisted at least 1 month
  • No intravitreal injection in last 3 months.
  • No retinal laser photocoagulation in last 6 months
  • Not have any other macular disease causing macular edema

Exclusion Criteria:

  • Having ischemic macula
  • Intravitreal injection in last 3 months.
  • Retinal laser photocoagulation in last 6 months
  • Have any other macular disease causing macular edema

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Diabetic macular edema

    Arm Description

    Bevacizumab (Altuzan) was injected subconjunctival space of the patients.

    Outcomes

    Primary Outcome Measures

    Central Macular Thickness

    Secondary Outcome Measures

    Full Information

    First Posted
    June 7, 2016
    Last Updated
    June 9, 2016
    Sponsor
    Neon Hospital
    Collaborators
    Ondokuz Mayıs University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02796183
    Brief Title
    The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
    Official Title
    The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Neon Hospital
    Collaborators
    Ondokuz Mayıs University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.
    Detailed Description
    At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diabetic macular edema
    Arm Type
    Other
    Arm Description
    Bevacizumab (Altuzan) was injected subconjunctival space of the patients.
    Intervention Type
    Drug
    Intervention Name(s)
    Subconjunctival bevacizumab (Altuzan)
    Intervention Description
    Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.
    Primary Outcome Measure Information:
    Title
    Central Macular Thickness
    Time Frame
    one year (between May 2015 and May 2016)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having diffuse diabetic macular edema persisted at least 1 month No intravitreal injection in last 3 months. No retinal laser photocoagulation in last 6 months Not have any other macular disease causing macular edema Exclusion Criteria: Having ischemic macula Intravitreal injection in last 3 months. Retinal laser photocoagulation in last 6 months Have any other macular disease causing macular edema

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

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