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Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sub-macular injection of Ranibizumab
Sponsored by
University of Alexandria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

  • refractory diffuse non tractional DME.
  • Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy.
  • Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5.

Exclusion Criteria:

  • Previous vitrectomy, recent cataract surgery less than 6 months,
  • evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT,
  • glaucoma and one eyed patients.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Persistent Diabetic macular edema

    Arm Description

    Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections.

    Outcomes

    Primary Outcome Measures

    The primary endpoint for this study was the change in CMT at the final visit.
    Central macular thickness

    Secondary Outcome Measures

    Full Information

    First Posted
    June 2, 2019
    Last Updated
    June 3, 2019
    Sponsor
    University of Alexandria
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03975088
    Brief Title
    Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
    Official Title
    Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    The best treatment strategy for refractory DME is not known, options include switching between anti-VEGF agents, corticosteroids, and vitrectomy. In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
    Detailed Description
    Purpose: In this study, authors describe a new surgical technique for the treatment of refractory DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab. Methods: This is a prospective interventional non-comparative study including patients with refractory DME. Included patients were subjected to the new surgical technique of pars plana vitrectomy with sub-retinal injection of Ranibizumab.

    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
    19 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Persistent Diabetic macular edema
    Arm Type
    Other
    Arm Description
    Authors defined refractory DME as eyes with persistent DME despite receiving at least 6 monthly Ranibizumab injections of anti VEGF, and then switched to Aflibercept, receiving at least three monthly injections.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sub-macular injection of Ranibizumab
    Intervention Description
    In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
    Primary Outcome Measure Information:
    Title
    The primary endpoint for this study was the change in CMT at the final visit.
    Description
    Central macular thickness
    Time Frame
    at the 6 month follow up visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: refractory diffuse non tractional DME. Central retinal thickness (CRT) should exceed 350 µm despite undergoing multiple anti-VEGF therapy. Decimal best corrected visual acuity (BCVA) must be ≥0.01 and ≤0.5. Exclusion Criteria: Previous vitrectomy, recent cataract surgery less than 6 months, evident RPE atrophy, proliferative diabetic retinopathy, massive foveal hard exudation, foveal traction on OCT, glaucoma and one eyed patients.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    proecting patient privacy
    Citations:
    PubMed Identifier
    31772766
    Citation
    El-Baha SM, Abdel Hadi AM, Abouhussein MA. Submacular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema. J Ophthalmol. 2019 Oct 21;2019:6274209. doi: 10.1155/2019/6274209. eCollection 2019.
    Results Reference
    derived

    Learn more about this trial

    Sub-macular Injection of Ranibizumab as a New Surgical Treatment for Refractory Diabetic Macular Edema

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