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Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

Primary Purpose

Retinal Diseases

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ranibizumab
Aflibercept
Ranibizumab and Aflibercept
Aflibercept and ranibizumab
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Diseases focused on measuring diabetic macular edema, aflibercept, ranibizumab

Eligibility Criteria

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

Inclusion Criteria:

  • patients with Diabetic macular edema

Exclusion Criteria:

  • patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Ranibizumab

    Aflibercept

    Ranibizumab and Aflibercept

    Aflibercept and Ranibizumab

    Arm Description

    - In the first group will be held three applications of intravitreal ranibizumab 0.1 ml . This group will be five about patients about any age, with diabetic macular edema randomly chosen

    - In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml. This group will be about five patients about any age, with diabetic macular edema randomly chosen

    - In this group will be held two applications of 0.1 ml Aflibercept(the first and the third doses) interspersed with one application of Ranibizumab 0.1 ml(the second dose). This group will be about five patients about any age, with diabetic macular edema randomly chosen

    - This group will be held two applications of Ranibizumab 0.1 ml(the first and the third doses) interspersed with one application of Aflibercept 0.1 ml(the second dose). This group will be five about patients about any age, with diabetic macular edema randomly chosen

    Outcomes

    Primary Outcome Measures

    Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema
    Were evaluated the therapy with two different drugs used in diabetic retinopathy, and for this were separated twenty patients in four groups: First group will be held three applications of intravitreal ranibizumab 0.1 ml, and follow up with OCT. Second group will be held three applications of Intravitreal Aflibercept 0.1 ml, and followed by monitoring with OCT. Third group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with OCT. Fourth group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with OCT. In all this groups will be observe the time of reduction of macular edema in the days 1, 3, 5, 10 and 30.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 2, 2015
    Last Updated
    January 3, 2016
    Sponsor
    Instituto de Olhos de Goiania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02646670
    Brief Title
    Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
    Official Title
    Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    October 2015 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Olhos de Goiania

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study in to compare the efficacy of treatment of diabetic macular edema (DME) using Ranibizumab (Lucenti®), Aflibercept (Eylea®) and Aflibercept (Eylea®) plus Ranibizumab (Lucentis®). It is a randomized clinical trial that will evaluate the efficacy of the combination of two substances currently used in the treatment of DME. Will be allocated in different four groups randomly pacients who receive treatment with intravitreal injections of ranibizumab, aflibercept or a combination of aflibercept and ranibizumab.
    Detailed Description
    Interventions will be carried out with intravitreal injections in patients with formal indications of diabetic macular edema treatment previously assessed with complete eye examination in Goiania Eye Institute(Instituto de Olhos de Goiânia) Patients will be divided into four groups: In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 following the application. In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography on days 1, 3, 5, 10 and 30 subsequent The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30. In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography on days 1, 3, 5, 10 and 30.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Diseases
    Keywords
    diabetic macular edema, aflibercept, ranibizumab

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ranibizumab
    Arm Type
    Active Comparator
    Arm Description
    - In the first group will be held three applications of intravitreal ranibizumab 0.1 ml . This group will be five about patients about any age, with diabetic macular edema randomly chosen
    Arm Title
    Aflibercept
    Arm Type
    Active Comparator
    Arm Description
    - In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml. This group will be about five patients about any age, with diabetic macular edema randomly chosen
    Arm Title
    Ranibizumab and Aflibercept
    Arm Type
    Active Comparator
    Arm Description
    - In this group will be held two applications of 0.1 ml Aflibercept(the first and the third doses) interspersed with one application of Ranibizumab 0.1 ml(the second dose). This group will be about five patients about any age, with diabetic macular edema randomly chosen
    Arm Title
    Aflibercept and Ranibizumab
    Arm Type
    Active Comparator
    Arm Description
    - This group will be held two applications of Ranibizumab 0.1 ml(the first and the third doses) interspersed with one application of Aflibercept 0.1 ml(the second dose). This group will be five about patients about any age, with diabetic macular edema randomly chosen
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab
    Intervention Description
    - In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept
    Intervention Description
    - In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography
    Intervention Type
    Drug
    Intervention Name(s)
    Ranibizumab and Aflibercept
    Intervention Description
    - The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept and ranibizumab
    Intervention Description
    - In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography
    Primary Outcome Measure Information:
    Title
    Efficacy of Ranibizumab Therapy with Aflibercept in Patients with Diabetic Macular Edema
    Description
    Were evaluated the therapy with two different drugs used in diabetic retinopathy, and for this were separated twenty patients in four groups: First group will be held three applications of intravitreal ranibizumab 0.1 ml, and follow up with OCT. Second group will be held three applications of Intravitreal Aflibercept 0.1 ml, and followed by monitoring with OCT. Third group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with OCT. Fourth group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with OCT. In all this groups will be observe the time of reduction of macular edema in the days 1, 3, 5, 10 and 30.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with Diabetic macular edema Exclusion Criteria: patients without diabetic macular edema, or with diabetic macular edema with other disease that can make confuse about the diagnose

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Ranibizumab Therapy With Aflibercept in Patients With Diabetic Macular Edema

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