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Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema (Endurance3)

Primary Purpose

Clinically Significant Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Assigned Intervention
aflibercept 2.0 mg
Sponsored by
Retina-Vitreous Associates Medical Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clinically Significant Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

  • Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent
  • Enrollment in the trial within 12 weeks of trial activation

Exclusion Criteria:

  • Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
  • Pregnant or breast-feeding women
  • Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Open-Label Arm

    Arm Description

    2mg Aflibercept, as needed, intravitreal administration. All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed. If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks. At week 12 through end of study, all subjects will be evaluated for focal laser treatment.

    Outcomes

    Primary Outcome Measures

    Mean number of intravitreal aflibercept injections in 52 weeks
    Proportion of subjects receiving 0 aflibercept injections in 52 weeks
    Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
    Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events

    Secondary Outcome Measures

    Vision Change
    Mean change in visual acuity from baseline to week 52
    Vision loss
    Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52
    Change in central retinal thickness
    Mean change in central retinal thickness from baseline to week 52
    Development of clinically relevant diabetic macular edema
    Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52
    Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)
    Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging
    Role of focal laser treatment in management of DME (Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment)
    Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment
    Ocular and systemic adverse events
    Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting

    Full Information

    First Posted
    December 16, 2014
    Last Updated
    March 25, 2019
    Sponsor
    Retina-Vitreous Associates Medical Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02734407
    Brief Title
    Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema
    Acronym
    Endurance3
    Official Title
    Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    September 27, 2017 (Actual)
    Study Completion Date
    September 27, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Retina-Vitreous Associates Medical Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The Endurance Trial is a Phase IV open label clinical study to assess the need for ongoing intravitreal aflibercept injections after the 3-year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) based on the presence of CR-DME (Clinically Relevant-DME). In addition, subjects who meet re-treatment criteria will be eligible for focal laser treatment every 90 days
    Detailed Description
    The Endurance3 Trial is a Phase IV open label study to assess the need for ongoing intravitreal aflibercept injections after the 3 year VISTA DME (VGFT-OD-1009) endpoint. Subjects will be treated with intravitreal aflibercept injections pro re nata (PRN) upon the presence of CR-DME (Clinically Relevant DME) as noted by OCT (Optical Coherence Tomography) imaging and examination. In addition, subjects who meet the re-treatment criteria will be eligible for focal laser treatment every 90 days.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Open-Label Arm
    Arm Type
    Experimental
    Arm Description
    2mg Aflibercept, as needed, intravitreal administration. All subjects will be treated with intravitreal (IVT) aflibercept injections as needed in the presence of clinically relevant diabetic macular edema (CR-DME). If CR-DME is not present the subject will not receive an IVT aflibercept injection and will be observed. If a subject has recurrent CR-DME they will receive an IVT aflibercept 2.0 mg injection and interval between visits will be reduced to 4 weeks. At week 12 through end of study, all subjects will be evaluated for focal laser treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Assigned Intervention
    Other Intervention Name(s)
    FLT
    Intervention Description
    All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study as assigned intervention. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.
    Intervention Type
    Drug
    Intervention Name(s)
    aflibercept 2.0 mg
    Other Intervention Name(s)
    Eylea, VEGF-Trap
    Intervention Description
    If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
    Primary Outcome Measure Information:
    Title
    Mean number of intravitreal aflibercept injections in 52 weeks
    Time Frame
    12 months
    Title
    Proportion of subjects receiving 0 aflibercept injections in 52 weeks
    Time Frame
    12 months
    Title
    Longer-term efficacy of aflibercept intravitreal injections as assessed by the mean number of injections in 52 weeks
    Time Frame
    12 months
    Title
    Safety of ongoing aflibercept intravitreal injections as assessed by the incidence and severity of ocular and systemic adverse events
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Vision Change
    Description
    Mean change in visual acuity from baseline to week 52
    Time Frame
    12 months
    Title
    Vision loss
    Description
    Proportion of subjects with gain or loss of 0 to 5 letters from baseline to week 52
    Time Frame
    12 months
    Title
    Change in central retinal thickness
    Description
    Mean change in central retinal thickness from baseline to week 52
    Time Frame
    12 months
    Title
    Development of clinically relevant diabetic macular edema
    Description
    Percentage of subjects with no clinically relevant diabetic macular edema seen on SD-OCT from baseline to week 52
    Time Frame
    12 months
    Title
    Evaluation of Diabetic Retinopathy (Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging)
    Description
    Proportion of subjects with stable, worsened, or improved diabetic retinopathy as identified by eye examination and imaging
    Time Frame
    12 months
    Title
    Role of focal laser treatment in management of DME (Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment)
    Description
    Proportion of subjects that receive focal laser treatment and mean number of intravitreal aflibercept injections before and after receiving focal laser treatment
    Time Frame
    12 months
    Title
    Ocular and systemic adverse events
    Description
    Incidence and severity of ocular and systemic adverse events as identified by eye examinations, imaging, and subject reporting
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Enrolled and completed VISTA DME (VGFT-OD-1009) clinical trial Willing and able to comply with clinic visits and study-related procedures Provide signed informed consent Enrollment in the trial within 12 weeks of trial activation Exclusion Criteria: Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline Pregnant or breast-feeding women Sexually active ment or women of childbearing potential who are unwilling to practice adequate contraception during the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Boyer, MD
    Organizational Affiliation
    Retina-Vitreous Associates Medical Group
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Long-Term Efficacy and Safety of Aflibercept Intravitreal Injections for the Treatment of Diabetic Macular Edema

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