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Long-Term Efficacy & Safety of Aflibercept IVT for the Treatment of DME in Subjects Who Completed the VISTA-DME Trial

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ClinicalTrials.gov Identifier: NCT02299336
Recruitment Status : Completed
First Posted : November 24, 2014
Results First Posted : June 7, 2018
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Charles C Wykoff, PhD, MD, Greater Houston Retina Research

Study Description
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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; NCT01363440) end-point. 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aflibercept Procedure: Focal Laser Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema in Subjects Who Completed the Three Year VISTA-DME Trial .
Actual Study Start Date : November 24, 2014
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
PRN (pro re nata)
2 mg intravitreal aflibercept (Eylea) PRN, focal laser administered based on pre-specified criteria, 104 weeks
 Drug: Aflibercept
pro re nata (PRN)
Other Name: Eylea

Procedure: Focal Laser
Focal laser administered based on pre-specified criteria


Outcome Measures
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Primary Outcome Measures :
  1. Mean Number of Intravitreal Aflibercept Injections for Subjects Who Were Enrolled and Completed the 3-year VISTA DME (VGFT-OD-1009) Trial [ Time Frame: Week 104 ]
    Measured by evaluating mean number of injections required for subjects who were enrolled and completed the 3-year VISTA DME (VGFT-OD-1009) trial


Secondary Outcome Measures :
  1. Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity From Baseline to Week 52 and Baseline to Week 104 [ Time Frame: Week 52, Week 104 ]
    Evaluate the mean change over time in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity at week 52 from baseline and at week 104 from baseline. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.

  2. Mean Number of Intravitreal Aflibercept Injections Before and After Receiving First Focal Laser Application. [ Time Frame: Before First Focal Laser Treatment (FLT) at Week 12 or later; After First FLT at up to 104 weeks ]
    Measure the role of focal laser treatment (fluorescein angiography-guided, if applicable) in decreasing the treatment burden among subjects who require ongoing aflibercept treatment in the management of diabetic macular edema.

  3. Percentage of Subjects With Gain or Loss of 0 to 5 Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Letters From Baseline to Week 52 and Baseline to Week 104 [ Time Frame: Week 52, Week 104 ]
    Evaluate the percentage of subjects with a gain or loss in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letters in patients treated with aflibercept from baseline to week 52 and baseline to week 104

  4. Mean Change in Central Retinal Thickness From Baseline to Week 52 and Baseline to Week 104. [ Time Frame: Week 52, Week 104 ]
    Evaluate the mean change in central retinal thickness from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.

  5. Number of Subjects With no Clinically-relevant Diabetic Macular Edema (as Defined in the Protocol) on Spectral Domain Optical Coherence Tomography From Baseline to Week 52 and Baseline to Week 104. [ Time Frame: Week 52, Week 104 ]
    Evaluate the number of subjects with no clinically-relevant diabetic macular edema (as defined in the protocol) on spectral domain optical coherence tomography from baseline to week 52 and baseline to week 104 in patients treated with aflibercept.

  6. Number of Subjects With Stable, Worsened, or Improved Diabetic Retinopathy [ Time Frame: Week 52, Week 104 ]
    Number of subjects with stable, worsened, or improved diabetic retinopathy through 104 weeks.

  7. Number of Subjects That Receive Focal Laser Treatment. [ Time Frame: Week 52, Week 104 ]
    Number of subjects that receive focal laser treatment from baseline to week 52 and from baseline to week 104.

  8. Mean Change in Early Treatment Diabetic Retinopathy Study Best-corrected Visual Acuity Before and After Focal Laser Therapy [ Time Frame: 104 weeks ]
    Evaluation of the effect of laser on Early Treatment Diabetic Retinopathy Study best-corrected visual acuity outcomes. Participants were challenged with reading letters on lines of an eye chart (5 letters per line) in standardized lighting conditions. Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.

  9. Mean Change in Central Retinal Thickness Before and After First Focal Laser Treatment [ Time Frame: 104 weeks ]
    Evaluate the mean change in central retinal thickness before and after first focal laser treatment in patients treated with pro re nata aflibercept.

  10. Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Past and Future Anti-VEGF Treatment Burden [ Time Frame: Week 52, Week 104 ]
    Mean number of injections in 52 weeks and 104 weeks based on quantification of ischemic areas

  11. Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Visual Outcomes [ Time Frame: Week 52, Week 104 ]
    Mean change in visual acuity from baseline to week 52 and baseline to week 104 based on quantification of ischemic areas

  12. Role of (Ultrawide-field, if Available) Fluorescein Angiography-determined Retinal Ischemia in Predicting Anatomic Outcomes [ Time Frame: Week 52, Week 104 ]
    Mean change in central retinal thickness from baseline to week 52 based on quantification of ischemic areas


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A subject must meet the following criteria to be eligible for inclusion in the study:

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

Exclusion Criteria:

  • A subject who meets any of the following criteria will be excluded from the study:

    1. Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline
    2. Pregnant or breast-feeding women

    3. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly).

      • Contraception is not required for men with documented vasectomy. **Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299336


Locations
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United States, Texas
Retina Consultants of Houston/The Medical Center
Houston, Texas, United States, 77030
Retina Consultants of Houston/Katy office
Katy, Texas, United States, 77494
Retina Consultants of Houston
The Woodlands, Texas, United States, 77384
Sponsors and Collaborators
Greater Houston Retina Research
Regeneron Pharmaceuticals
Investigators
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Principal Investigator: Charles C Wykoff, MD Greater Houston Retina Research
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Charles C Wykoff, PhD, MD, Principal Investigator, Greater Houston Retina Research
ClinicalTrials.gov Identifier: NCT02299336     History of Changes
Other Study ID Numbers: The Endurance 1 Trial
First Posted: November 24, 2014    Key Record Dates
Results First Posted: June 7, 2018
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases