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Variable Interval Versus Set Interval Aflibercept for DME (EVADE)

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ClinicalTrials.gov Identifier: NCT02392364
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
California Retina Consultants

Brief Summary:
The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule (likely longer than one month), based on a specific individual's disease progression. There will be approximately 50 men and women at least 18 years of age, diagnosed with type 1 or type 2 diabetes, taking part in this study at 5 locations in the United States.

Condition or disease Intervention/treatment Phase
Cystoid Macular Edema Diabetic Macular Edema Drug: Intravitreal Aflibercept Injection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treat and Extend Versus Dosing Every Eight Weeks With Intravitreal Aflibercept Injections for the Treatment of Diabetic Macular Edema (EVADE Study)
Actual Study Start Date : April 15, 2015
Actual Primary Completion Date : November 15, 2018
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Variable Treatment Dosing Arm
Group 1 will receive injections every 4 weeks until diabetic macular edema on the OCT is decreased and stable. At that point, the length of time between injections may increase, depending on how the study eye is doing. The interval between study eye treatments may maintain, increase, or decrease once the variable treatment dosing has begun. This will be determined by an algorithm designed into a computer program
Drug: Intravitreal Aflibercept Injection
Active Comparator: Monthly Treatment Arm
Group 2 will receive 5 intravitreal injections, monthly, for the first 5 months of the study. After those initial injections, visits/treatment will be every 8 weeks.
Drug: Intravitreal Aflibercept Injection



Primary Outcome Measures :
  1. BCVA Change [ Time Frame: Week 0 to Week 52 ]
    Change in mean BCVA from baseline to week 52



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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:

  1. Adults 18 years and older with Type 1 or Type 2 diabetes mellitus
  2. Patients with diabetic macular edema involving the center of the macular in the study eye (CST must measure at least 350µm on Heidelberg SDOCT, or 333µm on Cirrus SDOCT)
  3. Decrease in vision determined to be primarily due to DME in the study eye
  4. BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye
  5. Willing and able to comply with clinical visits and study related procedures
  6. Willing and able to provide signed informed consent

Exclusion Criteria:

  1. History of vitreoretinal surgery in the study eye
  2. Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline
  3. Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline
  4. History of intravitreal anti-VEGF treatments in the study within 90days prior to baseline (not including prior intravitreal aflibercept injection [see exclusion criteria #5])
  5. Any history of intravitreal aflibercept
  6. Active proliferative diabetic retinopathy (PDR) in the study eye
  7. History of idiopathic or autoimmune uveitis in the study eye
  8. Cataract surgery in the study eye within 90 days of baseline
  9. Aphakia in the study eye
  10. Yttrium aluminum garnet (YAG) capsulotomy in the study eye within 30 days of baseline
  11. Any intraocular surgery in the study eye within 90 days of day 1
  12. Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect central vision
  13. Current iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the study eye
  14. Pre-retinal fibrosis involving the macula in the study eye
  15. Uncontrolled glaucoma (defined as any patient who has had filtration surgery in the past, or likely to need filtration surgery in the future, or has IOP ≥30mmHg)
  16. Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥-8 diopters
  17. Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
  18. Ocular media of insufficient quality to obtain fundus and SDOCT images
  19. Current treatment for a systemic infection
  20. Administration of systemic anti-angiogenic agents within 180 days of baseline
  21. Uncontrolled diabetes mellitus, in the opinion of the investigator
  22. Uncontrolled blood pressure (define as systolic >180mmHg, or diastolic >110mmHg while patient is sitting)
  23. History of CVA or MI within 180 days of baseline
  24. Renal failure requiring dialysis or renal transplant
  25. Known serious allergy to fluorescein
  26. Participation in an investigational study within 30 days prior to baseline that involved treatment with any drug (excluding vitamins and minerals) or device
  27. Any women who are pregnant, breast-feeding, or attempting to become pregnant
  28. 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.

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): NCT02392364


Locations
United States, California
California Retina Consultants - Bakersfield
Bakersfield, California, United States, 93039
California Retina Consultants - Santa Barbara Office
Santa Barbara, California, United States, 93103
Sponsors and Collaborators
California Retina Consultants
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Dilsher S Dhoot, MD California Retina Consultants

Responsible Party: California Retina Consultants
ClinicalTrials.gov Identifier: NCT02392364     History of Changes
Other Study ID Numbers: 2014-01-CRC
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases