EVADE: Variable Interval Versus Set Interval Aflibercept for DME

Sponsor
California Retina Consultants (Other)
Overall Status
Completed
CT.gov ID
NCT02392364
Collaborator
Regeneron Pharmaceuticals (Industry)
50
2
2
43
25
0.6

Study Details

Study Description

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
  • Drug: Intravitreal Aflibercept Injection
Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 15, 2015
Actual Primary Completion Date :
Nov 15, 2018
Actual Study Completion Date :
Nov 15, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. BCVA Change [Week 0 to Week 52]

    Change in mean BCVA from baseline to week 52

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 California Retina Consultants - Bakersfield Bakersfield California United States 93039
2 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
California Retina Consultants
ClinicalTrials.gov Identifier:
NCT02392364
Other Study ID Numbers:
  • 2014-01-CRC
First Posted:
Mar 19, 2015
Last Update Posted:
Jan 3, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 3, 2019