Variable Interval Versus Set Interval Aflibercept for DME

Completed · Phase 4

Conditions studied: Cystoid Macular Edema, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT02392364

Run by

California Retina Consultants

People needed

50

Starts

2015-04-15

Expected to finish

2018-11-15

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years and older with Type 1 or Type 2 diabetes mellitus
• 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)
• Decrease in vision determined to be primarily due to DME in the study eye
• BCVA ETDRS letter score 78 to 24 (20/32 to 20/320) in the study eye
• Willing and able to comply with clinical visits and study related procedures
• Willing and able to provide signed informed consent

You may not qualify if…

• History of vitreoretinal surgery in the study eye
• Laser photocoagulation (panretinal or macular) in the study eye within 90 days of baseline
• Previous use of intraocular or periocular corticosteroids in the study eye within 90 days of baseline
• History of intravitreal anti-VEGF treatments in the study within 90days prior to baseline (not including prior intravitreal aflibercept injection [see exclusion criteria #5])
• Any history of intravitreal aflibercept
• Active proliferative diabetic retinopathy (PDR) in the study eye
• History of idiopathic or autoimmune uveitis in the study eye
• Cataract surgery in the study eye within 90 days of baseline
• Aphakia in the study eye
• Yttrium aluminum garnet (YAG) capsulotomy in the study eye within 30 days of baseline
• Any intraocular surgery in the study eye within 90 days of day 1
• Vitreomacular traction or epiretinal membrane in the study eye that is thought to affect central vision
• Current iris neovascularization, vitreous hemorrhage, or traction retinal detachment in the study eye
• Pre-retinal fibrosis involving the macula in the study eye
• 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)
• Myopia of a spherical equivalent prior to any possible refractive or cataract surgery of ≥-8 diopters
• 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)
• Ocular media of insufficient quality to obtain fundus and SDOCT images
• Current treatment for a systemic infection
• Administration of systemic anti-angiogenic agents within 180 days of baseline
• Uncontrolled diabetes mellitus, in the opinion of the investigator
• Uncontrolled blood pressure (define as systolic >180mmHg, or diastolic >110mmHg while patient is sitting)
• History of CVA or MI within 180 days of baseline
• Renal failure requiring dialysis or renal transplant
• Known serious allergy to fluorescein

Where it is running

• California Retina Consultants - Bakersfield — Bakersfield, California, United States
• California Retina Consultants - Santa Barbara Office — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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