Cystoid Macular Edema, Diabetic Macular Edema
Conditions
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.
Interventions
Sponsors
Regeneron Pharmaceuticals
California Retina Consultants
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BCVA Change | Week 0 to Week 52 | Change in mean BCVA from baseline to week 52 |
Countries
United States
Outcome results
None listed