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Monoclonal Antibodies
Combination of Ozurdex and Eylea for Diabetic Macular Edema
Phase 4
Recruiting
Led By Ashkan M Abbey, MD
Research Sponsored by Texas Retina Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Awards & highlights
Study Summary
The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)
Eligible Conditions
- Diabetic Macular Edema
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 24 weeks, 36 weeks, and 48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Central Subfield Thickness (CST)
Secondary outcome measures
Best Corrected Visual Acuity (BCVA)
CST
Monthly mean changes from baseline in BCVA
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Combination of Ozurdex and EyleaExperimental Treatment2 Interventions
Eyes receiving intravitreal injection of Ozurdex every 3 months (as needed per protocol) and intravitreal injection of Eylea every month (as needed per protocol)
Group II: Eylea MonotherapyActive Control1 Intervention
Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
The Emmes Company, LLCIndustry Sponsor
145 Previous Clinical Trials
1,051,441 Total Patients Enrolled
Texas Retina AssociatesLead Sponsor
5 Previous Clinical Trials
230 Total Patients Enrolled
Ashkan M Abbey, MDPrincipal InvestigatorTexas Retina Associates
Frequently Asked Questions
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