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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
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema

Eligible Conditions
  • Diabetic Macular Edema

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 24 weeks, 36 weeks, and 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 24 weeks, 36 weeks, and 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central Subfield Thickness (CST)
Secondary study objectives
Best Corrected Visual Acuity (BCVA)
CST
Monthly mean changes from baseline in BCVA
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
Dexamethasone
FDA approved
Aflibercept
FDA approved

Find a Location

Who is running the clinical trial?

The Emmes Company, LLCIndustry Sponsor
147 Previous Clinical Trials
1,052,110 Total Patients Enrolled
Texas Retina AssociatesLead Sponsor
5 Previous Clinical Trials
230 Total Patients Enrolled
Ashkan M Abbey, MDPrincipal InvestigatorTexas Retina Associates
~8 spots leftby Nov 2025
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