The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial (COED Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAshkan M Abbey, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Texas Retina Associates

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Ashkan M Abbey, MD

Principal Investigator

Texas Retina Associates

Eligibility Criteria

Inclusion Criteria

Type 1 or 2 diabetic patients

At least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent before any study procedures

Pseudophakic or phakic lens status with intact posterior lens capsule and/or Nd:YAG laser capsulotomy that in the investigator's opinion is not likely to permit dislocation of Ozurdex implant into the anterior chamber

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Treatment Details

Interventions

Eylea (Monoclonal Antibodies)
Ozurdex (Corticosteroid)

Participant Groups

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)