MedTrace Logo

Ozurdex in Suboptimal Diabetic Macular Edema Patients

NCT04856397 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-05-12

No results posted yet for this study

Summary

The primary focus of this study is to understand the anatomic and visual outcomes of patients with refractory and suboptimal treatment response diabetic macular edema (DME) using anti-vascular endothelial growth factor (VEGF) to Ozurdex, an intravitreal dexamethasone implant. Secondly, investigators aim to understand the differences in cytokine profiles in patients who respond differently to intravitreal anti-VEGF versus Ozurdex. The importance of this study is to identify biomarkers that may help predict patients' response to different treatment protocols. Currently, Ozurdex is not covered by provincial health benefit plans for patients with DME. Our results may help improve access to care for those who have suboptimal results with or refractory to intravitreal anti-VEGF treatment.

Conditions

Interventions

DRUG

Intravitreal Implant in Applicator

Dexamethasone intravitreal implant

DRUG

Eylea

anti-VEGF medication

Sponsors & Collaborators

  • Uptown Eye Specialists

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-25
Primary Completion
2021-08-30
Completion
2021-12-29

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04856397 on ClinicalTrials.gov