Aflibercept Injections for Diabetic Macular Edema

N/A

Waitlist Available

Research Sponsored by McMaster University

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 5 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will research if inflammation markers can predict a response to a treatment for Diabetic Macular Edema, a serious eye complication caused by diabetes.

Who is the study for?

This trial is for adults diagnosed with Diabetic Macular Edema (DME) by a retina specialist, who have not received prior treatments like anti-VEGF injections or laser treatment for DME in the last three months. Participants should have a visual acuity score between 25 and 75 letters and must be willing to sign a consent form.

What is being tested?

The study tests Aflibercept injections [Eylea] on patients with DME to see if levels of inflammatory markers before treatment can predict how well they'll respond. The goal is to understand better the role inflammation plays in DME.

What are the potential side effects?

Aflibercept may cause eye-related side effects such as redness, pain at the injection site, blurred vision, cataracts, and possibly an increased risk of eye infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine change in BCVA from baseline to month 5 of aflibercept treatment

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.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aflibercept Injection [Eylea] groupExperimental Treatment1 Intervention

Intervention: Subjects will be receiving a (2mg/ml) dose of VEGF-Trap, injected intravitreally at the start of every month, for the 4 months duration of the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aflibercept

FDA approved

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