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Monoclonal Antibodies
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
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
Find a Location
Who is running the clinical trial?
McMaster UniversityLead Sponsor
918 Previous Clinical Trials
2,616,245 Total Patients Enrolled
Media Library
Awards:
This trial has 2 awards, including:- 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.