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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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292

Retinal detachment

Myelodysplastic syndrome

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

IAI 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

886 Previous Clinical Trials

2,598,424 Total Patients Enrolled

Media Library

Diabetic Macular Edema Clinical Trial 2023: Aflibercept Highlights & Side Effects. Trial Name: NCT02645266 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what maladies is Aflibercept Injection [Eylea] typically prescribed?

"Aflibercept Injection [Eylea] is a powerful therapeutic option for tackling age-related macular degeneration (wamd), dealing with macular edema, and alleviating diabetic macular edema."

Answered by AI

Is enrollment for this experiment ongoing?

"Correct. According to information published on clinicaltrials.gov, this study is actively seeking patients to enroll. This medical trial was initially posted on May 1st 2018 and has since been updated as of March 15th 2023; 48 subjects are required from a single research site."

Answered by AI

How many volunteers are engaged in this medical experiment?

"Affirmative. The information hosted on clinicaltrials.gov suggests that this study, which was first advertised in May 2018, is presently accepting enrollees for participation. A total of 48 individuals are needed from a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mean Visual Acuity Changes Following Five Injections of Aflibercept

2018. "Mean Visual Acuity Changes Following Five Injections of Aflibercept". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02645266.

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