Aflibercept Injections for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: McMaster University

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Diabetic Macular Edema is a serious ocular consequence of poorly controlled diabetes. Even though significant research has been done to clarify the pathogenesis of DME, a clear causal pathway of the complication is of yet undetermined. However, there is some consensus among researchers that a cascade of inflammatory markers plays an important role in the disease process. The study hopes to better delineate the role these inflammatory markers play by investigating whether basal levels predict response or lack thereof to Aflibercept.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Diagnosis of DME by a retina specialist

Age: 18 or older

VA between 25 and 75 letters at baseline

See 1 more

Exclusion Criteria

Previous anti-VEGF intravitreal treatment in affected eye

Previous laser treatment for DME within last 3 months

Any ocular surgery within the last 3 months

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Treatment Details

Interventions

Aflibercept (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.