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ACTIVE NOT RECRUITING
NCT02645266
NA

Mean Visual Acuity Changes Following Five Injections of Aflibercept

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

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.

Official title: Mean Visual Acuity Changes Following Five Injections of Aflibercept and the Relationship Between Ocular and Serum Cytokine Levels and Mean Visual Acuity Gains in DME Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2018-05-01

Completion Date

2025-12

Last Updated

2024-11-25

Healthy Volunteers

Yes

Interventions

DRUG

Aflibercept Injection [Eylea]

Subjects will be administered 2.0mg Aflibercept intraocular injection each month for 5 consecutive months. After the 5th month, the serum cytokine levels in blood work will be assessed as well as patients's visual acuity, and eye pressures. Upon completion of the trial, patients will resume receiving the usual standard of care.

Locations (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada