Mean Visual Acuity Changes Following Five Injections of Aflibercept

Sponsor
McMaster University
Study ID
NCT02645266
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aflibercept Injection [Eylea] — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 1, 2018
Status verified
Nov 2024
Primary completion
Sep 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept Injection [Eylea] group
    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.

Primary Outcome Measure

To determine change in BCVA from baseline to month 5 of aflibercept treatment [ Time Frame: 5 months ]

Related Studies