Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema

Sponsor
Unity Health Toronto
Study ID
NCT02441907
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. However, response in patients to these anti-VEGF drugs can vary and examination of predictive factors is required. This particular study examines cellular factors called cytokines in patients receiving aflibercept, a type of anti-VEGF drug, in the hopes of detecting changes in cytokines that can predict treatment response amongst groups of patients.

Key Dates

Start date
Aug 31, 2015
Status verified
Sep 2019
Primary completion
Aug 31, 2018
Completion
Sep 30, 2019

Study Design

Enrollment
16 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: aflibercept treatment
    aflibercept, 40 mg/mL Solution for Intravitreal Injection

Primary Outcome Measure

Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months [ Time Frame: 3 months ]

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