drugset / Trial / NCT02441907

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

NCT02441907

Phase 4 Completed 16 enrolled Unity Health Toronto
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2015-08
Primary completion
2018-08
Completion
2019-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 40 mg/ml Intravitreal