A Phase 4 interventional study of aflibercept in Diabetic Macular Edema, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Treatment
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.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 16 is below the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
aflibercept, 40 mg/mL Solution for Intravitreal Injection
Drug: aflibercept
Also known as: Eylea
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months
Time frame: 3 months
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept
Time frame: 3 months
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Unity Health Toronto