Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, Ocular Cytokines, Triamcinolone Acetonide
Brief 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.
Interventions
DRUGaflibercept
Sponsors
Unity Health Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged 18 years or above * Presence of Non Proliferative Diabetic Retinopathy (NPDR) * Treatment Naïve patients with DME with central macular thickness of 310μm or more on SD-OCT (cirrus) * Subjects with Type I or II diabetes mellitis * Willing and able to provide informed consent for participation in the study
Exclusion criteria
* Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months * Uncontrolled glaucoma * History of intraocular surgery within 3 months in the study eye * History of vitrectomy surgery * Laser treatment within 3 months of study eye * Vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye * Prior intravitreal injection within the past 6 months * Known allergy to the study drug or fluorescein * History of stroke or AMI within 6 months of enrollment * Patients receiving dialysis for renal failure * Patients currently on systemic immunosuppression * Patients on two or more class of medication for glaucoma in study eye * Patients with tuberculosis * Patients who are pregnant. * Unwilling or unable to follow or comply with all study related procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept | 3 months |
Countries
Canada
Outcome results
None listed