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

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: aflibercept

• Registration Number: NCT02441907
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-12
• Study Start: 2015-08
• Primary Completion: 2018-08
• Status Verified: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
aflibercept treatment	aflibercept	aflibercept, 40 mg/mL Solution for Intravitreal Injection

Primary Outcome Measures

Name	Time	Method
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months	3 months

Secondary Outcome Measures

Name	Time	Method
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept	3 months

Trial Locations

Locations (1)

St. Michael's Hospital Eye Clinic; 🇨🇦 Toronto, Ontario, Canada