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

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT02441907

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: aflibercept	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: aflibercept treatment aflibercept, 40 mg/mL Solution for Intravitreal Injection	Drug: aflibercept Other Names: Eylea

Arm

Intervention/Treatment

Other: aflibercept treatment

aflibercept, 40 mg/mL Solution for Intravitreal Injection

Drug: aflibercept

Other Names:

Eylea

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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