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

NCT02441907 | Completed Phase 4

• 1 other identifier: Aflibercept Cytokine DME
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Ocular Cytokines; Triamcinolone Acetonide

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept

  3 months

Study Arms (1)

aflibercept treatment

OTHER

aflibercept, 40 mg/mL Solution for Intravitreal Injection

Drug: aflibercept

Interventions

aflibercept DRUG

Also known as: Eylea

aflibercept treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital Eye Clinic

Toronto, Ontario, M5C2T2, Canada

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Rajeev Muni, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 12, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

CA (1)