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

September 17, 2019 updated by: Unity Health Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5C2T2
        • St. Michael's Hospital Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Rajeev Muni, MD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 8, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aflibercept Cytokine DME

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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