Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Patients With Persistent Diabetic Macular Edema Following Treatment With Ranibizumab: An Interventional Prospective Study

January 7, 2016 updated by: Unity Health Toronto

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.

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-VEGF agents which help to reduce the leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).

However, some patients do not respond well to these anti-VEGF treatments and will be given the option of switching to an another newer anti-VEGF medication, called aflibercept (Eylea®) that is approved to treat DME. A recent large study has demonstrated that aflibercept was as efficacious as other anti-VEGF therapies listed above and was even superior in patients with worse vision (Diabetic Retinopathy Clinical Research Network, Wells JA, Glassman AR, et al. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema. N Engl J Med. 2015:150218140025008-150218140025008).

The purpose of this study is to determine what factors affect the treatment response to aflibercept (amount of swelling reduction) for patients with diabetic macular edema, who were previously unresponsive to ranibizumab injections.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

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 Contact

  • Name: Phillip To
  • Phone Number: 4168677411
  • Email: top@smh.ca

Study Contact Backup

  • Name: Rajeev Muni, MD
  • Phone Number: 4168677411

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)
  • Prior treatment with ≥ 6 intravitreal ranibizumab injections but no treatment in the last 4 weeks and less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline and less than 10% reduction in macular volume with Snellan Acuity 20/40 to 20/400
  • 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 enrolment
  • 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
aflibercept treatment aflibercept, 40 mg/mL Solution for Intravitreal Injection
Biological: aflibercept
EYLEA (aflibercept, solution for intravitreal injection) is a recombinant fusion protein consisting of portions of human Vascular Endothelial Growth Factor (VEGF) receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
Other Names:
  • Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cytokine levels (picograms per mL) in patients with DME who were previously non-responders to ranibizumab (non-responders) between baseline aflibercept injection.
Time Frame: 1month, 2 months, 3 months
1month, 2 months, 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relation of baseline aqueous cytokine levels in patients with DME who were previously non-responders to ranibizumab (non-responders) 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, St. Michael's Hospital Eye Clinic, Toronto, Ontario, Canada, M5C2T2

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

March 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol B SMH Aflibercept

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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