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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02651168
Recruitment Status : Unknown
Verified January 2016 by St. Michael's Hospital, Toronto.
Recruitment status was:  Not yet recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, 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.

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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Biological: aflibercept Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 Patients With Persistent Diabetic Macular Edema Following Treatment With Ranibizumab: An Interventional Prospective Study
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
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 Name: Eylea




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651168


Contacts
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Contact: Rajeev Muni, MD 4168677411
Contact: Phillip To 4168677411 top@smh.ca

Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Rajeev Muni, MD St. Michael's Hospital Eye Clinic, Toronto, Ontario, Canada, M5C2T2

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02651168    
Other Study ID Numbers: Protocol B SMH Aflibercept
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by St. Michael's Hospital, Toronto:
Diabetic Macular Edema
Ocular Cytokines
aflibercept
ranibizumab
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents