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OpenTrials
Completed

NCT Number: NCT02441907

Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in 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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Michael's Hospital Eye Clinic

Toronto, Ontario, M5C2T2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aflibercept

Drug

Other names: Eylea

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
May 12, 2015
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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