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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
aflibercept
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, Ocular Cytokines, Triamcinolone Acetonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Michael's Hospital Eye Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

aflibercept treatment

Arm Description

aflibercept, 40 mg/mL Solution for Intravitreal Injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2015
Last Updated
September 17, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02441907
Brief Title
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Diabetic Macular Edema
Official Title
Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Treatment Naïve Patients With Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, Ocular Cytokines, Triamcinolone Acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aflibercept treatment
Arm Type
Other
Arm Description
aflibercept, 40 mg/mL Solution for Intravitreal Injection
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
Eylea
Primary Outcome Measure Information:
Title
Change in cytokine levels (picograms per mL) between baseline aflibercept injection and at 1, 2, and 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relation of baseline aqueous cytokine levels to baseline Snellen BCVA in response to aflibercept
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajeev Muni, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital Eye Clinic
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C2T2
Country
Canada

12. IPD Sharing Statement

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

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