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Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science 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:

  • Presence of Non Proliferative Diabetic Retinopathy (NDPR) or Proliferative Diabetic Retinopathy as confirmed by IntraVenous Fluorescein Angiography (IVFA)
  • Prior treatment with ≥ 6 intravitreal anti-VEGF injections but no treatment in last 4 weeks
  • Less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline
  • Less than 10% reduction in macular volume
  • Age 18 years or older
  • Subjects with Type I or II diabetes mellitus
  • snellen Acuity 20/40 to 20/400 and its ETDRS equivalent
  • Ability to provide signed informed consent
  • Capable of complying with study protocol.

Exclusion Criteria:

  • Previous intraocular injection of steroid medication.
  • Concurrent ocular disease (wet Age-Related Macular Degeneration, significant Epiretinal Membrane, vitreomacular traction etc) that would limit visual acuity in the opinion of the treating physician
  • Proliferative diabetic retinopathy in the study eye or PanRetinal Photocoagulation within the last 12 months
  • Poor glycemic control HbA1c >9%
  • Prior vitrectomy surgery.
  • Prior intraocular surgery within 3 months in study eye
  • Laser treatment within 3 months of study eye
  • Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to study enrollment.
  • Known history of Intraocular Pressure (IOP) elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
  • Known allergies to study drug or fluorescein
  • History of stroke or acute Myocardial Infarction within 6 months of enrolment
  • Patients receiving dialysis for renal failure
  • Patients currently on systemic immunosuppression
  • Patients with glaucoma
  • 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

Triamcinolone Acetonide Treatment

Arm Description

Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection

Outcomes

Primary Outcome Measures

Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection
Note that the 2nd triamcinolone acetonide injection occurs 3 months after baseline injection. The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.

Secondary Outcome Measures

Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).

Full Information

First Posted
August 18, 2014
Last Updated
September 17, 2019
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02221453
Brief Title
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
Official Title
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (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. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®). However, some patients do not respond well to these anti-VEGF treatments will be given the option of switching to an another class of medications, called steroids. Triamcinolone acetonide is one of these steroids and is also injected directly into the eye. These steroids will help reduce inflammation and possibly as a consequence, reduce swelling in the eye. The purpose of this study is to determine what cellular factors affect a patient's treatment response (amount of swelling reduction) following triamcinolone acetonide intravitreal injections for diabetic macular edema.

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
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone Acetonide Treatment
Arm Type
Other
Arm Description
Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Triesence
Primary Outcome Measure Information:
Title
Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months
Description
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Time Frame
3 months after baseline triamcinolone acetonide injection
Title
Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection
Description
Note that the 2nd triamcinolone acetonide injection occurs 3 months after baseline injection. The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Time Frame
3 months after 2nd triamcinolone acetonide injection
Secondary Outcome Measure Information:
Title
Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
Description
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
Time Frame
3 months after baseline injection
Title
Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
Description
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in ETDRS BCVA is in ETDRS letters.
Time Frame
3 months after 2nd triamcinolone acetonide injection
Title
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
Description
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).
Time Frame
3 months after baseline injection
Title
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
Description
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1. Change in CMT is in micrometers (um).
Time Frame
3 months after 2nd triamcinolone acetonide injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of Non Proliferative Diabetic Retinopathy (NDPR) or Proliferative Diabetic Retinopathy as confirmed by IntraVenous Fluorescein Angiography (IVFA) Prior treatment with ≥ 6 intravitreal anti-VEGF injections but no treatment in last 4 weeks Less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline Less than 10% reduction in macular volume Age 18 years or older Subjects with Type I or II diabetes mellitus snellen Acuity 20/40 to 20/400 and its ETDRS equivalent Ability to provide signed informed consent Capable of complying with study protocol. Exclusion Criteria: Previous intraocular injection of steroid medication. Concurrent ocular disease (wet Age-Related Macular Degeneration, significant Epiretinal Membrane, vitreomacular traction etc) that would limit visual acuity in the opinion of the treating physician Proliferative diabetic retinopathy in the study eye or PanRetinal Photocoagulation within the last 12 months Poor glycemic control HbA1c >9% Prior vitrectomy surgery. Prior intraocular surgery within 3 months in study eye Laser treatment within 3 months of study eye Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to study enrollment. Known history of Intraocular Pressure (IOP) elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg. Known allergies to study drug or fluorescein History of stroke or acute Myocardial Infarction within 6 months of enrolment Patients receiving dialysis for renal failure Patients currently on systemic immunosuppression Patients with glaucoma 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 MSc FRCSC
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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Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide

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