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

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ClinicalTrials.gov Identifier: NCT02221453
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE August 18, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date September 19, 2019
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months [ Time Frame: 3 months after baseline triamcinolone acetonide 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.
  • Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02221453 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • 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 [ Time Frame: 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. 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 [ Time Frame: 3 months after 2nd triamcinolone acetonide 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. 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 [ Time Frame: 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. 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 [ Time Frame: 3 months after 2nd triamcinolone acetonide 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. Change in CMT is in micrometers (um).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
Official Title  ICMJE Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE Drug: Triamcinolone Acetonide
Other Name: Triesence
Study Arms  ICMJE Triamcinolone Acetonide Treatment
Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection
Intervention: Drug: Triamcinolone Acetonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02221453
Other Study ID Numbers  ICMJE PersDMEcytokineTA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajeev Muni, MD MSc FRCSC St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP