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Trial record 2 of 915 for:    triamcinolone acetonide

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

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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Triamcinolone Acetonide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Triamcinolone Acetonide Treatment
Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection
Drug: Triamcinolone Acetonide
Other Name: Triesence




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).



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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:

  • 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

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): NCT02221453


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

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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02221453     History of Changes
Other Study ID Numbers: PersDMEcytokineTA
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by St. Michael's Hospital, Toronto:
Diabetic Macular Edema
Ocular Cytokines
Triamcinolone Acetonide
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action