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A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00369863
First Posted: August 30, 2006
Last Update Posted: February 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.

Condition Intervention Phase
Diabetic Macular Edema Drug: Triamcinolone acetonide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Central macular thickness

Secondary Outcome Measures:
  • Visual acuity
  • intraocular pressure
  • Cataract progression
  • Cystoid macular edema
  • Macular hard exudates
  • Macular leakage severity in FA

Estimated Enrollment: 76
Study Start Date: June 2002
Estimated Study Completion Date: June 2003
Detailed Description:

Overall 80% of diabetic patients with low vision are in the nonproliferative stage and the main cause of decreased visual acuity is macular edema.

According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema (DME) is laser therapy, which may be neither effective nor curative in some patients.There are many cases which are refractory to laser treatment or not suitable candidates for it.

Corticosteroids might have a beneficial effect on DME. They have been used with different doses and routes (periocular,intravitreal,and slow released implants) for a variety of retinal diseases.

Recently, a few prospective randomized studies, concerning the effect of intravitreal triamcinolone acetonide (IVT) on DME have been published. In their two-year results, Gillies et al. concluded that IVT improved vision and reduced macular thickness in eyes with refractory diabetic macular edema. They showed that this beneficial effect persisted for up to 2 years with repeated treatment.

We also conducted a randomized placebo-controlled clinical trial to determine the safety and efficacy of IVT for intractable DME. Besides, we tried to evaluate the effect of this intervention on angiographic findings of these patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   44 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically significant macular edema(CSME)
  • Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation

Exclusion Criteria:

  • Mono-ocular patients
  • History of vitrectomy
  • Glaucoma or ocular hypertension
  • Significant media opacity
  • Traction on the macula
  Contacts and Locations
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): NCT00369863


Locations
Iran, Islamic Republic of
Labbafinejad Medical Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Mohammad - Hossein Dehghan, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00369863     History of Changes
Other Study ID Numbers: 8126
First Submitted: August 29, 2006
First Posted: August 30, 2006
Last Update Posted: February 28, 2007
Last Verified: February 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:
Cystoid macular edema
Diabetic macular edema
Hard exudates
Intravitreal triamcinolone
Macular thickness

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
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


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