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

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00369863

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 II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

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

Ages Eligible for Study:	44 Years to 79 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369863

Locations

Iran, Islamic Republic of
Labbafinejad Medical Center
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Mohammad - Hossein Dehghan, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00369863 History of Changes
Other Study ID Numbers:	8126
Study First Received:	August 29, 2006
Last Updated:	February 27, 2007
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

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 Acetonide
Triamcinolone
Triamcinolone diacetate

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012