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| 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: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 76 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | June 2003 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Iran, Islamic Republic of | |
| Labbafinejad Medical Center | |
| Tehran, Iran, Islamic Republic of, 16666 | |
| Principal Investigator: | Mohammad - Hossein Dehghan, MD | Ophthalmic Research Center of Shaheed Beheshti Medical University |
More Information
| Study ID Numbers: | 8126 |
| Study First Received: | August 29, 2006 |
| Last Updated: | February 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00369863 History of Changes |
| Health Authority: | Iran: Ethics Committee |
|
Cystoid macular edema Diabetic macular edema Hard exudates Intravitreal triamcinolone Macular thickness |
|
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Eye Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Edema Macular Degeneration Retinal Degeneration Enzyme Inhibitors Triamcinolone diacetate |
Immunosuppressive Agents Hormones Glucocorticoids Pharmacologic Actions Triamcinolone hexacetonide Macular Edema Signs and Symptoms Triamcinolone Acetonide Therapeutic Uses Triamcinolone Retinal Diseases |
