A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
- Central macular thickness
- 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 |
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:
- 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| 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
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 Triamcinolone Acetonide 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 May 23, 2013