A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.
|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
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00369863
|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|