Diabetic Macular Edema Clinical Trial
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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