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

Study Overview
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Brief Summary
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To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory diabetic macular edema.

Detailed Description
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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.

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 44 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Triamcinolone acetonide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central macular thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| intraocular pressure |  |  | 
| Cataract progression |  |  | 
| Cystoid macular edema |  |  | 
| Macular hard exudates |  |  | 
| Macular leakage severity in FA |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness