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

Phase 2

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT00369863
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2002-06
• Study Completion: 2003-06
• Study First Submitted: 2006-08-29
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-30
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-27
• Last Update Posted: 2007-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Central macular thickness

Secondary Outcome Measures

Name	Time	Method
Visual acuity
intraocular pressure
Cataract progression
Cystoid macular edema
Macular hard exudates
Macular leakage severity in FA

Trial Locations

Locations (1)

Labbafinejad Medical Center; 🇮🇷 Tehran, Iran, Islamic Republic of