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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00369863
Other study ID # 8126
Secondary ID
Status Completed
Phase Phase 2
First received August 29, 2006
Last updated February 27, 2007
Start date June 2002
Est. completion date June 2003

Study information

Verified date February 2007
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 44 Years to 79 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone acetonide


Locations

Country Name City State
Iran, Islamic Republic of Labbafinejad Medical Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Central macular thickness
Secondary Visual acuity
Secondary intraocular pressure
Secondary Cataract progression
Secondary Cystoid macular edema
Secondary Macular hard exudates
Secondary Macular leakage severity in FA
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