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

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00369863
First received: August 29, 2006
Last updated: February 27, 2007
Last verified: February 2007

August 29, 2006
February 27, 2007
June 2002
Not Provided
Central macular thickness
Same as current
Complete list of historical versions of study NCT00369863 on ClinicalTrials.gov Archive Site
  • Visual acuity
  • intraocular pressure
  • Cataract progression
  • Cystoid macular edema
  • Macular hard exudates
  • Macular leakage severity in FA
Same as current
Not Provided
Not Provided
 
A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Not Provided

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Diabetic Macular Edema
Drug: Triamcinolone acetonide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
June 2003
Not Provided

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
Both
44 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00369863
8126
Not Provided
Not Provided
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Mohammad - Hossein Dehghan, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti Medical University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP