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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00369863
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Triamcinolone acetonide	Phase 2

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2002
• Study Completion Date: Jun 1, 2003

Outcome Measures

Primary Outcome Measures

1. Central macular thickness []

Secondary Outcome Measures

1. Visual acuity []

2. intraocular pressure []

3. Cataract progression []

4. Cystoid macular edema []

5. Macular hard exudates []

6. Macular leakage severity in FA []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 44 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labbafinejad Medical Center	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Mohammad - Hossein Dehghan, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00369863
• Other Study ID Numbers: 8126
• First Posted: Aug 30, 2006
• Last Update Posted: Feb 28, 2007
• Last Verified: Feb 1, 2007

• Keywords provided by , ,: Cystoid macular edema; Diabetic macular edema; Hard exudates; Intravitreal triamcinolone; Macular thickness
• Additional relevant MeSH terms: Macular Edema; Edema; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate

Study Results

No Results Posted as of Feb 28, 2007