A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
NCT ID: NCT00369863
Last Updated: 2007-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2002-06-30
2003-06-30
Brief Summary
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Detailed Description
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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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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Triamcinolone acetonide
Eligibility Criteria
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Inclusion Criteria
* Clinically significant macular edema(CSME)refractory to initial or supplemental macular photocoagulation
Exclusion Criteria
* History of vitrectomy
* Glaucoma or ocular hypertension
* Significant media opacity
* Traction on the macula
44 Years
79 Years
ALL
No
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Principal Investigators
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Mohammad - Hossein Dehghan, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Research Center of Shaheed Beheshti Medical University
Locations
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Labbafinejad Medical Center
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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8126
Identifier Type: -
Identifier Source: org_study_id