A Randomized, Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Information source: Shaheed Beheshti Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Macular Edema
Intervention: Triamcinolone acetonide (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shaheed Beheshti Medical University Official(s) and/or principal investigator(s):
Mohammad - Hossein Dehghan, MD, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
Summary
To determine the efficacy and safety of intravitreal triamcinolone acetonide for refractory
diabetic macular edema.
Clinical Details
Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Central macular thickness
Secondary outcome: Visual acuityintraocular pressure Cataract progression Cystoid macular edema Macular hard exudates Macular leakage severity in FA
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.
Eligibility
Minimum age: 44 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Labbafinejad Medical Center, Tehran 16666, Iran, Islamic Republic of
Additional Information
Starting date: June 2002
Ending date: June 2003
Last updated: February 27, 2007
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