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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00369863
Enrollment
76
Registered
2006-08-30
Start date
2002-06-30
Completion date
2003-06-30
Last updated
2007-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Cystoid macular edema, Diabetic macular edema, Hard exudates, Intravitreal triamcinolone, Macular thickness

Brief summary

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

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.

Interventions

DRUGTriamcinolone acetonide

Sponsors

Shahid Beheshti University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
44 Years to 79 Years
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

Design outcomes

Primary

MeasureTime frame
Central macular thickness

Secondary

MeasureTime frame
intraocular pressure
Cataract progression
Visual acuity
Macular hard exudates
Macular leakage severity in FA
Cystoid macular edema

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026