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

S

Shahid Beheshti University of Medical Sciences

Status and phase

Completed
Phase 2

Conditions

Diabetic Macular Edema

Treatments

Drug: Triamcinolone acetonide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

44 to 79 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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