Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369863
Status:
COMPLETED
Last Update Posted:
2007-02-28
First Post:
2006-08-29
Brief Title:
A Randomized Placebo-Controlled Clinical Trial of Intravitreal Triamcinolone for Refractory Diabetic Macular Edema
Sponsor:
Shahid Beheshti University of Medical Sciences
Organization:
Shahid Beheshti University of Medical Sciences
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientsThere 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 periocularintravitrealand 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
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 patientsThere 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 periocularintravitrealand 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None