Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407849
Status:
UNKNOWN
Last Update Posted:
2008-05-07
First Post:
2006-12-04
Brief Title:
Intravitreal Triamcinolone Acetonide for Treatment of Refractory Diffuse Diabetic Macular Edema
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Phase III Study of Intravitreal Triamcinolone Acetonide Microspheres for Treatment of Diffuse Diabetic Macular Edema Unresponsive to Conventional Laser Photocoagulation Treatment
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Phase III study with intravitreal triamcinolone acetonide microspheresRETAACfor treatment of diffuse diabetic macular edema unresponsive to laser photocoagulation Study hypothesis is that single intravitreal injection of RETAAC is safe and efficient compared to conventional treatment Fifty patients will participate in this study and will be randomized into treatment and observation groups Efficacy will be evaluated by best corrected visual acuity and macular thickness measured by optic coherence tomography OCT after 12 months of treatment
Detailed Description:
None
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