Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148330
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2005-09-06
Brief Title:
Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
An Open Label Extension of the Phase IIIII Clinical Trial of Intravitreal Triamcinolone on the Effects and Safety of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment
Status:
COMPLETED
Status Verified Date:
2005-05
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:
This open label extension will treat all the eyes of study participants with active study medication intravitreal triamcinolone as well as standard laser treatment where appropriate
The specific aims will be to test the following hypotheses
That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years
The specific aims will be to test the following hypotheses
That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment remains efficacious over five years
That intravitreal triamcinolone for diabetic macular oedema that persists or recurs after laser treatment retains a manageable and acceptable safety profile over five years
Detailed Description:
A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that patients face People using insulin are particularly challenged because they are unable accurately to draw up their dose of drug Most cases of vision impairment in diabetes are due to macular oedema that persists or recurs after laser treatment There are now a number of uncontrolled anecdotal reports that intravitreal triamcinolone IVTA is highly effective for the treatment of diabetic macular edema which is refractory to conventional laser treatment We commenced the first placebo-controlled double masked clinical trial of IVTA for refractory macular oedema in 2002 The 3 month results from this study provide the first scientific proof of principle that IVTA reduces macular thickness and improves vision The two year results will be available in March 2005 but confidential interim analysis of efficacy data in September 2004 suggested that the beneficial effect of triamcinolone treatment persisted Thus it appears that treatment with IVTA may be the most significant development for the prevention of blindness in people with diabetes since the introduction of laser treatment It would also be a highly cost-effective intervention that could be administered by general ophthalmologists The treatment cannot be recommended for routine use however until its long term efficacy and safety have been established Since we already have a well studied group of patients who have received treatment for 2 years we are in a unique position to extend the study in order to provide the long-term 5-year safety and efficacy data that does not appear to be forthcoming from any other source The completion of this study will have a direct and immediate effect on the risk of blindness in people with diabetes by allowing doctors to predict more accurately the long term effects of this promising new treatment
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