Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148265
Status:
COMPLETED
Last Update Posted:
2010-06-23
First Post:
2005-09-06
Brief Title:
A Multicentre Randomised Clinical Trial of Laser Treatment Plus Intravitreal Triamcinolone for Diabetic Macular Oedema
Sponsor:
University of Sydney
Organization:
University of Sydney
Study Overview
Official Title:
Phase IIIII Multicentre Randomised Clinical Trial of Laser Treatment Plus 4 mg Intravitreal Triamcinolone Injection to Reduce Diabetic Macular Oedema
Status:
COMPLETED
Status Verified Date:
2005-11
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 study is likely to identify an improved and economical treatment for diabetic macular oedema one of the commonest causes of blindness both in Australia and the rest of the worldThe specific aims of the study are to test the following hypotheses
That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes
That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes
That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment
That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema
That intravitreal triamcinolone followed by laser treatment results in a greater improvement in visual acuity than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes
That intravitreal triamcinolone followed by laser treatment results in greater degree of resolution of macular oedema than placebo followed by laser treatment of eyes with macular oedema secondary to diabetes
That intravitreal triamcinolone followed by laser treatment results in a reduced requirement for further laser treatment to control diabetic macular oedema than placebo followed by laser treatment
That intravitreal triamcinolone followed laser has a manageable and acceptable safety profile in eyes with diabetic macular edema
Detailed Description:
A 25 fold increase in the risk of going blind on diagnosis of diabetes is one of the most daunting threats that people with diabetes face Stimulated by several uncontrolled anecdotal reports we are already conducting a randomized clinical trial of intravitreal triamcinolone for the treatment of diabetic macular edema which is refractory to conventional laser treatment The analysis of the 3 month data from this study has already unequivocally demonstrated that the treatment very significantly reduces or eliminates macular oedema in the short term and results in improved visual acuity Thus intravitreal triamcinolone may represent the most significant development in the prevention of blindness in people with diabetes since the introduction of laser treatment It is also a highly cost-effective intervention that can be administered by general ophthalmologists The next question to be answered which will be addressed directly by the present study is whether there is a significant synergistic beneficial effect when intravitreal steroids are combined with current therapy laser
This study represents the second major project to be undertaken by the Australian Retinal Collaboration ARC The ARC aims to set the highest attainable standards for investigator-initiated clinical research in retinal diseases in Australia Having enrolled and treated more than the target of 120 patients we are currently completing an RCT of laser induced chorioretinal anastomosis for central retinal vein occlusion an innovative Australian concept for a severe and otherwise untreatable disease The proposed study is likely to identify an improved and economical treatment for one of the commonest causes of blindness both in Australia and the rest of the world Intravitreal triamcinolone is also an intervention which has generated intense interest internationally and one for which members of the ARC are acknowledged pioneers
Successful implementation of the study proposed which is feasible is highly likely to have an immediate and direct effect on the prevention of vision impairment and blindness in people with diabetes
This study represents the second major project to be undertaken by the Australian Retinal Collaboration ARC The ARC aims to set the highest attainable standards for investigator-initiated clinical research in retinal diseases in Australia Having enrolled and treated more than the target of 120 patients we are currently completing an RCT of laser induced chorioretinal anastomosis for central retinal vein occlusion an innovative Australian concept for a severe and otherwise untreatable disease The proposed study is likely to identify an improved and economical treatment for one of the commonest causes of blindness both in Australia and the rest of the world Intravitreal triamcinolone is also an intervention which has generated intense interest internationally and one for which members of the ARC are acknowledged pioneers
Successful implementation of the study proposed which is feasible is highly likely to have an immediate and direct effect on the prevention of vision impairment and blindness in people with diabetes
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