Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study

Diabetic Macular Oedema Clinical Trial

Official title: An Open Label Extension of the Phase II/III Clinical Trial of Intravitreal Triamcinolone on the Effects and Safety of Clinically Significant Diabetic Macular Oedema That Persists After Laser Treatment

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Oedema
• Edema
• Macular Edema

• NCT number: NCT00148330
• Study type: Interventional
• Source: University of Sydney
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2005
• Completion date: July 2008