Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study
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
Timeline
- Start
- 2005-05
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Met primary endpoint
paper The mean improvement in VA was 5.7 letters (95% confidence interval, 1.4-9.9) more in the intravitreal TA-treated eyes than in those treated with the placebo. PMID 16828501 ↗
paper Improvement of > or =5 letters' best-corrected VA was found in 19 of 34 (56%) eyes treated with intravitreal TA, compared with 9 of 35 (26%) eyes treated with the placebo (z(generalized estimating equation) = 2.73, P = 0.006). PMID 16828501 ↗
Publications
- Background Sutter FK, Simpson JM, Gillies MC. Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial. Ophthalmology. 2004 Nov;111(11):2044-9. doi: 10.1016/j.ophtha.2004.05.025.
- Background Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005 May;139(5):802-6. doi: 10.1016/j.ajo.2004.12.054.
- Background Kuo CH, Gillies MC. Role of steroids in the treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):121-34. doi: 10.1097/IIO.0b013e31819fcce8. No abstract available.
- Results Gillies MC, Simpson JM, Gaston C, Hunt G, Ali H, Zhu M, Sutter F. Five-year results of a randomized trial with open-label extension of triamcinolone acetonide for refractory diabetic macular edema. Ophthalmology. 2009 Nov;116(11):2182-7. doi: 10.1016/j.ophtha.2009.04.049. Epub 2009 Oct 1.
- Results Gillies M. Diabetic macular edema. Ophthalmology. 2009 Mar;116(3):595; author reply 596-7. doi: 10.1016/j.ophtha.2008.12.016. No abstract available.
- Results Gillies MC, Simpson JM, Zhu M, Hunt G, Ali H, Gaston C. Intravitreal triamcinolone. Ophthalmology. 2009 Mar;116(3):591. doi: 10.1016/j.ophtha.2008.09.044. No abstract available.
- Results Gillies MC, Sutter FK, Simpson JM, Larsson J, Ali H, Zhu M. Intravitreal triamcinolone for refractory diabetic macular edema: two-year results of a double-masked, placebo-controlled, randomized clinical trial. Ophthalmology. 2006 Sep;113(9):1533-8. doi: 10.1016/j.ophtha.2006.02.065. Epub 2006 Jul 7.
- Results Larsson J, Kifley A, Zhu M, Wang JJ, Mitchell P, Sutter FK, Gillies MC. Rapid reduction of hard exudates in eyes with diabetic retinopathy after intravitreal triamcinolone: data from a randomized, placebo-controlled, clinical trial. Acta Ophthalmol. 2009 May;87(3):275-80. doi: 10.1111/j.1755-3768.2008.01245.x. Epub 2008 Sep 10.
- Wickremasinghe SS, Rogers SL, Gillies MC, Zhu M, Wong TY. Retinal vascular caliber changes after intravitreal triamcinolone treatment for diabetic macular edema. Invest Ophthalmol Vis Sci. 2008 Nov;49(11):4707-11. doi: 10.1167/iovs.08-1678. Epub 2008 Jul 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Triamcinolone | Other / unclassified | 4 mg | Intravitreal |