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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00148265
Other study ID # NHMRC project 352312
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 6, 2005
Last updated June 21, 2010
Start date April 2005
Est. completion date May 2009

Study information

Verified date November 2005
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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 world.The 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.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Triamcinolone acetate
Eyes assigned to IVTA received an intravitreal injection of 0.1 ml of Kenacort 40© [40mg/ml triamcinolone acetonide, Bristol-Myers Squibb pharmaceuticals, Australia] on the day of the baseline visual acuity measurement under sterile conditions in a minor procedures area as an outpatient procedure. Eyes assigned to placebo were prepared in the same way but had the barrel of the syringe without a needle pushed firmly against the eye to simulate an injection.

Locations

Country Name City State
Australia Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney Sydney New South Wales

Sponsors (4)

Lead Sponsor Collaborator
University of Sydney Marsden Eye Centre, The University of Western Australia, University of Melbourne

Country where clinical trial is conducted

Australia, 

References & Publications (6)

Gillies MC, Islam FM, Zhu M, Larsson J, Wong TY. Efficacy and safety of multiple intravitreal triamcinolone injections for refractory diabetic macular oedema. Br J Ophthalmol. 2007 Oct;91(10):1323-6. Epub 2007 Apr 3. — View Citation

Gillies MC, McAllister IL, Zhu M, Wong W, Louis D, Arnold JJ, Wong TY. Pretreatment with intravitreal triamcinolone before laser for diabetic macular edema: 6-month results of a randomized, placebo-controlled trial. Invest Ophthalmol Vis Sci. 2010 May;51( — View Citation

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. — View Citation

Mohamed Q, Gillies MC, Wong TY. Management of diabetic retinopathy: a systematic review. JAMA. 2007 Aug 22;298(8):902-16. Review. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of eyes showing an improvement of visual acuity by 10 letters on a LogMAR chart compared with the pre-injection level 24 months after treatment At 24 months, improvement of =10 LogMAR letters was seen in 15/42 (36%) eyes treated with IVTA plus laser compared with 7/42 (17%) eyes treated with laser only (p=0.047, odds ratio 2.79, 95% CI, 1.01, 7.67). 24 month No
Secondary Number of laser treatments required for the treatment of macular oedema during the course of the study. At least 1 retreatment was required in the second year of the study in 29/42 (69%) of IVTA plus laser treated eyes compared with 19/42 (45%) laser only eyes (p=0.187). 24 month Yes
Secondary Change in retinal thickness demonstrated on optical coherence tomography (OCT) There was no difference in the mean CMT (346.8µm ± 114.9SD vs 372.6µm ± 154.2SD, comparing IVTA plus laser vs laser only, p=0.349) or mean logMAR visual acuity (56.1 ± 15.7SD vs 54.5 ± 16.1SD letters, p=0.439). 24 month No
Secondary The incidence of moderate or severe side effects related to the procedure of intravitreal injection or related to the drug Cataracts were removed from 17/28 (61%) of phakic IVTA plus laser-treated eyes vs. 0/27 (0%) laser only eyes (p<0.001). Treatment for elevated intraocular pressure was required in 27/42 (64%) of the IVTA plus laser eyes compared with 10/42 (24%) laser only eyes (p<0.001) 24 month Yes
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