Open Label Extension of a Clinical Trial of Intravitreal Triamcinolone for Diabetic Macular Oedema-TDMX Study
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Increase of ≥5 letters at the 5-year study visit on a LogMAR chart compared with (a) the initial baseline level and (b) the level at the 2-year study visit. [ Time Frame: 3 year extension, total 5 years study from baseline ] [ Designated as safety issue: No ]
Changes from Baseline to 5 years: Improvement of ≥5 letters after 5 years was found in 14/33 (42%) eyes initially treated with triamcinolone compared with 11/34 (32%) eyes initially treated with placebo (zGEE=0.81, P=0.4).
Changes from 2 to 5 years (open-label extension):Improvement of ≥5 letters of best-corrected visual acuity was found in 8/29 (28%) eyes initial-triamcinolone compared with 7/28 (25%) initial-placebo eyes (zGEE=0.20, P=0.8).
- Incidence of moderate or severe adverse events over the 3 years of the open-label extension [ Time Frame: 3 year extension study, total 5 year study from baseline ] [ Designated as safety issue: Yes ]The incidence of cataract surgery declined in the third year: 5/11 (45%) eyes from the initial-triamcinolone group that were phakic at the beginning of the 3rd year required cataract surgery.
- Change in macular thickness by OCT [ Time Frame: 3 year extension, total 5 year study from the baseline ] [ Designated as safety issue: No ]
Changes from Baseline to 5 years: Foveal thickness had decreased by 30µm (95% confidence interval, -47 to 107µm) less in the initial-triamcinolone group than in the initial-placebo group at 5 years (zGEE=0.76, P=0.45).
Changes from 2 to 5 years (open-label extension):Foveal thickness had actually increased slightly on average in the initial-triamcinolone group, but decreased in initial-placebo eyes. Overall it had decreased by 70µm (95% confidence interval, -1 to 140µm) more in the placebo group than in the treatment group between 2 and 5 years (zGEE=1.93, P=0.05).
- Any change in visual acuity [ Time Frame: 3 year extension, total 5 year study from the baseline ] [ Designated as safety issue: No ]Loss of ten or more letters was found in 6/33 (18%) initial-triamcinolone eyes compared with 8/34 (24%) initial-placebo eyes.
- Number of laser treatments required. [ Time Frame: 3 year extension study, total 5 year study from baseline ] [ Designated as safety issue: No ]During the third to fifth years of the study, a similar proportion of eyes from the 2 groups had macular edema that warranted laser treatment: initial-triamcinolone, 5/29 (17%); initial-placebo, 6/28 (21%).
|Study Start Date:||May 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Drug: Triamcinolone acetate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148330
|Australia, New South Wales|
|Save Sight Institute, Sydney/Sydney Eye Hospital Campus, University of Sydney|
|Sydney, New South Wales, Australia, 2000|
|Principal Investigator:||Mark C Gillies, MBBS, PhD||Save Sight Institute, Deaprtment of Clinical Ophthalmology, University of Sydney|