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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the study will be offered to all patients at the conclusion of the TDMO study. Currently we are still following 64 of the 69 (93%) eyes that were initially entered into the study that had reduced vision from diabetic macular oedema at baseline.
排除标准
- •Uncontrolled glaucoma
- •Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration)
- •known allergies to triamcinolone acetate, patient is already receiving systemic steroid treatment, intercurrent severe disease such as septicemia, any condition which would affect follow-up or photographic documentation (e.g. geographical, psycho-social, media opacities)
结局指标
主要结局
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.
时间窗: 3 year extension, total 5 years study from baseline
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
时间窗: 3 year extension study, total 5 year study from baseline
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.
次要结局
- Change in macular thickness by OCT(3 year extension, total 5 year study from the baseline)
- Any change in visual acuity(3 year extension, total 5 year study from the baseline)
- Number of laser treatments required.(3 year extension study, total 5 year study from baseline)