A Comparison of Islet Cell Transplantation With Medical Therapy on the Risk of Progression of Diabetic Retinopathy and Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Composite outcome consisting of progression of DR, development of significant ME, or moderate visual loss in patients who have significant ME at randomization.
研究概览
简要总结
Diabetic eye disease remains a major cause of visual loss for individuals with type 1 diabetes, despite currently available treatments. Preliminary studies indicate that islet cell transplantation, a new treatment for type 1 diabetes, may be beneficial for some people. This study is designed to test the hypothesis that islet cell transplantation is more effective than current medical therapy in preventing the progression of diabetic eye disease.
详细描述
Study Purpose
The purpose of the study is to determine if islet cell transplantation (ICT) is more effective than intensive medical therapy at reducing the progression of diabetic retinopathy.
Hypothesis
ICT will result in less progression of diabetic retinopathy than intensive medical therapy. The null hypothesis states that there is no difference between ICT and intensive medical therapy in the chance of progression of diabetic retinopathy.
Study design: prospective, single-centre, randomized clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject level Criteria
- •similar to those used in our initial study (Warnock 2005)
- •age 20 - 60 years
- •type 1 diabetes for > 5 years with negative C peptide
- •GFR > 70 ml/min
- •Panel reactive antibody titre ≤ 15%
- •Non-smoker for ≥ 1 year
- •Body mass index (BMI) ≤ 28
- •Ability to provide informed consent
- •Eye criteria (must be present in both eyes)
- •Presence of moderate to severe nonproliferative diabetic retinopathy (NPDR) (grades 43 - 53 inclusive) in each eye with no plan for panretinal photocoagulation (PRP) earlier than recommended by guidelines
- •Best corrected VA 20/40 (70 letters) or better in each eye
- •Media clarity sufficient to obtain fundus photographs and optical coherence tomography (OCT)
排除标准
- •Subject level criteria
- •Previous organ transplant
- •History of malignancy other than non-melanoma skin cancer
- •Active heart disease
- •Planned pregnancy
- •Active infection
- •Lack of compliance to follow the requirements of intensive medical management of diabetes and immunosuppression protocols
- •Eye level criteria
- •History of PRP. Prior focal/grid photocoagulation more than 6 months previously for clinically significant macular edema (CSME) is not an exclusion criteria or previous limited local laser treatment
- •Macular edema from a cause other than diabetes
- •An ocular condition other than diabetes that, in the opinion of the investigator, might affect the progression of DR, ME or alter VA during the course of the study
- •History of major ocular surgery with the previous 6 months or anticipated within 3 years of randomization
结局指标
主要结局
Composite outcome consisting of progression of DR, development of significant ME, or moderate visual loss in patients who have significant ME at randomization.
次要结局
未报告次要终点