NCT01320345进行中（未招募）3 期
A Randomised Trial to Evaluate the Efficacy on Retinopathy and Safety of Fenofibrate in Adults With Type 1 Diabetes. A Multicentre Double-blind Placebo-controlled Study in Australia and Internationally.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 412
- 试验地点
- 23
- 主要终点
- Occurrence of clinical significant retinopathy progression.
研究概览
简要总结
The purpose of this study is to evaluate the potential benefits of 145 mg of daily fenofibrate in adults with type 1 diabetes mellitus and pre-existing non-proliferative diabetic retinopathy.
详细描述
Diabetes is the most common cause of adult onset blindness. Irreversible vision loss is a most feared complication of diabetes. Fenofibrate is a blood fat lowering drug available in Australia and has been shown to reduce eye damage in people with Type 2 diabetes by 35-40%, and to prevent eye damage in Type 1 diabetic animal models. This study will evaluate the potential benefits of oral Fenofibrate 145mg once daily for average 36 months in 450 adults with Type 1 diabetes mellitus who are at high risk of eye damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •(for the main study):
- •Men or non-pregnant women (on acceptable contraception) with T1D* according to standard criteria:
- •T1D defined as either (1) T1D diagnosed below 40 years of age and insulin therapy commencing within one year of T1D diagnosis, or (2) T1D diagnosed before, at or after 40 years of age along with: i) Documented history of ketoacidosis, and/or ii) Documented history of very low or undetectable C-peptide (fasting <200 nmol/L or 0.2 pmol/L), and/or iii) Documented history of T1D related autoantibody/ies (anti-Glutamic acid decarboxylase, anti-A2, anti-ZnT8).
- •Age 18 years or over;
- •Estimated glomerular filtration rate (eGFR) must exceed 30 ml/min/1.73m2;
- •Must have at least one eligible eye with non-proliferative retinopathy (ETDRS score 35-53 inclusive) confirmed by current retinal photography within the last 3 months (irrespective of prior laser therapy). Note: Any eye having undergone prior pan-retinal laser therapy is not eligible, but prior focal, macular or grid laser does not exclude that eye from eligibility.;
- •All types of insulin therapy, with no restriction by level of HbA1c;
- •Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances;
- •Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study.
- •Eligibility criteria for the reference group is limited to age and gender matched individuals who do not have T1D.
排除标准
- •Definite indication for or contraindications to fibrate treatment (Other lipid drugs [e.g. statins, ezetimibe, fish oils] are allowed.);
- •Need for bilateral intra-ocular treatment or laser photocoagulation therapy within the next 3 months (this exclusion only applies to retinal laser photocoagulation treatment to the posterior pole i.e. laser correction of corneas for short-sightedness is NOT an exclusion criterion);
- •Prior bilateral pan-retinal photocoagulation (PRP) treatment for diabetic retinopathy;
- •Prior bilateral intra-ocular injection(s) within the last 6 months;
- •Bilateral cataract surgery within the last 6 months;
- •Planned bilateral cataract surgery within the next 12 months;
- •History of any other non-diabetic eye disease that is or is likely to affect bilateral vision;
- •History of photosensitive skin rash or myositis;
- •Abnormal thyroid function (untreated);
- •Liver function tests exceeding 3x upper limit of normal (ULN);
- •Persistent elevated unexplained blood creatinine phosphokinase level above normal range;
- •Documented fasting triglycerides (TG) levels >6.5 mmol/L;
- •History of pancreatitis, deep vein thrombosis (DVT) or pulmonary embolism;
- •Use of investigational drugs in the prior 8 weeks;
- •Any unstable condition in last 3 months including active sepsis, diabetic ketoacidosis;
- •Myocardial infarction (MI), unstable angina, stroke or heart failure within last 6 months;
- •Diagnosed cancer with ongoing treatment or prognosis anticipated at <5 years;
- •Any obstacle to regular follow-up including scheduled clinic attendances;
- •Prior or planned organ transplantation (including islet cells) with subsequent continued immunosuppression therapy.
研究组 & 干预措施
Fenofibrate
Experimental
145 mg tablet of fenofibrate administered daily for 36 months.
干预措施: Fenofibrate (Drug)
Placebo
Placebo Comparator
Inert lactose tablet (otherwise matching active) administered daily for 36 months.
干预措施: Inert lactose placebo (Drug)
结局指标
主要结局
Occurrence of clinical significant retinopathy progression.
时间窗: As reported throughout the study and/or annual eye assessment post-randomisation
Comprising 2-step progression of ETDRS score (to at least moderately severe grade), clinically significant macular oedema, need for laser surgery, need for intraocular anti-VEGF or corticosteroid therapy or vitrectomy, adjudicated to be for diabetic retinopathy (DR)
次要结局
- The individual components of the primary endpoint(At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).)
- Occurrence of clinically significant macula oedema (CSME).(As reported throughout the study)
- Need for laser surgery for DR(As reported throughout the study)
- Need for intraocular anti-VEGF or corticosteroid injection or vitrectomy(As reported throughout the study)
- Visual acuity.(At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).)
- Macular volume and thickness(At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).)
- Albuminuria.(At baseline, 12 m post-randomisation, 24 m post-randomisation, the end of study visit (which is on average 36 months post-randomisation) and wash-out visit.)
- Estimated glomerular filtration rate.(At study completion and washout visit)
- Peripheral neuropathy status(At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).)
- Autonomic neuropathy.(At baseline, 12 m post-randomisation, 24 m post-randomisation and the end of study visit (which is on average 36 months post-randomisation).)
- Total cardiovascular events.(As reported throughout the study.)
- Frequency of foot ulcer and non-traumatic amputation.(As reported throughout the study)
研究者
研究点 (23)
Loading locations...
相似试验
进行中（未招募）
3 期
Fenofibrate for Prevention of DR WorseningDiabetic RetinopathyNCT04661358Jaeb Center for Health Research563
撤回
1 期
Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033ObesityNCT00376285Pfizer
已完成
2 期
Safety and Efficacy of Fenofibrate as a Treatment for Huntington's DiseaseHuntington DiseaseNCT03515213University of California, Irvine10
已完成
2 期
A Randomized, Double-Blind Trial Comparing the Efficacy and Safety of Fenofibrate, Metformin, Their Combination and Placebo in Patients With Metabolic Syndrome.Patients With Metabolic SyndromeNCT00703755Solvay Pharmaceuticals2,288
终止
2 期
Effect of Fenofibrate on Sleep Apnea SyndromeOverweightObesityDyslipidemiaSleep Apnea SyndromeNCT00816829Solvay Pharmaceuticals34