Efficacy and Safety of Fenofibrate in the Progression of Diabetic Retinopathy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Primary outcome will be advancing two or more steps for participants who had any DR at baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale, based on evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period, or both (ETDRS 1991)
研究概览
简要总结
This prospective, double-masked, randomized, placebo-controlled trial at PGIMER, Chandigarh will assess the efficacy and safety of oral choline fenofibrate 135 mg in patients with diabetic retinopathy over a follow-up period of 3 months. The primary outcome is progression of diabetic retinopathy, defined as advancement by two or more steps on the ETDRS severity scale. Secondary outcomes include change in OCT thickness, change in visual acuity, and safety parameters. A total sample size of 56 patients (28 per group) has been calculated to achieve 80% power at a two-sided alpha level of 0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged 18 years and above, of either sex, diagnosed with diabetic retinopathy.
- •Duration of diabetes mellitus for more than one year.
- •Ocular treatment–naïve patients with mild diabetic retinopathy to severe non-proliferative diabetic retinopathy, with no diabetic macular edema (DME) or non-centre-involving DME (nci-DME).
- •Patients with untreated or treated resting mean sitting systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg.
排除标准
- •1.Known allergy to fenofibrate.
- •2.Chronic kidney disease or estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m².
- •3.Serum ALT greater than 3 times the ULN.
- •4.History of photosensitivity or myopathy/rhabdomyolysis.
- •5.History of pancreatitis, deep vein thrombosis, gall bladder disease, or untreated hypothyroidism.
- •6.Record of the occurrence or current existence of proliferative retinopathy.
- •7.History or presence of center-involving diabetic macular edema (ci-DME).
- •8.Coexisting macular diseases other than DME.
- •9.Historical records or documented instances of photocoagulation of the retina or intravitreal injections.
- •10.Patients on coumarin anticoagulant therapy.
- •11.Pregnant and lactating women.
- •12.Degree of cataract or media opacity that hinders the ability to acquire gradable retinal photographs.
- •13.Angle-closure glaucoma which prevents pharmacological dilation of the pupil.
结局指标
主要结局
Primary outcome will be advancing two or more steps for participants who had any DR at baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale, based on evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period, or both (ETDRS 1991)
时间窗: At baseline and at 3 months of follow-up
次要结局
- Number of patients converting from NPDR lower grade to NPDR higher grade
研究者
Dr Ashish Thomas George
Postgraduate Institute of Medical Education and Research