Evaluation of Efficacy and Safety of Isotine CD eye drop and capsule Iso DR in Subjects Suffering from Non proliferative Diabetic Retinopathy NPDR A randomized, Open labeled, multi-center, comparative, interventional, prospective, clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparative change in retinal micro-hemorrhages and macular edema as assessed by fundoscopy
研究概览
简要总结
It is a clinical study to evaluate of efficacy and safety of Isotine CD eye drop and capsule Iso DR in subjects suffering from Non proliferative Diabetic Retinopathy (NPDR). The clinical study will be conducted at 4 to 5 centres in India. As per computer generated randomization list, subjects will be randomized either to Isotine CD eye drop and capsule Iso DR group or standard treatment group in 1: 1 ratio. Subjects in Isotine CD eye drop and capsule Iso DR group will be asked to put given medication (Isotine CD eye drop) in a dose of 1 drop in each eye 4-5 times daily and capsule Iso DR in a dose of 1 capsule twice daily orally after meals with water for a period of 6 months. Subjects in the standard treatment group will be given standard of care for a period of 6 months. The primary objective of the study will be to assess comparative change in retinal micro-hemorrhages and macular edema as assessed by fundoscopy. The secondary objectives of the study will be to assess comparative change in retinal soft and hard exudates and microaneurysms as assessed by fundoscopy, comparative change in Visual acuity, comparative change in ETDRS-DRSS scale, global assessment for overall change by investigator and subject, assessment of tolerability of study drugs by investigator and subject and adverse events on screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with type 1 and 2 diabetes mellitus.
- •Subjects diagnosed with mild to moderate cases of non-proliferative diabetic retinopathy, in whom pan retinal photocoagulation is not imminently required in the ophthalmologist’s judgment.
- •Best corrected ETDRS VA in study eye greater than 49 letters
- •HbA1C less than 8 percent
- •Able and willing to give informed consent.
排除标准
- •Complicating severe vitreous haemorrhage, or requiring laser and vitrectomy treatment.
- •Subjects who have received Retina laser photocoagulation.
- •Subjects whose dioptric media is so turbid that hard to evaluate the fundus picture.
- •Retinal conditions which may mask assessment e.g. retinal vein occlusion
- •Systolic blood pressure greater than 180 mm of Hg or diastolic blood pressure greater than 110 mm of Hg
- •History of major ocular surgery (scleral buckle, any intraocular surgery etc.
- •in the study eye within prior 6 months
- •DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month from screening visit.
- •History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week.
- •Previous treatment with intravitreal or sub tennon triamcinilone within the past 3 months in the study eye.
- •Previous participation in any studies of investigational drugs within 1- month preceding day 0 (excluding vitamins and minerals)
- •Subject with other severe Diabetic complications.
- •Having known allergic reaction to ingredients of Isotine CD eye Drops and capsule Iso DR
- •Pregnant or breast feeding.
- •Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol.
结局指标
主要结局
Comparative change in retinal micro-hemorrhages and macular edema as assessed by fundoscopy
时间窗: Screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180)
次要结局
- 1). Comparative change in retinal soft and hard exudates and microaneurysms as assessed by fundoscopy(2). Comparative change in Visual acuity)
研究者
Dr Pushpalata D Ingale
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik