CTRI/2020/04/024637Other未知
Efficacy and Safety of Hydroxychloroquine Sulfate in Type 2 Diabetes Patients withNon-proliferative Diabetic Retinopathy (NPDR)
IPGMER and SSKM Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- Other
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female patients aged between >=18 and <=65 years
- •2. Type 2 diabetes with HbA1c between >=7% and <=10.5%, despite receiving stable dose of metformin + sulfonylurea with or without other OHAs (excluding DPP-IV inhibitors and hydroxychloroquine) for at least 12 weeks.
- •3. Mild to severe NPDR (DRSS levels score >= 20 and <= 53) in whom PRP (panretinal photocoagulation) can be safely deferred for at least 6 months as per the investigator/opthalmologist.
- •4. Best corrected visual acuity-early treatment diabetic retinopathy study (BCVA ETDRS) letter score in the study eye of >=65 letters [approximate Snellen equivalent of >=0.4 (20/50)]
- •5. Central foveal thickness (CFT) <= 275 µm of retina by OCT
- •6. Patients with body weight >= 60 Kg
- •7. Patients able to understand and willing to fully comply with study procedures and restrictions
- •8. Patient ready to give informed consent to participate in the study, in accordance with the International Conference for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) Guidelines, before completing any study related procedures
排除标准
- •1. Uncontrolled hyperglycemia i.e FPG >240 mg/dL
- •2. Patients with Type 1 diabetes
- •3. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
- •4. Evidence of retinal neovascularization on clinical examination
- •5. Any prior focal or grid laser photocoagulation, prior panretinal photocoagulation (PRP) or refractive surgery in the study eye
- •6. Any prior systemic anti-VEGF treatment or prior intraocular steroid injection in the study eye within 3 months from enrollment.
- •7. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment diagnosed by SD-OCT and color and red-free fundus photography, visible at the screening assessments in the study eye.
- •8. Concomitant retinal disease due to causes other than diabetic microangiopathy.
- •9. Patients with recent glaucoma and cataract surgery
- •10. Patients with dilatation of the pupil <5 mm
- •11. Patients with recent cardiovascular accident or myocardial infarction stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or transient ischemic attack, or history of congestive heart failure, or unstable angina or edema (Due to Cardio Vascular event)
- •12. Patients with DBP >100 mmHg and/or SBP >160 mmHg with or without medication
- •13. Patients with endocrine disorder other than Type 2 diabetes mellitus
- •14. Patients with eGFR <=60 mL/min/1.73 m2 as calculated by EPI criteria formula
- •15. Patients with abnormal liver function (SGOT, SGPT, total bilirubin, or alkaline phosphatase >2.5 times the upper limit of normal values) or active liver disease or patients with CPK >2.5 times the upper limit of normal value
- •16. Patients with diseases of blood or hematopietic organs or female patients with Hb <11 g/dL or male patients with Hb <12 g/dL.
- •17. Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency
- •18. Patient with history of symptomatic autonomic neuropathy
- •19. Patients with chronic gastroparesis, active gastrointestinal disorders (gastric and duodenal ulcer)
- •20. Patient with known history of diabetic ketoacidosis
- •21. Patients with hypoglycemia unawareness (Patients whose blood glucose levels fall below 70 mg/dL but they do not feel any symptoms of hypoglycemia)
- •22. Patients with malignancy and planned radiological examinations requiring administration of contrasting agents
- •23. Patients with malabsorption and pancreatitis
- •24. Patients with dementia or other cognitive impairment prohibiting informed consent
- •25. Patients with known history of HIV1/HIV2/Hepatitis B or C infection or syphilis infection
- •26. Patients with any other clinically significant abnormalities interfering with assessment of disease under evaluation
- •27. Patients with antihypertensive treatment, unless administered at stable dosage for at least 3 months before the start of the study
- •28. Patients with hemorrheological, vasoactive drugs and antithrombotics except acetylsalicylic acid at stable dosage
- •29. Patient who had any other illness for which hydroxychloroquine was indicated (such as rheumatoid arthritis, systemic lupus erythematosus [SLE])
- •30. Patients receiving/requiring insulin
- •31. Patients re
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