A multicentric open labelled single arm clinical study to evaluate the effect of NTGX-10 in the treatment of Patients with Diabetic Retinopathy.

Rasayani Biologics Pvt Ltd Pune0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1 Type 1 or Type 2 diabetes mellitus
•2 18 years or older
•3 Patients of NPDR DME and PDR defined as follows
•4 Severe non-proliferative diabetic retinopathy NPDR four-quadrant haemorrhage two-quadrant venous beading or one-quadrant based on the 4:2:1 rule intraretinal microvascular abnormalities
•5 Diabetic macular oedema Haemorrhage microaneurysms exudates or thickening within one disk diameter of the fovea, or unexplained visual acuity loss
•6 Proliferative diabetic retinopathy PDR Formation of new blood vessels

•1 Presence of eye disorders other than diabetic retinopathy that may affect the progression of diabetic retinopathy or cause vision loss.
•2 Patients who are allergic to Fluorescent sodium.
•3 Patients with Glaucoma
•4 Presence of central cataract
•5 Patients with vitreous Haemorrhage
•6 Presence of severe unstable angina pectoris
•7 Presence of malignancy
•8 Patient receiving Anti VEGF therapy or received in last 2 months
•9 Severe uncontrolled Diabetes as determined by HbA1c >= 13.0%
•10 Patients of severe uncontrolled hypertension as defined by systolic BP > 170 mm/hg
•11 Presence of any other illness which in the opinion of Investigator will confound with the outcomes of the study or will adversely affect the study participation.

发起方

Rasayani Biologics Pvt Ltd Pune