A clinical study to evaluate effect and safety of NTGX-10 in treatment of patients with Diabetic Retinopathy
- Conditions
- Health Condition 1: E103- Type 1 diabetes mellitus with ophthalmic complicationsHealth Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
- Registration Number
- CTRI/2019/05/018928
- Lead Sponsor
- Rasayani Biologics Pvt Ltd Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to evaluate change in best corrected visual acuity.Timepoint: Monthly Interval for 6 months
- Secondary Outcome Measures
Name Time Method