CTRI/2019/05/018928
Recruiting
未知
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 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: E103- Type 1 diabetes mellitus with ophthalmic complicationsHealth Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
- Sponsor
- Rasayani Biologics Pvt Ltd Pune
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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