Health Condition 1: E103- Type 1 diabetes mellitus with ophthalmic complications Health Condition 2: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
Intervention1: NTGX-10: NTGX-10 is an investigational herbomineral formulation consisting of shudha suvarna Bhasma (Aurum), Shudha Yashad Bhasma (Zinc) triturated with AmalakiSwaras Phyllanthus emblic
Sponsors
Rasayani Biologics Pvt Ltd Pune
Eligibility
Inclusion 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate change in best corrected visual acuity.Timepoint: Monthly Interval for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the amount of microaneurysms Timepoint: Amount of microaneurysm will be evaluated at baseline, day 60, day120 and post interventional i.e. day 180;To evaluate the amount of retinal haemorrhageTimepoint: Amount of retinal haemorrhage will be assessed at baseline, day 90 and post interventional i.e. day 180;To evaluate the amount and area of Intra Retinal Microvascular Abnormality (IRMA)Timepoint: Amount and area of IRMA will be evaluated at baseline, day60, day120 and post interventional i.e. day 180.;To evaluate the amount of neovascularization happened in span of 6 months form baselineTimepoint: Amount of Neovascularization will be evaluated at baseline, day 60, day120 and post interventional i.e. day 180.;To evaluate the change from baseline in contrast sensitivityTimepoint: Contrast sensitivity will be evaluated at monthly intervals;To evaluate the changes in Macular retinal thickness andTimepoint: Macular retinal thickness will be evaluated at baseline, day 60, day 120 and post interventional i.e. day 180;To Assess and study the adverse events related to the treatments. Timepoint: Adverse events will be monitored at every visit | — |
Countries
India
Contacts
Public ContactDr Avinash Kadam
Rasayani Biologics Pvt. Ltd. Pune.
Outcome results
None listed