Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications
Conditions
Interventions
None listed
Sponsors
Jagat Pharma Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with type 1 and 2 diabetes mellitus. 2. Subjects diagnosed with mild to moderate cases of non-proliferative diabetic retinopathy, in whom pan retinal photocoagulation is not imminently required in the ophthalmologist’s judgment. 3. Best corrected ETDRS VA in study eye greater than 49 letters 4. HbA1C less than 8 percent 5. Able and willing to give informed consent
Exclusion criteria
Exclusion criteria: 1. Complicating severe vitreous haemorrhage, or requiring laser and vitrectomy treatment. 2. Subjects who have received Retina laser photocoagulation. 3. Subjects whose dioptric media is so turbid that hard to evaluate the fundus picture. 4. Retinal conditions which may mask assessment e.g. retinal vein occlusion 5. Systolic blood pressure greater than 180 mm of Hg or diastolic blood pressure greater than 110 mm of Hg 6. History of major ocular surgery (scleral buckle, any intraocular surgery etc. in the study eye within prior 6 months 7. DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month from screening visit. 8. History of systemic corticosteroids within 3 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 3 times per week. 9. Previous treatment with intravitreal or sub tennon triamcinilone within the past 3 months in the study eye. 10. Previous participation in any studies of investigational drugs within 1- month preceding day 0 (excluding vitamins and minerals) 11. Subject with other severe Diabetic complications. 12. Having known allergic reaction to ingredients of Isotine CD eye Drops and capsule Iso DR 13. Pregnant or breast feeding. 14. Subjects with glaucoma, uveitis, ocular neuropathy and severe cataract etc. 15. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative change in retinal micro-hemorrhages and macular edema as assessed by fundoscopyTimepoint: Screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). Comparative change in retinal soft and hard exudates and microaneurysms as assessed by fundoscopy 2). Comparative change in Visual acuity 3). Comparative change in ETDRS-DRSS scale 4). Global assessment for overall change by investigator and subject 5). Assessment of tolerability of study drugs by investigator and subject 6). Assessment of adverse events Timepoint: Screening Visit (up to Day 5 days), Baseline Visit (Day 0), Visit 1 (Day 90), Visit 2 (Day 180) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed