Diabetes and Eye
Not Applicable
Completed
- Registration Number
- CTRI/2018/05/014060
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients must be above 18 years of age having type 1 or type 2 diabetes mellitus. Decrease in vision specifically due to DME. Retinal thickness less than 300 micron and bilaterally fit cases.
Exclusion Criteria
Active intraocular inflammation, any active infection, history of uveitis, ocular disorders, epiretinal membrane, uncontrolled glaucoma, neovascularization of the iris, evidence of vitreomacular traction, active proliferative diabetic retinopathy.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Meanchange from baseline in BCVA assessed on early treatment diabetic retinopathy study (ETDRS) chart over a period of 48 weeks of Ranibizumab treatment in different morphological variants of Diabetic Macular Oedema.Timepoint: 12 Months
- Secondary Outcome Measures
Name Time Method Evaluate the mean change of BCVA on ETDRS after injection for 12 months on a monthly basis, evaluate the changes in intraretinal thickness and morphology in OCT; incidence and type of any clinical or lab adverse experiences.Timepoint: 12 Months