CTRI/2015/06/005945
Completed
Phase 4
A multi-center, open-label, observational study to evaluate the efficacy and safety of intravitreal injections (IVI) of Ranibizumab in patients with visual impairment due to Diabetic Macular Edema (DME) - UNVEIL- DME
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Patients with visual impairment due to Diabetic Macular Edema
- Sponsor
- ovartis Healthcare Pvt Ltd
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients willing to provide signed, written informed consent
- •2\.Patients with macular edema due to Diabetes (confirmed by fundus photography, fluorescein angiography, OCT)
- •3\.Male and female aged 18 and above.
- •4\.Vision Impairment due to DME (PL \+ to 6/9 on Snellen chart).
Exclusion Criteria
- •1\. Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment.
- •2\. Active intraocular inflammation in either eye.
- •3\. Uncontrolled glaucoma in the study eye.
- •4\. Active proliferative diabetic retinopathy in the study eye.
- •5\. Any contra\-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of ranibizumab.
Outcomes
Primary Outcomes
Not specified
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