A observational study to evaluate the efficacy and safety of Ranibizumab in patients with visual impairment due to Diabetic Macular Edema(DME
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with visual impairment due to Diabetic Macular Edema
- Registration Number
- CTRI/2015/06/005945
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate efficacy of ranibizumab 0.5 mg in management of DME in terms of mean change from baseline in BCVA over a 48 week treatment period.Timepoint: over a 48 week treatment period
- Secondary Outcome Measures
Name Time Method 1) To evaluate the mean change of Best corrected Visual acuity after injection of Ranibizumab 0.5 mg <br/ ><br>2) To evaluate the change in intraretinal thickness in Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks & 48 weeks <br/ ><br>3) To evaluate the progression of avascular area by fluorescein angiography (FA) after 12 weeks, 24 weeks & 48 weeks. <br/ ><br>4) To evaluate the number of injections for treatment. <br/ ><br>5) To evaluate other ocular & systemic safety issues. <br/ ><br>Timepoint: over a 48 week treatment period