An observational study to assess the profile of ranibizumab in patients with retinal vein occlusion in a real-world setting.
Phase 4
Completed
- Conditions
- Health Condition 1: null- Patients with visual impairment due to macular edema secondary to retinal vein occlusion (RVO)
- Registration Number
- CTRI/2015/07/005985
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Patients willing to provide signed written informed consent.
2. Male and female aged 18 years and above.
3. Patients with macular edema due to BRVO and CRVO (confirmed by fundus photography, fluorescein angiography, OCT).
4. Baseline best-corrected visual acuity (BCVA) in the study eye from perception of light + (PL+) to 6/9 on Snellen chart
Exclusion Criteria
1. Additional eye disease that could compromise VA
2. Active intraocular inflammation in either eye
3. Uncontrolled glaucoma in the study eye
4. Intraocular surgery <=1 month before day 0
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 the efficacy of ranibizumab 0.5 mg IVI in management of RVO in terms of mean change from baseline in Best Corrected Visual Acuity (BCVA) over a 48 week treatment period. <br/ ><br> <br/ ><br>Timepoint: over a 48 week treatment period treatment period. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method <br/ ><br>To evaluate : <br/ ><br> <br/ ><br>1)the mean change of Best corrected Visual acuity (BCVA) after injection of Ranibizumab <br/ ><br>2)the change from baseline in central retinal thickness as measured by Optical Coherence Tomography (OCT) after 12 weeks, 24 weeks and 48 weeks. <br/ ><br>c)the progression of avascular area as measured by fluorescein angiography (FA) after 12 weeks, 24 weeks and 48 weeks. <br/ ><br>4)the number of injections used for treatment. <br/ ><br>5)other ocular and systemic safety issues.Timepoint: over a 48 week treatment period