To collect safety data in patients with Wet-AMD after giving aflibercept injection in affected eye.
Phase 4
- Registration Number
- CTRI/2017/12/010876
- Lead Sponsor
- Bayer Pharmaceutical Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Decision to treat with intravitreal aflibercept
injection prior to patient enrolment as per the treating ophthalmologistââ?¬•s routine clinical practice.
2 Adult patients with a diagnosis of wet AMD, as
an indication approved by the local health authorities
(DCGI) for use with intravitreal aflibercept injection.
3 Patient or legal delegate signed informed
consent.
Exclusion Criteria
1. Participation in a clinical trial of an
investigational agent within 30 days
2. Patients receiving other anti-VEGF agent in
fellow eye.
3. Contraindications according to the local
prescribing information.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Frequency of reported ocular and non-ocular adverse events during observation period <br/ ><br>2 Percentage of reported ocular and non-ocular adverse events during observation periodTimepoint: 1 Frequency of reported ocular and non-ocular adverse events during observation period <br/ ><br>2 Percentage of reported ocular and non-ocular adverse events during observation period
- Secondary Outcome Measures
Name Time Method 1 Type of ocular tests undertaken <br/ ><br>2 Interval between ocular test <br/ ><br>3 Date of aflibercept injections <br/ ><br>4 Injection dose, Interval (days) between aflibercept injections,Frequency of monitoring clinic visits <br/ ><br>Timepoint: 1 Up to 6 months <br/ ><br>2 Up to 6 months <br/ ><br>3 Up to 6 months <br/ ><br>4 Up to 6 months