Trial Condition(s):
Wet age-related macular degeneration
Structured Post-marketing surveillance to collect the safety data of intravitreal aflibercept injection (IVT-AFL) in patients of wet age-related macular degeneration during real world clinical practice
Bayer Identifier:
19140
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The proposed regulatory post-marketing surveillance (PMS) study will be planned to collect the safety data of aflibercept intravitreal injection in patients with wet Age-related Macular Degeneration (AMD) in real-life treatment practice
The primary objective is:
- To collect safety data in wet AMD patients treated with intravitreal aflibercept injection
The secondary objective is:
- To determine how disease activity is monitored including type and frequency of ocular tests and frequency of injections
Inclusion Criteria
- Decision to treat with intravitreal aflibercept injection prior to patient enrolment as per the treating ophthalmologist’s routine clinical practice. - Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities (DCGI) for use with intravitreal aflibercept injection. - Patient or legal delegate signed informed consent.
Exclusion Criteria
- Participation in a clinical trial of an investigational agent within 30 days. - Patients receiving other anti-VEGF agent in fellow eye. - Contraindications according to the local prescribing information.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, India | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Structured Post-marketing surveillance to collect the safety data of intravitreal aflibercept injection (IVT-AFL) in patients of wet age-related macular degeneration during real world clinical practice
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Frequency of reported ocular and non-ocular adverse events during observation periodunilateral / bilateral treatmentTimeframe: Up to 6 months
- Percentage of reported ocular and non-ocular adverse events during observation periodunilateral / bilateral treatmentTimeframe: Up to 6 months
Secondary Outcome
- Type of ocular tests undertakene.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photographyTimeframe: Up to 6 months
- Interval between ocular testDate of ocular testTimeframe: Up to 6 months
- Date of aflibercept injectionsDate of aflibercept injectionsTimeframe: Up to 6 months
- Injection doseInjection doseTimeframe: Up to 6 months
- Interval (days) between aflibercept injectionsDuring observation periodsTimeframe: Up to 6 months
- Frequency of monitoring / clinic visitsFrequency of monitoring / clinic visitsTimeframe: Up to 6 months
Additional Information
Copyright © Bayer
Powered by
