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
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
The study will be multicenter, observational, prospective, single arm, post marketing surveillance study of intravitreal aflibercept injection in wet AMD patients in routine clinical practice and real-life conditions without any protocol mandated interventions.
Approximately 100 wet AMD patients from up to ten ophthalmology clinics across India will be enrolled in this study. Each study site will be requested to enroll approximately 10 patients, however, the sites will be asked to enrolled additional patients in case of failure to enroll 10 patients by other site to complete the recruitment of approximately 100 patients.
Patients will be observed for maximum period of 6 months after the start of intravitreal aflibercept treatment. The observation period should cover the entire period from initial visit to the last follow-up visit at six months or withdrawal of consent, or the patient is lost to follow up (whatever is earliest).
The study site will be asked to enroll into the study all consecutive patients with wet AMD for whom the decision has been made to treat with intravitreal aflibercept injection and patients agrees to sign informed consent form for data collection purpose.
Any switch to another therapy or initiated administration of other anti-VEGF (Vascular Endothelial Growth Factor) injection in fellow eye or the discontinuation of treatment with IVT-AFL before the 6 month implies the end of the observation period. However, the safety follow-up will continue at least 30 days after last intravitreal aflibercept injection or in case of the discontinuation of treatment with IVT-AFL or till the patient switch the treatment from IVT-AFL and received other anti-VEGF injection before the 6 month observation period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Decision to treat with intravitreal aflibercept for wet AMD Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept. |
Drug: Aflibercept (Eylea, BAY86-5321)
Intravitreal Aflibercept as prescribed by the treating Physician
|
Outcome Measures
Primary Outcome Measures
- Frequency of reported ocular and non-ocular adverse events during observation period [Up to 6 months]
unilateral / bilateral treatment
- Percentage of reported ocular and non-ocular adverse events during observation period [Up to 6 months]
unilateral / bilateral treatment
Secondary Outcome Measures
- Type of ocular tests undertaken [Up to 6 months]
e.g. Visual acuity, ocular computed tomography, indocyanine angiography, Angiography, Fundus photography
- Interval between ocular test [Up to 6 months]
Date of ocular test
- Date of aflibercept injections [Up to 6 months]
Date of aflibercept injections
- Injection dose [Up to 6 months]
Injection dose
- Interval (days) between aflibercept injections [Up to 6 months]
During observation periods
- Frequency of monitoring / clinic visits [Up to 6 months]
Frequency of monitoring / clinic visits
Eligibility Criteria
Criteria
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:
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Participation in a clinical trial of an investigational agent within 30 days.
-
Patients receiving other anti-VEGF agent in fellow eye.
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Contraindications according to the local prescribing information.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | India |
Sponsors and Collaborators
- Bayer
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19140