Clinical trial NCT03290794: 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
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously treated with any systemic or other intravitreal anti-VEGF treatment will be included in this study after the window period of 30 days to avoid the risks of unknown additive effects that might be associated with previous anti-VEGF treatments .

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

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: Frequency of reported ocular and non-ocular adverse events during observation period
timeFrame: Up to 6 months
measure: Percentage of reported ocular and non-ocular adverse events during observation period
timeFrame: Up to 6 months
Secondary outcomes:
measure: Type of ocular tests undertaken
timeFrame: Up to 6 months
measure: Interval between ocular test
timeFrame: Up to 6 months
measure: Date of aflibercept injections
timeFrame: Up to 6 months
measure: Injection dose
timeFrame: Up to 6 months
measure: Interval (days) between aflibercept injections
timeFrame: Up to 6 months
measure: Frequency of monitoring / clinic visits
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: India
facility: Many Locations
Study officials:
References: