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

Completed

• Conditions: Wet Age-related Macular Degeneration
• Interventions: Drug: Aflibercept (Eylea, BAY86-5321)

• Registration Number: NCT03290794
• Lead Sponsor: Bayer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2019-02-14
• Primary Completion: 2022-11-25
• Study Completion: 2023-05-26
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Decision to treat with intravitreal aflibercept for wet AMD	Aflibercept (Eylea, BAY86-5321)	Adult patients with a diagnosis of wet AMD, as an indication approved by the local health authorities for use with intravitreal aflibercept.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Many Locations; 🇮🇳 Multiple Locations, India