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

NCT03290794 | Completed

• 1 other identifier: 19140
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Frequency of reported ocular and non-ocular adverse events during observation period

  unilateral / bilateral treatment

  Up to 6 months

• Percentage of reported ocular and non-ocular adverse events during observation period

  unilateral / bilateral treatment

  Up to 6 months

Secondary Outcomes (6)

• Type of ocular tests undertaken

  Up to 6 months

• Interval between ocular test

  Up to 6 months

• Date of aflibercept injections

  Up to 6 months

• Injection dose

  Up to 6 months

• Interval (days) between aflibercept injections

  Up to 6 months

Study Arms (1)

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)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

Intravitreal Aflibercept as prescribed by the treating Physician

Decision to treat with intravitreal aflibercept for wet AMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many Locations

Multiple Locations, India

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: February 14, 2019
• Primary Completion: November 25, 2022
• Study Completion: May 26, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)