Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)

Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)

This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.

The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).

Study Overview

• Status: Recruiting
• Conditions: Neovascular Glaucoma
• Intervention / Treatment: Drug: Aflibercept (Eylea, BAY86-5321)

• Study Type: Observational
• Enrollment (Estimated): 480

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• Japan
  • Multiple Locations, Japan
    • Recruiting
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator.

Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.

Description

Inclusion Criteria:

• Diagnosis of NVG
• Patients who have received IVT-AFL treatment according to Japanese labeling.

Exclusion Criteria:

• Patients who are contraindicated based on approved label
• Diagnosis of other indication

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aflibercept (Eylea, BAY86-5321); Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert	Drug: Aflibercept (Eylea, BAY86-5321); Administration by intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The number of participants with adverse events (AEs)	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP) value after study drug administration	In case of transient and/or persistent IOP elevation	Up to 6 months
Mean changes in Visual Acuity		Up to 6 months
Proportion of participants with improvement of anterior neovascularization		Up to 6 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Neovascular; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 21220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No