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

Sponsor
Bayer
Study ID
NCT04519619
Status
Recruiting

Conditions

  • Neovascular Glaucoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Nov 27, 2020
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
480 participants (estimated)

Arms

  • Arm: Aflibercept (Eylea, BAY86-5321)
    Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert

Primary Outcome Measure

The number of participants with adverse events (AEs) [ Time Frame: Up to 6 months ]

Central Contacts