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NCT Number: NCT04519619

Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With 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).

Recruiting

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Key information

Conditions

Neovascular Glaucoma Eye Diseases Glaucoma Glaucoma, Neovascular Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Japan

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

Administration by intravitreal injection

Primary outcomes

  1. The number of participants with adverse events (AEs)

    Time frame: Up to 6 months

Secondary outcomes

  1. Intraocular Pressure (IOP) value after study drug administration

    Time frame: Up to 6 months

    In case of transient and/or persistent IOP elevation

  2. Mean changes in Visual Acuity

    Time frame: Up to 6 months

  3. Proportion of participants with improvement of anterior neovascularization

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bayer Clinical Trials Contact

CONTACT

[email protected]

(+)1-888-84 22937

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)

Important dates

Study start
2020
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2020
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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