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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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04519619
Enrollment
480
Registered
2020-08-19
Start date
2020-11-27
Completion date
2028-06-30
Last updated
2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Glaucoma

Brief summary

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).

Interventions

Administration by intravitreal injection

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of participants with adverse events (AEs)Up to 6 months

Secondary

MeasureTime frameDescription
Intraocular Pressure (IOP) value after study drug administrationUp to 6 monthsIn case of transient and/or persistent IOP elevation
Mean changes in Visual AcuityUp to 6 months
Proportion of participants with improvement of anterior neovascularizationUp to 6 months

Countries

Japan

Contacts

CONTACTBayer Clinical Trials Contact
clinical-trials-contact@bayer.com(+)1-888-84 22937

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026