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

Neovascular Glaucoma Clinical Trial

Official title:

Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04519619
• Other study ID #: 21220
• Status: Recruiting
• Start date: November 27, 2020
• Est. completion date: June 30, 2028

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: Bayer Clinical Trials Contact
• Phone: (+)1-888-84 22937
• Email: clinical-trials-contact[@]bayer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection

Locations

Country	Name	City	State
Japan	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants with adverse events (AEs)		Up to 6 months
Secondary	Intraocular Pressure (IOP) value after study drug administration	In case of transient and/or persistent IOP elevation	Up to 6 months
Secondary	Mean changes in Visual Acuity		Up to 6 months
Secondary	Proportion of participants with improvement of anterior neovascularization		Up to 6 months