Safety assessment of Aflibercept injection in Japanese patients with neovascular glaucoma
Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
This study is testing if Aflibercept can safely help Japanese patients with neovascular glaucoma over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT04519619 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Aflibercept (Eylea) in treating Japanese patients diagnosed with neovascular glaucoma. It will involve a multi-center approach, where 480 patients will be recruited and followed for six months after starting treatment. Data will be collected through routine clinical visits, allowing investigators to monitor patient outcomes in real-world settings. The study is designed to provide insights into the safety profile of Eylea as used in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are Japanese patients diagnosed with neovascular glaucoma who have received Aflibercept treatment.
Not a fit: Patients with contraindications to Aflibercept or those diagnosed with other indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the safety and effectiveness of Eylea for patients with neovascular glaucoma.
How similar studies have performed: While this study is observational, similar studies assessing the safety of Aflibercept have shown promising results in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Multiple Locations
- Many locations — Multiple Locations, Japan (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.