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
- Aflibercept (Eylea, BAY86-5321) — DRUGAdministration by intravitreal injection
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
- Bayer Clinical Trials Contact(+)1-888-84 22937