Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
- Registration Number
- NCT04519619
- Lead Sponsor
- Bayer
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Diagnosis of NVG
- Patients who have received IVT-AFL treatment according to Japanese labeling.
- Patients who are contraindicated based on approved label
- Diagnosis of other indication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Aflibercept (Eylea, BAY86-5321) Aflibercept (Eylea, BAY86-5321) Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert
- Primary Outcome Measures
Name Time Method The number of participants with adverse events (AEs) Up to 6 months
- Secondary Outcome Measures
Name Time Method Intraocular Pressure (IOP) value after study drug administration Up to 6 months In case of transient and/or persistent IOP elevation
Mean changes in Visual Acuity Up to 6 months Proportion of participants with improvement of anterior neovascularization Up to 6 months
Trial Locations
- Locations (1)
Many locations
🇯🇵Multiple Locations, Japan