Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aflibercept (Eylea, BAY86-5321).
- Who it may be relevant to
- Registry conditions: Neovascular Glaucoma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
Overview
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
- Drug Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection
Primary outcome measures
- The number of participants with adverse events (AEs) [Time frame: Up to 6 months]
Secondary outcome measures (3)
- Intraocular Pressure (IOP) value after study drug administration [Time frame: Up to 6 months]
- Mean changes in Visual Acuity [Time frame: Up to 6 months]
- Proportion of participants with improvement of anterior neovascularization [Time frame: Up to 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Japan · 1 center
- Many locations — Multiple Locations
Identifiers
NCT: NCT04519619 · 21220