Clinical trial

Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)

Name
21220
Description
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).
Trial arms
Trial start
2020-11-27
Estimated PCD
2027-06-30
Trial end
2028-06-30
Status
Recruiting
Treatment
Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection
Arms:
Aflibercept (Eylea, BAY86-5321)
Size
480
Primary endpoint
The number of participants with adverse events (AEs)
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 480, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

1 product

1 indication

Organization
Bayer