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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04519619
Other study ID # 21220
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2020
Est. completion date June 30, 2028

Study information

Verified date June 2024
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date June 30, 2028
Est. primary completion date June 30, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Aflibercept (Eylea, BAY86-5321)
Administration by intravitreal injection

Locations

Country Name City State
Japan Many locations Multiple Locations

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of participants with adverse events (AEs) Up to 6 months
Secondary Intraocular Pressure (IOP) value after study drug administration In case of transient and/or persistent IOP elevation Up to 6 months
Secondary Mean changes in Visual Acuity Up to 6 months
Secondary Proportion of participants with improvement of anterior neovascularization Up to 6 months
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