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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | Drug | Administration by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants with adverse events (AEs) | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) value after study drug administration | In case of transient and/or persistent IOP elevation | Up to 6 months |
| Mean changes in Visual Acuity | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator.
Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | (+)1-888-84 22937 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Recruiting | Multiple Locations | Japan |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| ID | Term |
|---|---|
| D015355 | Glaucoma, Neovascular |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Proportion of participants with improvement of anterior neovascularization | Up to 6 months |