Trial Condition(s):
Neovascular Glaucoma
Study to learn more about safety of aflibercept injection in Japanese patients with neovascular glaucoma (NVG)
Bayer Identifier:
21220
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Japan | Status Recruiting | Contact Us: E-mail: clinical-t[email protected] Phone: (+)1-888-84 22937 |
Trial Design
Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
Trial Type:
Observational
Intervention Type:
N/A
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The number of participants with adverse events (AEs)Timeframe: Up to 6 months
Secondary Outcome
- Intraocular Pressure (IOP) value after study drug administrationIn case of transient and/or persistent IOP elevationTimeframe: Up to 6 months
- Mean changes in Visual AcuityTimeframe: Up to 6 months
- Proportion of participants with improvement of anterior neovascularizationTimeframe: Up to 6 months
Additional Information
Not Available
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