account_circleRecruiting
Neovascular Glaucoma
Bayer Identifier:
21220
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to learn more about safety of aflibercept injection in Japanese patients with neovascular glaucoma (NVG)
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).
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).
Key Participants Requirements
Sex
AllAge
NaN - N/ATrial summary
Enrollment Goal
480Trial Dates
November 2020 - June 2028Phase
N/ACould I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Japan |
Primary Outcome
- The number of participants with adverse events (AEs)date_rangeTime Frame:Up to 6 months
Secondary Outcome
- Intraocular Pressure (IOP) value after study drug administrationIn case of transient and/or persistent IOP elevationdate_rangeTime Frame:Up to 6 months
- Mean changes in Visual Acuitydate_rangeTime Frame:Up to 6 months
- Proportion of participants with improvement of anterior neovascularizationdate_rangeTime Frame:Up to 6 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A