Choroidal Neovascularization
Conditions
Keywords
Aflibercept, Anti-VEGF
Brief summary
The objectives of this study are to investigate the safety and effectiveness of EYLEA.
Detailed description
This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study. The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 1 years or until it is no longer possible (e.g. lost to follow-up within the 1 year ). In total, 300 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 visits and final visit, either by routine clinical visits (as per investigators routine practice) .
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Administration by intravitreal injection
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who start EYLEA treatment for mCNV(myopic choroidal neovascularization).
Exclusion criteria
* Patients who have already received EYLEA treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of episodes of Adverse drug reaction (ADR's) | Up to 12 months |
| Number of episodes of Infections | Up to 12 months |
| Number of episodes of Serious Adverse Events(SAE's) | Up to 12 months |
| Number of episodes of Ocular Adverse events | Up to 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean changes in visual acuity | Baseline up to 12 months |
| Mean changes in retina thickness | Baseline up to 12 months |
Countries
Japan
Outcome results
None listed