Macular Degeneration
Conditions
Brief summary
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
Interventions
DRUGAflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients determined to start EYLEA treatment * Patients who agree and sign informed consent * Patients who receive EYLEA treatment for the first time * Patients who meet one of the following * Patients diagnosed by physician as having neovascular (wet) age-related macular degeneration wAMD * Patients diagnosed by physician as having visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) * Patients diagnosed as having visual impairment due to diabetic macular edema (DME) * Patients diagnosed as having visual impairment due to myopic choroidal neovascularization (mCNV)
Exclusion criteria
* Patients who have received anti-VEGF therapy within 90 days * Patients who are contraindicated based on the approved product label * Ocular or periocular infection * Active severe intraocular inflammation * Known hypersensitivity to any ingredient of this drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity] | 4 months or 8 months |
| Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography] | 4 months or 8 months |
| Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography] | 4 months or 8 months |
| IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure] | 4 months or 8 months |
| Measurement of fundus lesion by fundoscopy | 4 months or 8 months |
| Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs) | 8 months |
Countries
South Korea
Outcome results
None listed