Trial Condition(s):
Macular degeneration
Eylea Post Marketing Surveillance(PMS)
Bayer Identifier:
16469
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
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
Trial Summary
Enrollment Goal
3206
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Many Locations Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Eylea Post Marketing Surveillance
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)Timeframe: 4 months
Secondary Outcome
- Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]Timeframe: 4 months or 8 months
- Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]Timeframe: 4 months or 8 months
- Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]Timeframe: 4 months or 8 months
- IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]Timeframe: 4 months or 8 months
- Measurement of fundus lesion by fundoscopyTimeframe: 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)Timeframe: 8 months
Additional Information
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