Eylea Post Marketing Surveillance(PMS)

Macular Degeneration Clinical Trial

Official title:

Eylea Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783925
• Other study ID #: 16469
• Secondary ID: EY1310KR
• Status: Completed
• Start date: April 29, 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3206
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

Locations

Country	Name	City	State
Korea, Republic of	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Shimura M, Fukumatsu M, Tsujimura J, Hirano K, Sunaya T; Participating Investigators. Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes. Clin Ophthalmol. 2022 Mar 1;16:579-592. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]		4 months or 8 months
Secondary	Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]		4 months or 8 months
Secondary	Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]		4 months or 8 months
Secondary	IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]		4 months or 8 months
Secondary	Measurement of fundus lesion by fundoscopy		4 months or 8 months
Secondary	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

External Links

•   Click here to find further information and, after study completion, the study results according to Bayer's transparency standards