Eylea Post Marketing Surveillance(PMS)

NCT01783925 | Completed

• 2 other identifiers: 16469EY1310KR
• Study Type: observational
• Target: 3,206
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (1)

Group 1

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with wet age-related macular degeneration(wAMD), RVO, DME, and mCNV who are decided to receive EYLEA (VEGF Trap Eye) treatment

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Many Locations

Multiple Locations, South Korea

Location

Related 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: 10.2147/OPTH.S344194. eCollection 2022.

  PMID: 35256840 RESULT

Related Links

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

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 5, 2013
• Study Start: April 29, 2014
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

KR (1)