Clinical trial NCT01783925: Eylea Post Marketing Surveillance(PMS)
Official title: Eylea Post Marketing Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-02-05
Enrollment: 3206
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: 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
measure: Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
timeFrame: 4 months or 8 months
measure: Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
timeFrame: 4 months or 8 months
measure: IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
timeFrame: 4 months or 8 months
measure: Measurement of fundus lesion by fundoscopy
timeFrame: 4 months or 8 months
measure: 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
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.