Study Completed

Macular Degeneration

Bayer Identifier:

16469

ClinicalTrials.gov Identifier:

NCT01783925

EudraCT Number:

Not Available

EU CT Number:

Not Available

Eylea Post Marketing Surveillance(PMS)

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

Key Participants Requirements

Sex

Both

Age

NaN - N/A

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

April 2014 - December 2018

Phase

N/A

Could I Receive a placebo

Products

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

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Korea, Republic Of

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)
Time Frame:
4 months
Safety Issue:
Yes

Secondary Outcome

Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]
Time Frame:
4 months or 8 months
Safety Issue:
No
Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
Time Frame:
4 months or 8 months
Safety Issue:
No
Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
Time Frame:
4 months or 8 months
Safety Issue:
No
IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
Time Frame:
4 months or 8 months
Safety Issue:
No
Measurement of fundus lesion by fundoscopy
Time Frame:
4 months or 8 months
Safety Issue:
No
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
Time Frame:
8 months
Safety Issue:
Yes

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

N/A

Additional Information

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