Macular DegenerationNCT01783925
Eylea Post Marketing Surveillance(PMS)
An observational study of Macular Degeneration, run by Bayer at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- How many people
- 3,206 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2014to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Eylea Post Marketing Surveillance
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
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Drug
Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) [including serious adverse events (SAEs) and ocular AEs, especially AEs due to intravitreal injection procedure] and adverse drug reactions (ADRs)
Measured: 4 months
Secondary outcomes (6)
Measurement of BCVA (prior to injection and performing other ocular assessments) by eye chart. [BCVA: Best Corrected Visual Acuity]
Measured: 4 months or 8 months
Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
Measured: 4 months or 8 months
Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
Measured: 4 months or 8 months
IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
Measured: 4 months or 8 months
Measurement of fundus lesion by fundoscopy
Measured: 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)
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study start29 Apr 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783925
- Sponsor's protocol ID
- 16469
- Other IDs
- EY1310KR
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2013
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35256840
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eylea Post Marketing Surveillance
- ClinicalTrials.gov ID
- NCT01783925
- Acronym / sponsor ID
- 16469
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,206 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by MFDS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- Patients who have received anti-VEGF therapy within 90 days
- Patients who are contraindicated based on the approved product label
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label. | Drug | Group 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)
Time frame: 4 months
6 secondary outcomes
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
Central retinal thickness by OCT with or without.[OCT: Optical Coherence Tomography]
Time frame: 4 months or 8 months
Findings of FAG and/or ICAG. [FAG: Fluorescein Angiography].ICAG: Indocyanine Green Angiography]
Time frame: 4 months or 8 months
IOP(if performed, before/after injection).[IOP: Intra Ocular Pressure]
Time frame: 4 months or 8 months
Measurement of fundus lesion by fundoscopy
Time frame: 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)
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Results publication: PubMed 35256840Shimura 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.
Related trials for Macular Degeneration
RecruitingPhase 2
An Open-Label Phase 2 Study of N-Acetyl-D-Mannosamine (ManNAc) in Subjects With Podocyte Diseases
Focal Segmental Glomerulosclerosis, Minimal Change Disease
RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity
Lymphoproliferative Disorder, HHV-8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Bayer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783925, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.