Wet Age-related Macular DegenerationPERSEUSNCT01914380
Investigating the Effectiveness of Eylea in Patients With Wet Age-related Macular Degeneration
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 1 site in Germany.
Trial summary
The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- How many people
- 988 participants
- Where
- 1 siteGermany
- Study dates
- 29 Jul 2013to 31 Mar 2017
- 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: The study population will consist of patients with wAMD treated with Eylea. Participants will be recruited from ophthalmological clinics and practices throughout Germany. The decision upon treatment is made at the discretion of the attending physician, according to his/her medical practice. The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
Who may be able to join
- Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
- Written informed consent.
Who cannot join
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Any concomitant therapy with another agent to treat wet AMD in the study eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration
The study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Wet age-related macular degeneration, Anti-VEGF-Therapy, Observational study
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 will be followed-up for 24 months
| 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.
Mean change of visual acuity for the total patient population
Measured: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients
Measured: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients
Measured: Baseline, 12 and 24 months
Secondary outcomes (3)
Monitoring of disease activity
Monitoring of disease activity in routine clinical practice setting will be assessed e.g. by determining the o No. of clinical visits (visits for injections) o No. of monitoring visits (visits only for diagnostic purposes, but without injections) o No. of safety visits after the injection (visits only for safety checks after injection) o No. of visits outside the study center o No. of OCT (optical coherence tomography) assessments per patient after 12 and 24 months
Measured: after 12 and 24 months
Monitoring of treatment patterns
same assessment as indicated for "Monitoring of disease activity"
Measured: after 12 and 24 months
Mean time from indication of Eylea-treatment by the treating physician to start of treatment
Measured: after 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study start29 Jul 2013
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age-related 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
- 988 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
- NCT01914380
- Sponsor's protocol ID
- 16623
- Other IDs
- EY1313DE
- Acronym
- PERSEUS
- Status last verified
- Mar 2018
- First submitted
- 23 Jul 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERSEUS - A Prospective Non-interventional Study to Assess the Effectiveness of Aflibercept (Eylea®) in Routine Clinical Practice in Patients With Wet Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01914380
- Acronym / sponsor ID
- PERSEUS / 16623
- Conditions
- Wet Age-related Macular Degeneration
- Keywords
- Wet age-related macular degeneration, Anti-VEGF-Therapy, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 988 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 29 Jul 2013 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 2 Aug 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 study aims to investigate the effectiveness of Eylea in patients with wet age-related macular degeneration in routine clinical practice in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
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
- The study population will consist of patients with wAMD treated with Eylea. Participants will be recruited from ophthalmological clinics and practices throughout Germany. The decision upon treatment is made at the discretion of the attending physician, according to his/her medical practice. The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.
Key inclusion criteria (2 listed)
- Patients with wet wAMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
- Written informed consent.
Key exclusion criteria (2 listed)
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
- Any concomitant therapy with another agent to treat wet AMD in the study eye.
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 will be followed-up for 24 months | Drug | Group 1 |
Primary outcome
Mean change of visual acuity for the total patient population
Time frame: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of pretreated patients
Time frame: Baseline, 12 and 24 months
Mean change of visual acuity for the subgroup of non-pretreated patients
Time frame: Baseline, 12 and 24 months
3 secondary outcomes
Monitoring of disease activity
Time frame: after 12 and 24 months
Monitoring of treatment patterns
Time frame: after 12 and 24 months
Mean time from indication of Eylea-treatment by the treating physician to start of treatment
Time frame: after 12 and 24 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 29 Mar 2018.
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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 Wet Age-related Macular Degeneration, run by Bayer at 1 site in Germany.
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 2 inclusion and 2 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 29 Mar 2018. 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 Germany. 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?
Mean change of visual acuity for the total patient population (time frame: Baseline, 12 and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2018.