Wet Macular DegenerationPERSEUS-ITNCT02289924
Aflibercept (Eylea) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Italy.
Trial summary
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 912 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2015to 8 Jul 2019
- 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: wet AMD (wet age-related macular degeneration) patients
Who may be able to join
- "Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
Who cannot join
- Exclusion criteria as listed in the local SPC. 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.
- Any prior or concomitant therapy with another drug for wAMD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERSEUS-IT. A Prospective Non-intERventional Study to asSEss the Effectiveness of Aflibercept (Eylea®) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy
The main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- wet AMD
- Medical subject headings
- Wet 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
Administration by intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy 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 from baseline to 12 months.
Measured: Baseline to 12 months
Mean change of visual acuity from baseline to 24 months.
Measured: Baseline to 24 months
Secondary outcomes (13)
Number of clinical visits (visits for injections)
Measured: At 12 and 24 months
Number of monitoring visits (visits only for diagnostic purposes, but without injections)
Measured: At 12 and 24 months
Number of combined visits (visits for monitoring and injection)
Measured: At 12 and 24 months
Number of post-injection monitoring visits (visits only for safety checks after injection)
Measured: At 12 and 24 months
Number of visits outside the study center after 12 and 24 months
Measured: At 12 and 24 months
Number of optical coherence tomography (OCT) assessments per patient
Measured: At 12 and 24 months
Number of visual acuity tests
Measured: At 12 and 24 months
Number of fundoscopy examinations
Measured: At 12 and 24 months
Mean time between the injections and visits
Measured: At 12 and 24 months
Mean time between the first symptoms and diagnosis
Measured: Up to 24 months
Mean time from indication of the Eylea treatment by the treating physician to treatment
Time will be defined as difference in days between clinical indication for the treatment and the first injection
Measured: Up to 24 months
Proportion of patients with no fluid
Measured: At 4,12 and 24 months
Mean change in retinal thickness from baseline
As measured by OCT (SD-SLO) Optical Coherence Tomography ( Spectral Domain / Scanning Laser Ophthalmoscope)
Measured: Baseline and at 4,12 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 posted13 Nov 2014 (estimated)
- Study start9 Jan 2015
- Primary completion28 Mar 2019
- Study completion8 Jul 2019
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 Wet 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
- 912 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289924
- Sponsor's protocol ID
- 17634
- Other IDs
- EY1415IT
- Acronym
- PERSEUS-IT
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2014
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Nicolo M, Ciucci F, Nardi M, Parolini B, Russo A, Scupola A, Torregrossa S, Vadala M; PERSEUS-IT study investigators. PERSEUS-IT 24-month analysis: a prospective observational study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Italy in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3185-3195. doi: 10.1007/s00417-022-05679-6. Epub 2022 May 5.
PubMed 35511286
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
- PERSEUS-IT. A Prospective Non-intERventional Study to asSEss the Effectiveness of Aflibercept (Eylea®) in roUtine Clinical Practice in patientS With Wet Age-related Macular Degeneration in Italy
- ClinicalTrials.gov ID
- NCT02289924
- Acronym / sponsor ID
- PERSEUS-IT / 17634
- Conditions
- Wet Macular Degeneration
- Keywords
- wet AMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 912 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2015 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 13 Nov 2014 (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 main objectives of this non-interventional cohort field study are to evaluate effectiveness of Eylea and to describe follow-up as well as treatment patterns in patients with wAMD (wet age-related macular degeneration) in routine clinical practice in Italy for a study population of "naïve" patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)According to the recommendations of the Summary of Product Characteristics (SmPC) in Italy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- wet AMD (wet age-related macular degeneration) patients
Key inclusion criteria (1 listed)
- "Naïve" patients with wet AMD(age-related macular degeneration) treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC).
Key exclusion criteria (3 listed)
- Exclusion criteria as listed in the local SPC. 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.
- Any prior or concomitant therapy with another drug for wAMD.
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)Administration by intravitreal injection | Drug | Cohort 1 |
Primary outcome
Mean change of visual acuity from baseline to 12 months.
Time frame: Baseline to 12 months
Mean change of visual acuity from baseline to 24 months.
Time frame: Baseline to 24 months
13 secondary outcomes
Number of clinical visits (visits for injections)
Time frame: At 12 and 24 months
Number of monitoring visits (visits only for diagnostic purposes, but without injections)
Time frame: At 12 and 24 months
Number of combined visits (visits for monitoring and injection)
Time frame: At 12 and 24 months
Number of post-injection monitoring visits (visits only for safety checks after injection)
Time frame: At 12 and 24 months
Number of visits outside the study center after 12 and 24 months
Time frame: At 12 and 24 months
Number of optical coherence tomography (OCT) assessments per patient
Time frame: At 12 and 24 months
Number of visual acuity tests
Time frame: At 12 and 24 months
Number of fundoscopy examinations
Time frame: At 12 and 24 months
Mean time between the injections and visits
Time frame: At 12 and 24 months
Mean time between the first symptoms and diagnosis
Time frame: Up to 24 months
Mean time from indication of the Eylea treatment by the treating physician to treatment
Time frame: Up to 24 months
Proportion of patients with no fluid
Time frame: At 4,12 and 24 months
Mean change in retinal thickness from baseline
Time frame: Baseline and at 4,12 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 7 Nov 2023.
- Results publication: PubMed 35511286Nicolo M, Ciucci F, Nardi M, Parolini B, Russo A, Scupola A, Torregrossa S, Vadala M; PERSEUS-IT study investigators. PERSEUS-IT 24-month analysis: a prospective observational study to assess the effectiveness of intravitreal aflibercept in routine clinical practice in Italy in patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2022 Oct;260(10):3185-3195. doi: 10.1007/s00417-022-05679-6. Epub 2022 May 5.
Related trials for Wet Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer and Tabirafusp Tedromer Compared to Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) - DAYBREAK
Wet Age-related Macular Degeneration
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
RecruitingPhase 1
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
nAMD
RecruitingPhase 2
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
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 Macular Degeneration, run by Bayer at 1 site in Italy.
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 1 inclusion and 3 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 Italy. 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 from baseline to 12 months. (time frame: Baseline to 12 months). The study lists 2 primary outcomes in all. 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 NCT02289924, 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.