Macular DegenerationGALAXYNCT03521895
An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies
An observational study of Macular Degeneration, run by Bayer at 1 site in Germany.
Trial summary
The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2018to 30 Nov 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: This integrated analysis will include only treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW.
Who may be able to join
- PERSEUS
- Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC)
- Documentation of at least one Aflibercept (Eylea) injection
- Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW
- Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
- Patient who meet the local indication criteria for Eylea treatment
Show all 12Show fewer
- At least one BCVA after the 1st Eylea injection
- BCVA at baseline
- Patient with no history of retinal disease
- Patient not previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye (for fellow eye allowed).
- For patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. If both eyes are treated during initial visit, the treated eye with worst Best-Corrected Visual Acuity (BCVA) at M0 will be retained. If the two conditions are similar the study eye is the Right eye by convention
- Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled Exclusion criteria PERSEUS
Who cannot join
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- All patients previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye will additionally be excluded for this integrated analysis
- Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW
- Patient who does not meet the local indication criteria for Eylea treatment. Contraindications listed in the SmPCs must be taken into account
- Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
- Patient who has previously been treated with any macular laser (laser and/or visudyne/PDT) or any anti-VEGF intravitreal injections for the study eye
- Patient taking part in an interventional study at the time of enrolment
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS.
The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.
- Conditions
- Macular Degeneration
- Being tested
- Eylea (Aflibercept, 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.
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Drug
Patients observed with regular and irregular treatment course
| Study group | Role | What they receive |
|---|---|---|
| Treatment naïve wAMD | Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW Receives: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline
Measured: At baseline and 12 months
Secondary outcomes (5)
Mean time from diagnosis by the treating physician to start of treatment
Measured: At baseline
Proportion of patients gaining 5, 10 or 15 or more letters
Measured: At 12 months
Proportion of patients with ≥70 letters VA
Measured: At 12 months
Proportion of patients with ≥73 letters VA
Measured: At 12 months
Proportion of patients losing 5, 10 or 15 or more letters
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 May 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521895
- Sponsor's protocol ID
- 19694
- Acronym
- GALAXY
- Status last verified
- Jan 2020
- First submitted
- 30 Apr 2018
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Analysis of the Effectiveness of Intravitreal (IVT) Aflibercept (Eylea) in Routine Clinical Practice Based on Two Large Observational Studies
- ClinicalTrials.gov ID
- NCT03521895
- Acronym / sponsor ID
- GALAXY / 19694
- Conditions
- Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 11 May 2018 (actual)
- 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 aim of this integrated analysis is to describe the effectiveness of Eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies RAINBOW and PERSEUS.
The primary objective of this integrated analysis is to describe the effectiveness of Eylea on the mean change from baseline in visual acuity (VA) at 12 months in Wet age-related macular degeneration (wAMD) treatment naïve patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment naïve wAMD | – | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This integrated analysis will include only treatment naïve patients with wAMD treated with IVT aflibercept from the two underlying studies PERSEUS and RAINBOW.
Key inclusion criteria (12 listed)
- PERSEUS
- Patients with wet AMD treated with Eylea (in accordance with the local Summary of Product Characteristics, SPC)
- Documentation of at least one Aflibercept (Eylea) injection
- Assessment of at least one visual acuity measurement with available VA letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available VA letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection RAINBOW
- Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
Key exclusion criteria (7 listed)
- Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
- All patients previously treated with any macular laser or any anti-VEGF intravitreal injections for the study eye will additionally be excluded for this integrated analysis
- Any concomitant therapy with another agent to treat wet AMD in the study eye RAINBOW
- Patient who does not meet the local indication criteria for Eylea treatment. Contraindications listed in the SmPCs must be taken into account
- Patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks
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 |
|---|---|---|
| Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Patients observed with regular and irregular treatment course | Drug | Treatment naïve wAMD |
Primary outcome
Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline
Time frame: At baseline and 12 months
5 secondary outcomes
Mean time from diagnosis by the treating physician to start of treatment
Time frame: At baseline
Proportion of patients gaining 5, 10 or 15 or more letters
Time frame: At 12 months
Proportion of patients with ≥70 letters VA
Time frame: At 12 months
Proportion of patients with ≥73 letters VA
Time frame: At 12 months
Proportion of patients losing 5, 10 or 15 or more letters
Time frame: At 12 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 10 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 12 inclusion and 7 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 10 Jan 2020. 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?
Absolute difference in visual acuity (VA) change from baseline will be calculated for each patient as: VA letter score at month 12 - VA letter score at baseline (time frame: At baseline and 12 months). 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 10 Jan 2020.