Wet Macular DegenerationRAINBOWNCT02279537
Real Life of Aflibercept In FraNce: oBservatiOnnal Study in Wet AMD
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in France.
Trial summary
The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 593 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2014to 17 Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Naïve treatment patients with wet AMD who started a treatment with Anti VEGF (Vascular Endothelial Growth Factor) may be included in the study
Who may be able to join
- Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
- Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
- Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
- Man or woman aged 18 years or more
- Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;
Who cannot join
- 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 does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
- 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
Official title: A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept
The purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated
Read the detailed description
The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.
Patients will be followed up for a period of 48 months or until it is no longer possible
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Wet age-related macular Degeneration (Wet-AMD), Naïve patients, Real life, Aflibercept
- 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) 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.
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
Measured: Baseline to 12 months
Secondary outcomes (3)
Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit
Measured: Baseline to 2 year, 3 year, 4 year
Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)
Measured: Baseline to 1 year, 2 year, 3 year, 4 year
Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit
Measured: Baseline to 1 year, 2 year, 3 year, 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start2 Jan 2014
- Primary completion17 Apr 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Other
- Enrolment
- 593 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
- NCT02279537
- Sponsor's protocol ID
- 17374
- Other IDs
- EY1411FR
- Acronym
- RAINBOW
- Status last verified
- Nov 2023
- First submitted
- 29 Oct 2014
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):959-969. doi: 10.1007/s00417-022-05900-6. Epub 2022 Nov 18.
PubMed 36399178Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020 Apr 6;5(1):e000377. doi: 10.1136/bmjophth-2019-000377. eCollection 2020.
PubMed 32518833Weber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020 May 25;20(1):206. doi: 10.1186/s12886-020-01468-z.
PubMed 32450838Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY; RAINBOW study investigators. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019 Apr 9;4(1):e000109. doi: 10.1136/bmjophth-2017-000109. eCollection 2019.
PubMed 31179386
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
- A Retrospective and Prospective Non-interventional Open Label Study to Assess the Real Life of Treatment-naive Patients With Wet Age-related Macular Degeneration in Routine Clinical Practice in France and Starting an Anti VEGF Therapy With Aflibercept
- ClinicalTrials.gov ID
- NCT02279537
- Acronym / sponsor ID
- RAINBOW / 17374
- Conditions
- Wet Macular Degeneration
- Keywords
- Wet age-related macular Degeneration (Wet-AMD), Naïve patients, Real life, Aflibercept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 593 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 2 Jan 2014 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 31 Oct 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 purpose of this study is to collect real-life data on patients with wet age related macular degeneration (AMD) for whom treatment with Eylea was initiated
Detailed description
The study is both retrospective and prospective to collect local real life data on patients under routine treatment. The observation period starts on January 2014. Patients who have received the 1st injection with Eylea from January 2014 will be enrolled.
Patients will be followed up for a period of 48 months or until it is no longer possible
Study design
- Observational model
- Cohort
- Time perspective
- Other
- 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Naïve treatment patients with wet AMD who started a treatment with Anti VEGF (Vascular Endothelial Growth Factor) may be included in the study
Key inclusion criteria (5 listed)
- Patient with a diagnosis of wet AMD will be enrolled after the decision for treatment with Aflibercept (Eylea) has been made
- Patient with 1st injection of Eylea from 01 January 2014 until 30 April 2015 will be enrolled
- Prior/current treatment with any anti-VEGF intravitreal injections or macular laser (laser and/or visudyne/PDT) in the fellow eye is allowed
- Man or woman aged 18 years or more
- Patient who has been given appropriate information about the study objectives and procedures and who has given his/her written, informed consent;
Key exclusion criteria (4 listed)
- 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 does not meet the local indication criteria for Eylea treatment.Contraindications listed in the Summary of Product Characteristics (SmPC) must be taken into account
- 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.
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
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months.
Time frame: Baseline to 12 months
As assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) method or any visual logarithmic scale
3 secondary outcomes
Change in Best Corrected Visual Acuity (BCVA) during the second year and until the fourth year of treatment versus the initial visit
Time frame: Baseline to 2 year, 3 year, 4 year
Percentage of patients who experienced a gain in BCVA, from initial visit to each follow-up visit (letter score of ≥ 0 letters, ≥ 5 letters, ≥ 10 letters, ≥ 15 letters)
Time frame: Baseline to 1 year, 2 year, 3 year, 4 year
Percentage of patients losing fewer than 15 letters from the initial visit visual acuity at each follow-up visit
Time frame: Baseline to 1 year, 2 year, 3 year, 4 year
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 36399178Cohen SY, Dominguez M, Coscas F, Faure C, Baillif S, Oubraham H, Kodjikian L, Weber M; RAINBOW study investigators. Final 4-year results of the RAINBOW real-world study: intravitreal aflibercept dosing regimens in France in treatment-naive patients with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2023 Apr;261(4):959-969. doi: 10.1007/s00417-022-05900-6. Epub 2022 Nov 18.
- Derived from this study: PubMed 32518833Weber M, Kodjikian L, Coscas F, Faure C, Aubry I, Dufour I, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration in routine clinical practice in France: results from the RAINBOW study. BMJ Open Ophthalmol. 2020 Apr 6;5(1):e000377. doi: 10.1136/bmjophth-2019-000377. eCollection 2020.
- Derived from this study: PubMed 32450838Weber M, Dominguez M, Coscas F, Faure C, Baillif S, Kodjikian L, Cohen SY. Impact of intravitreal aflibercept dosing regimens in treatment-naive patients with neovascular age-related macular degeneration: 2-year results of RAINBOW. BMC Ophthalmol. 2020 May 25;20(1):206. doi: 10.1186/s12886-020-01468-z.
- Derived from this study: PubMed 31179386Weber M, Velasque L, Coscas F, Faure C, Aubry I, Cohen SY; RAINBOW study investigators. Effectiveness and safety of intravitreal aflibercept in patients with wet age-related macular degeneration treated in routine clinical practices across France: 12-month outcomes of the RAINBOW study. BMJ Open Ophthalmol. 2019 Apr 9;4(1):e000109. doi: 10.1136/bmjophth-2017-000109. eCollection 2019.
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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 Macular Degeneration, run by Bayer at 1 site in France.
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 5 inclusion and 4 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 France. 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?
Change in the measurement of best-corrected visual acuity (BCVA) from baseline to 12 months. (time frame: Baseline to 12 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 NCT02279537, which also lists 4 linked publications.
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.