Wet Macular DegenerationTITANNCT02321241
Real Life of Aflibercept in France in Patients Refractory to Ranibizumab: Observational Study in Wet AMD
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in France.
Trial summary
The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment. 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, BAY-86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 236 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2016to 18 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of wAMD refractory to ranibizumab (persistence of fluid) who started a treatment with Anti VEGF (Aflibercept) may be included in the study
Who may be able to join
- Man or woman > 18 years old
- Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)
- Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)
- Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015
- Written informed consent given
Who cannot join
- Patient who do not meet the local indication criteria for aflibercept treatment. Contraindications listed in the local SmPC (Summary of Product Characteristics) have to be considered
- Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)
- Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)
- Patient with a Visual Acuity (VA) <1/10
- Patient with Fibrosis involving Macula
- Patient with atrophic AMD
- Patient with any other retinal disease as myopia, diabetic retinopathy, diabetic macular oedema,chorioretinal anastomosis (CRA),, angioid streaks
- Patients 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 Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept
The aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.
The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab
Read the detailed description
The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.
The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (EYLEA, BAY-86-5321)
- Keywords
- Wet-AMD, Refractory patients to ranibizumab, Real life, Switch, 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, BAY-86-5321)Drug
- st year: 3 monthly injections followed by 1 injection every two months
- nd year and following: injection according the visual and anatomical results observed the 1st year
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection Receives: Drug: Aflibercept (EYLEA, BAY-86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm))
The 12 month follow up visit is the visit 12 month after the first injection of aflibercept
Measured: Between initial visit and 12 month follow up visit
Secondary outcomes (5)
Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters
The end of study visit is the visit 12 month after the first injection of aflibercept or after last follow up visit when the patient drop out the study whichever apply..
Measured: Between initial visit and up to 1 year maximum
Proportion of patients with less than 15 letters loss
Measured: Between initial visit and up to 1 year maximum
Proportion of patients with dry-OCT
Measured: Between initial visit and up to 1 year maximum
Mean duration of treatment with ranibizumab before initiation of aflibercept
Measured: Between initial visit and up to 1 year maximum
Mean change in Central retinal thickness in µm (OCT)
Measured: Between initial visit and up to 1 year maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study start1 Feb 2016
- Primary completion18 Jan 2017
- Study completion18 Aug 2017
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
- Other
- Enrolment
- 236 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
- NCT02321241
- Sponsor's protocol ID
- 17405
- Other IDs
- EY1413FR
- Acronym
- TITAN
- Status last verified
- Jun 2018
- First submitted
- 17 Dec 2014
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.
PubMed 33596867
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A retrospecTive and Prospective Non-Interventional Study to Assess the Clinical pracTice in Real Life for Patients With Wet AMD Refractory to raNibizumab and Switching to Aflibercept
- ClinicalTrials.gov ID
- NCT02321241
- Acronym / sponsor ID
- TITAN / 17405
- Conditions
- Wet Macular Degeneration
- Keywords
- Wet-AMD, Refractory patients to ranibizumab, Real life, Switch, Aflibercept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Aug 2017 (actual)
- First posted
- 22 Dec 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 aim of the TITAN study is to describe the clinical practices of a cohort of patients with wAMD refractory to ranibizumab (persistence of intra-retinal and/or subretinal fluid) who switch to aflibercept after less than 12 months of ranibizumab treatment.
The study will be conducted in real-life conditions and will allow describing conditions of use of aflibercept in patients refractory to ranibizumab
Detailed description
The study is both retrsopective and prospective to collect local real life data on patients under routine treatment.
The observation periods starts on January 2014. Patients who initiated a treatment by Aflibercept between the 1st of january 2014 and the 31 December 2015 will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Aflibercept (EYLEA, BAY-86-5321)According to the recommendations of the Summary of Products Characteristics (SmPC) Administration by intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of wAMD refractory to ranibizumab (persistence of fluid) who started a treatment with Anti VEGF (Aflibercept) may be included in the study
Key inclusion criteria (5 listed)
- Man or woman > 18 years old
- Patient with wAMD previously treated with ranibizumab (for less than 12 months before initiation of Aflibercept)
- Refractory to ranibizumab (defined by persistent fluid despite a treatment conducted according to the HAS French recommendations with at least 3 loading doses injections)
- Patient who switched to aflibercept (Eylea) between 1st of January 2014 and 30th June 2015
- Written informed consent given
Key exclusion criteria (8 listed)
- Patient who do not meet the local indication criteria for aflibercept treatment. Contraindications listed in the local SmPC (Summary of Product Characteristics) have to be considered
- Recurrent patients with wAMD previously treated with ranibizumab and switched to aflibercept because of a high recurrence rate (recurrent patients described by Yonegawa et al.in AJO (American Journal of Ophthalmology )2013= exudation suppressed but high rate of injections)
- Patient who have been previously treated by any macular laser Visudyne/PD (Photodynamic therapy)
- Patient with a Visual Acuity (VA) <1/10
- Patient with Fibrosis involving Macula
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, BAY-86-5321)1. st year: 3 monthly injections followed by 1 injection every two months 2. nd year and following: injection according the visual and anatomical results observed the 1st year | Drug | Group 1 |
Primary outcome
Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm))
Time frame: Between initial visit and 12 month follow up visit
The 12 month follow up visit is the visit 12 month after the first injection of aflibercept
5 secondary outcomes
Proportion of patients whose BCVA increases by ≥ 0 letter, ≥ 5 letters, ≥ 10 letters, ≥15 letters
Time frame: Between initial visit and up to 1 year maximum
Proportion of patients with less than 15 letters loss
Time frame: Between initial visit and up to 1 year maximum
Proportion of patients with dry-OCT
Time frame: Between initial visit and up to 1 year maximum
Mean duration of treatment with ranibizumab before initiation of aflibercept
Time frame: Between initial visit and up to 1 year maximum
Mean change in Central retinal thickness in µm (OCT)
Time frame: Between initial visit and up to 1 year maximum
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 2 Jul 2018.
- Derived from this study: PubMed 33596867Razavi S, Kodjikian L, Giocanti-Auregan A, Dufour I, Souied E. Efficacy and safety of intravitreal aflibercept in ranibizumab-refractory patients with neovascular age-related macular degeneration. BMC Ophthalmol. 2021 Feb 17;21(1):90. doi: 10.1186/s12886-021-01841-6.
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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 8 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 2 Jul 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 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?
Treatment success rate (defined as a gain of at least 1 letter in BCVA and/or a diminution of CRT (expressed in µm)) (time frame: Between initial visit and 12 month follow up visit). 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 NCT02321241, 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 2 Jul 2018.