Wet Macular DegenerationINSIGHTNCT03278262
The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting
An observational study of Wet Macular Degeneration, run by Bayer at 1 site in Sweden.
Trial summary
The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting. In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who… 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, BAY86-5321)
- How many people
- 2,312 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2017to 31 Dec 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: All patients registered in the Swedish Macula Register during the study period.
Who may be able to join
- Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.
Who cannot join
- Eyes treated previously with another anti-VEGF drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer
The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.
In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.
- Conditions
- Wet Macular Degeneration
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- 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, BAY86-5321)Drug
Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.
| Study group | Role | What they receive |
|---|---|---|
| >= 70 letters | Baseline VA >= 70 letters Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| 36-69 letters | Baseline VA 36-69 letters Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| <=35 letters | Baseline VA <=35 letters Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity (VA) (Snellen)
Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.
Measured: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.
Measured: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in Lasbarhetsindex (LIX, Readability Index)
Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden
Measured: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Secondary outcomes (4)
Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points
Patients with Gain of vision 5-15 letters, > 15 letters; Loss of vision >5-<15 letters; >15 letters or Stable -5-+5 letters at the annual time points
Measured: At year 1 and year 2
Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
In all patients and stratified by baseline VA (groups 1-3)
Measured: Up to 2 years
Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
In all patients and stratified by baseline VA (groups 1-3)
Measured: Up to 2 years
Proportion of patients with no need of Vision Aid support
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start1 Sep 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 2,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278262
- Sponsor's protocol ID
- 19473
- Acronym
- INSIGHT
- Status last verified
- Oct 2018
- First submitted
- 28 Aug 2017
- Last updated
- 29 Oct 2018
- 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 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INSIGHT - The Impact of baseliNe viSual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical settinG. Analysis of Data From the SwedisH Macula RegisTer
- ClinicalTrials.gov ID
- NCT03278262
- Acronym / sponsor ID
- INSIGHT / 19473
- Conditions
- Wet Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,312 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Sep 2017 (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 study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.
In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| >= 70 letters | – | Drug: Aflibercept (Eylea, BAY86-5321)Baseline VA >= 70 letters |
| 36-69 letters | – | Drug: Aflibercept (Eylea, BAY86-5321)Baseline VA 36-69 letters |
| <=35 letters | – | Drug: Aflibercept (Eylea, BAY86-5321)Baseline VA <=35 letters |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients registered in the Swedish Macula Register during the study period.
Key inclusion criteria (1 listed)
- Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.
Key exclusion criteria (1 listed)
- Eyes treated previously with another anti-VEGF drug.
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, BAY86-5321)Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient. | Drug | 36-69 letters, <=35 letters, >= 70 letters |
Primary outcome
Change in Visual Acuity (VA) (Snellen)
Time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in VA (Snellen) at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up in all eyes and stratified in the three groups by Visual Acuity (VA) at baseline.
Change in Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change Early Treatment Diabetic Retinopathy Study (ETDRS) in all eyes and stratified in the three groups by VA at baseline.
Change in Lasbarhetsindex (LIX, Readability Index)
Time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up
Change in LIX in all eyes and stratified in the three groups by VA at baseline. LIX: Jaeger/LIX adult A chart (Ortho-KM, Lund, Sweden). The LIX-chart is a standardized readability index for measuring near vision and it is used almost ubiquitously in eye clinics in Sweden
4 secondary outcomes
Proportion of patients with Gain of vision 5 to 15 letters; > 15 letters; Loss of vision >5 to <15 letters; >15 letters or Stable -5 to +5 letters at the annual time points
Time frame: At year 1 and year 2
Proportion of patients that recuperate 20/20 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
Time frame: Up to 2 years
Proportion of patients that recuperate 20/40 vision (driving vision) in all patients and stratified by baseline VA (groups 1-3)
Time frame: Up to 2 years
Proportion of patients with no need of Vision Aid support
Time frame: Up to 2 years
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 Oct 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.
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 Wet Macular Degeneration, run by Bayer at 1 site in Sweden.
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 1 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 Oct 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 Sweden. 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 Visual Acuity (VA) (Snellen) (time frame: at 3±1 months, 6±1months, 12±2 months and at 24±2 months follow-up). 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 Oct 2018.