Neovascular Age-related Macular DegenerationBELUGANCT04641234
A Study Reviewing Medical Records to Learn More About Treat-and-extend With Eylea in Patients With Neovascular Age-related Macular Degeneration (nAMD).
An observational study of Neovascular Age-related Macular Degeneration, run by Bayer at 1 site in Belgium.
Trial summary
In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- How many people
- 330 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2020to 9 Jun 2021
- 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 to be enrolled into the study must have been diagnosed with neovascular age-related macular degeneration (nAMD) and started anti-VEGF treatment with aflibercept.
Who may be able to join
- Adult (≥18 years) patients diagnosed with nAMD
- Anti-VEGF treatment-naïve
- Started Intravitreal (IVT) aflibercept treatment between 01 January 2016 and 30 November 2018
- Aflibercept treatment according to Treat-and-Extend (T\&E) immediately after the loading dose
- Availability of medical records of aflibercept treatment.
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice during the aflibercept treatment
- Patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.
In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision.
The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed.
Read more
The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old.
All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following:
- the number of aflibercept eye injections the patients received
- how long the patients could wait between treatments
- the change in the patients' vision
- how many patients stopped treatment and why.
- associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.
- Being tested
- Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
- Keywords
- Retinal disorders, aflibercept, treat-and-extend
- Medical subject headings
- Retinal Diseases
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
As prescribed by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye. 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.
Number of injections in the first 24 months of treatment
Measured: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Last injection interval in the 2nd year of treatment
Measured: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Secondary outcomes (12)
Number of aflibercept injections during the 1st, 3rd and 4th year of treatment
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Last injection interval in the 1st, 3rd and 4th year
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year
Definition of 'most stable injection interval according to the ophthalmologist
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of monitoring visits during each year of the study
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study
BCVA is assessed by ETDRS (Early Treatment Diabetic Retinopathy Study) or Snellen chart with conversion to ETDRS.
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
Retinal and lesion characteristics were evaluated using spectral domain optical coherence tomography (OCT).
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED)
IRF:Intra-Retinal Fluid/ SRF: Sub-Retinal Fluid / PED:Pigment Epithelial Detachment
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment after 24 months
Reasons : Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment within the first 24 months
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment during first 24 months
Reasons :Adverse event, lack of efficacy, remission and stop monitoring, remission and start monitor-and-extend, reimbursement issues, patients' decision, unknown
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment after 24 months
Measured: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start11 Dec 2020
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related 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
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641234
- Sponsor's protocol ID
- 21573
- Acronym
- BELUGA
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2020
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Retrospective Chart Review Evaluating Treat-and-extend With Eylea® in Treatment naïve Patients With Neovascular Age-related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT04641234
- Acronym / sponsor ID
- BELUGA / 21573
- Keywords
- Retinal disorders, aflibercept, treat-and-extend
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 23 Nov 2020 (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.
In people with neovascular age-related macular degeneration (nAMD), the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in a part of the eye called the macula. These blood vessels can damage the macula, causing dark spots and blurriness in central vision.
The study drug, aflibercept, works by reducing VEGF levels in the eye.It has already been approved for patients to receive as a treatment for nAMD in a fixed 8-weekly or treat-and-extend dosing regimen after having received 3 monthly doses at the start of treatment. In this study, the researchers want to learn more about how often patients received aflibercept and how their vision changed.
The study will include patients with nAMD who had not received treatment to reduce VEGF levels in the eye before. These patients will have started treatment with aflibercept between January 2016 and November 2018. The study will include about 330 men and women who are at least 18 years old.
All of the patients had received aflibercept eye injections based on their doctor's instructions. The researchers will use the patients' medical records from January 2016 to November 2020 to measure the following:
- the number of aflibercept eye injections the patients received
- how long the patients could wait between treatments
- the change in the patients' vision
- how many patients stopped treatment and why.
- associations between patient and disease characteristics at the start of treatment with the number of aflibercept injections and patient's vision during treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)Adult Belgian patients diagnosed with neovascular age-related macular degeneration (nAMD) with treatment-naïve study eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients to be enrolled into the study must have been diagnosed with neovascular age-related macular degeneration (nAMD) and started anti-VEGF treatment with aflibercept.
Key inclusion criteria (5 listed)
- Adult (≥18 years) patients diagnosed with nAMD
- Anti-VEGF treatment-naïve
- Started Intravitreal (IVT) aflibercept treatment between 01 January 2016 and 30 November 2018
- Aflibercept treatment according to Treat-and-Extend (T\&E) immediately after the loading dose
- Availability of medical records of aflibercept treatment.
Key exclusion criteria (2 listed)
- Participation in an investigational program with interventions outside of routine clinical practice during the aflibercept treatment
- Patients with eye diseases that required surgery during the first 24 months of aflibercept treatment, e.g. advanced glaucoma, visually significant cataracts.
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)As prescribed by the treating physician | Drug | Cohort 1 |
Primary outcome
Number of injections in the first 24 months of treatment
Time frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
Last injection interval in the 2nd year of treatment
Time frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)
12 secondary outcomes
Number of aflibercept injections during the 1st, 3rd and 4th year of treatment
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Last injection interval in the 1st, 3rd and 4th year
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Most stable interval between aflibercept injections in the 2nd, 3rd and 4th year
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of monitoring visits during each year of the study
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Change in best corrected visual acuity (BCVA) from baseline to 90 days and after each year in the study
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Central retinal thickness (in μm) measured by Optical coherence tomography (OCT)
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with presence of fluid or anatomical parameters (IRF/SRF/PED)
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients with absence of fluid or anatomical parameters (IRF/SRF/PED)
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment after 24 months
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment within the first 24 months
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Reason for discontinuation of aflibercept treatment during first 24 months
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
Number of patients discontinuing aflibercept treatment after 24 months
Time frame: Retrospective analysis from 01-Jan-2016 to 30-Nov-2020
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 Jun 2022.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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 Neovascular Age-related Macular Degeneration, run by Bayer at 1 site in Belgium.
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 2 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 Jun 2022. 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 Belgium. 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?
Number of injections in the first 24 months of treatment (time frame: Retrospective analysis in the first 24 months of treatment (1 January 2016 - 30 November 2020)). 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?
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 Jun 2022.