Wet Age-related Macular DegenerationXTENDNCT03939767
Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 17 sites in 17 countries.
Trial summary
In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Wet Age-related Macular Degeneration
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- How many people
- 1,563 participants
- Where
- 17 sitesin 17 countries
- Study dates
- 12 May 2019to 17 Oct 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 2.000 patients from sites in Asia-Pacific, Europe, Latin America and North America.
Who may be able to join
- A diagnosis of wAMD.
- Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
- Treatment-naïve in the study eye (no prior therapy for wAMD).
- Patient age ≥50 years of age.
- Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Who cannot join
- Participation in an investigational program with interventions outside of routine clinical practice.
- Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
- Planned treatment regimen outside of the local marketing authorization.
- Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
- Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
- Any other retinal disease which may interfere with the treatment of wAMD.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
About this study
Official title: Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)
In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.
- Conditions
- Wet Age-related Macular Degeneration
- Being tested
- Aflibercept (Eylea, BAY86-5321)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.
| Study group | Role | What they receive |
|---|---|---|
| wAMD patients | Patients with a diagnosis of wAMD and naïve to any treatment in the study eye will be enrolled after the decision by treating physician for IVT aflibercept therapy according to the local label. Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in BCVA (best corrected visual acuity)
In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T\&E (Treat and Extend Regimen)) by label regimen.
Measured: Baseline to 12 months
Secondary outcomes (7)
The change in BCVA
Measured: Baseline to 24 and 36 months
The change in BCVA by intended treatment regimen
Measured: Baseline to 12, 24 and 36 months
The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters.
Measured: Baseline at 12, 24 and 36 months
The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)
Measured: At 12, 24 and 36 months
The changes in central retinal thickness (CRT)
Measured: Baseline to 12, 24 and 36 months
The number of injections
Measured: Baseline to 12, 24 and 36 months
The distribution of the intervals between injections
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start12 May 2019
- Primary completion7 Jul 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Wet 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
- Prospective
- Enrolment
- 1,563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939767
- Sponsor's protocol ID
- 20359
- Acronym
- XTEND
- Status last verified
- Sep 2024
- First submitted
- 4 May 2019
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later 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.
Publications
Bailey C, Chandran M, Gale R, Narendran N, Talks J, McGoey H, Keshk Z, Morgan-Warren P, Allmeier H, Machewitz T, Patel PJ, Varma D. 2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort. Eye (Lond). 2025 Apr;39(6):1138-1145. doi: 10.1038/s41433-024-03550-y. Epub 2024 Dec 24.
PubMed 39719502Korobelnik JF, Chaudhary V, Mitchell P, Kang SW, Tadayoni R, Allmeier H, Lee J, Zhang X, Machewitz T, Bailey C. XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Mar;13(3):725-738. doi: 10.1007/s40123-023-00867-x. Epub 2024 Jan 10.
PubMed 38198053
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)
- ClinicalTrials.gov ID
- NCT03939767
- Acronym / sponsor ID
- XTEND / 20359
- Conditions
- Wet Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,563 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 May 2019 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 7 May 2019 (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 this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wAMD patients | – | Drug: Aflibercept (Eylea, BAY86-5321)Patients with a diagnosis of wAMD and naïve to any treatment in the study eye will be enrolled after the decision by treating physician for IVT aflibercept therapy according to the local label. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 2.000 patients from sites in Asia-Pacific, Europe, Latin America and North America.
Key inclusion criteria (5 listed)
- A diagnosis of wAMD.
- Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice.
- Treatment-naïve in the study eye (no prior therapy for wAMD).
- Patient age ≥50 years of age.
- Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws).
Key exclusion criteria (6 listed)
- Participation in an investigational program with interventions outside of routine clinical practice.
- Patients with contraindications to IVT aflibercept listed in the local marketing authorization.
- Planned treatment regimen outside of the local marketing authorization.
- Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
- Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye.
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)As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study. | Drug | wAMD patients |
Primary outcome
The change in BCVA (best corrected visual acuity)
Time frame: Baseline to 12 months
In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T\&E (Treat and Extend Regimen)) by label regimen.
7 secondary outcomes
The change in BCVA
Time frame: Baseline to 24 and 36 months
The change in BCVA by intended treatment regimen
Time frame: Baseline to 12, 24 and 36 months
The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline
Time frame: Baseline at 12, 24 and 36 months
The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better (approximately 73 ETDRS letters)
Time frame: At 12, 24 and 36 months
The changes in central retinal thickness (CRT)
Time frame: Baseline to 12, 24 and 36 months
The number of injections
Time frame: Baseline to 12, 24 and 36 months
The distribution of the intervals between injections
Time frame: Up to 36 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 20 Sep 2024.
- Derived from this study: PubMed 39719502Bailey C, Chandran M, Gale R, Narendran N, Talks J, McGoey H, Keshk Z, Morgan-Warren P, Allmeier H, Machewitz T, Patel PJ, Varma D. 2-year results from an observational study of proactive treatment regimens with intravitreal aflibercept 2 mg in patients with nAMD in clinical practice: XTEND study UK cohort. Eye (Lond). 2025 Apr;39(6):1138-1145. doi: 10.1038/s41433-024-03550-y. Epub 2024 Dec 24.
- Derived from this study: PubMed 38198053Korobelnik JF, Chaudhary V, Mitchell P, Kang SW, Tadayoni R, Allmeier H, Lee J, Zhang X, Machewitz T, Bailey C. XTEND: Two-Year Results from a Global Observational Study Investigating Proactive Dosing of Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2024 Mar;13(3):725-738. doi: 10.1007/s40123-023-00867-x. Epub 2024 Jan 10.
- Individual participant dataSharing planned: No. Availability of this study's data will later 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.
17 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Age-related Macular Degeneration, run by Bayer at 17 sites in 17 countries.
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 6 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Argentina, Australia, Belgium, Canada, China and 12 more countries. 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?
The change in BCVA (best corrected visual acuity) (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 NCT03939767, which also lists 2 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 20 Sep 2024.