A Phase 4 interventional study of Aflibercept(BAY86-5321, Eylea) in Neovascular (Wet) Age-related Macular Degeneration, sponsored by Bayer. Terminated at 3 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by Bayer · Phase 4, Interventional, and Treatment
Researchers are looking for a better way to treat people who have neovascular (wet) age-related macular degeneration (nAMD or wet AMD). In people with wet AMD, the body makes too much of a protein called vascular endothelial growth factor (VEGF). This causes too many blood vessels to grow in the area of sharpest vision in the eye, called macula. Fluid buildup due to leakage from these vessels can damage the macula, leading to vision problems such as blurring or a blind spot in the central (straight ahead) vision needed for reading or face recognition or car driving. Wet AMD is common in people aged 50 and older.
The study treatment intravitreal aflibercept (also called BAY865321) is injected into the eye. It works by blocking the VEGF protein and thus reduces blood vessel growth. It has already been approved for patients with wet AMD to be given as intravitreal injection monthly at start and then every 8 weeks or longer. Repeated injections of aflibercept prevent worsening of vision but place a burden on the patient.
Doctors try to increase the time between injections (treatment interval) in routine clinical practice based on individual patient needs. This is called treat and extend (T\&E). Treatment intervals are stepwise extended or shortened depending on how the treatment works. This is checked with optical coherence tomography (OCT), an imaging technique used to observe relevant changes in the eye.
The main purpose of this study is to learn how well aflibercept works if treatment intervals are extended faster (timepoint of extension is the same for both treatments arms), compared to standard T\&E regimen in people with wet AMD in a preselected patient population with no fluid after treatment initiation.
To answer this, researchers will assess changes in vision called best corrected visual acuity (BCVA) between study start and after 36 weeks. Changes will then be compared between participants whose treatment intervals were extended early and those on standard T\&E regimen.
All participants will receive 2 mg aflibercept as intravitreal injection for up to 52 weeks in intervals of every 4 to 16 weeks.
Each participant will be in the study for up to 56 weeks. During this time 4 visits to the study site are set for all participants. The other visits are set individually. A final phone call is planned 3 days after treatment at the end of study.
During the study, the doctors and their study team will:
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
In addition, participants in the fast extension arm will be provided with a home monitoring OCT device.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 3 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Exclusion Criteria:
Any ocular or systemic condition expected to interfere with study outcomes and procedures, including but not limited to:
After the initial study injection at baseline, participants will receive their next study injection at Week 16. Participants in this study arm will also be issued a home monitoring device, which will allow for regular OCT monitoring (at least 5 times a week) at home.
Drug: Aflibercept(BAY86-5321, Eylea)
Participants will receive treatment in intervals maintained (8 weeks) or adjusted in 2 weeks increments each time (up to a maximum of 16 weeks and minimum of 4 weeks), as long as all extension/shortening criteria are met.
Drug: Aflibercept(BAY86-5321, Eylea)
2mg, intravitreal (IVT) injection
Change in Best-corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letters)
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
Time frame: Approximately 11 weeks
Number of Intravitreal (IVT) Aflibercept Injections
Participant took aflibercept on study eye.
Time frame: Approximately 11 weeks
Number of Patients Achieving Pre-defined Treatment Intervals
Pre-defined treatment intervals are: ≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks.
Time frame: Approximately 11 weeks
Change in BCVA (ETDRS Letters)
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
Time frame: Approximately 11 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
AEs that occurred or worsened after the first injection of study drug and no later than 30 days after the last injection of study drug was considered as treatment-emergent adverse events (TEAEs).
Time frame: Approximately 11 weeks
Study enrolled participants in 2 countries, between 25 Apr 2023 (first participant first visit) and 11 Jul 2023 (termination date).
| Milestone | Customized Treatment Interval | Standard T&E |
|---|---|---|
| Started | 2 | 1 |
| Completed | 0 | 0 |
| Not completed | 2 | 1 |
| Withdrew: Trial terminate | 2 | 1 |
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
No measurements were reported for this outcome.
Participant took aflibercept on study eye.
| Participants | Customized Treatment Interval | Standard T&E |
|---|---|---|
| 0 aflibercept injection | 1 | 0 |
| 1 aflibercept injection | 1 | 1 |
Pre-defined treatment intervals are: ≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks.
| Participants | Customized Treatment Interval | Standard T&E |
|---|---|---|
| Number of Patients Achieving Pre-defined Treatment Intervals | NA | NA |
Visual function was assessed using the ETDRS protocol (Early Treatment Diabetic Retinopathy Study Research Group. 1985). Visual acuity examiners must be certified to ensure consistent measurement of BCVA.
No measurements were reported for this outcome.
AEs that occurred or worsened after the first injection of study drug and no later than 30 days after the last injection of study drug was considered as treatment-emergent adverse events (TEAEs).
| Participants | Customized Treatment Interval | Standard T&E |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | 0 | 0 |
Collected over After the first injection of study drug and no later than 30 days after the last injection of study drug, up to 78 days. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study before the last contact, up to 78 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Customized Treatment Interval | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Standard T&E | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Customized Treatment Interval | Standard T&E | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 2 | 1 | 3 |
| Sex: Female, Male(Participants) | Customized Treatment Interval | Standard T&E | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Customized Treatment Interval | Standard T&E | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.vivli.org 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 member section of the portal.
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