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Clinical Trial Summary

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: - check patients' eye health using various eye examination techniques (slit lamp microscopy, OCT, and ophthalmoscopy) that may necessitate eye drops to widen the pupil) - measure patients' eye vision (BCVA) - do physical examinations - check vital signs - ask the participants questions about how they are feeling and what adverse events they are having. 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05473715
Study type Interventional
Source Bayer
Contact
Status Terminated
Phase Phase 4
Start date April 25, 2023
Completion date July 11, 2023

See also
  Status Clinical Trial Phase
Completed NCT04126317 - Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration Phase 2
Completed NCT06184360 - Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
Completed NCT04847895 - Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
Active, not recruiting NCT05439629 - Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Macular Degeneration Phase 3
Recruiting NCT05197270 - 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration Phase 1/Phase 2
Recruiting NCT06346600 - A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD