stop_circleTerminated/Withdrawn

Neovascular (wet) age-related macular degeneration

A study to learn how well aflibercept injected into the eye works and how safe it is when given in customized treatment intervals in patients with an eye disease called neovascular age-related macular degeneration after start of treatment

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

50 - N/A

Trial summary

Enrollment Goal
3
Trial Dates
April 2023 - July 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Uniklinik Lübeck / CCIMLübeck, 23538, Germany
Withdrawn
Makula-Netzhaut-Zentrum OberkasselDüsseldorf, 40549, Germany
Withdrawn
Augenzentrum am St. Franziskus-HospitalMünster, 48145, Germany
Withdrawn
Uni Greifswald / AugenklinikGreifswald, 17475, Germany
Withdrawn
St. Gertrauden KH / AugenklinikBerlin, 10713, Germany
Withdrawn
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Withdrawn
Uniklinik Ulm / AugenklinikUlm, 89075, Germany
Completed
Bristol Eye HospitalBristol, BS12LX, United Kingdom
Withdrawn
York General HospitalYork, YO13 8HE, United Kingdom
Withdrawn
Royal Victoria InfirmaryNewcastle upon Tyne, NE1 4LP, United Kingdom
Withdrawn
Sunderland Eye InfirmarySunderland, SR29HP, United Kingdom
Withdrawn
CHU Dijon - Hopital General - OphtalmologieDijon, 21033, France
Withdrawn
Hôpital de la Croix RousseLYON CEDEX 04, 69317, France
Withdrawn
CHU Bordeaux - Hopital Pellegrin - OphtalmologieBordeaux, 33076, France
Withdrawn
Centre d'Ophtalmologie - Paradis-MonticelliMARSEILLE, 13008, France
Withdrawn
Centre Ophtalmologique Transparence - ToursTours, 37000, France
Withdrawn
Centre Hospitalier Intercommunal de Creteil - OphtalmologieCreteil, 94010, France
Withdrawn
Hospital Universitari Sagrat CorBarcelona, 8029, Spain
Withdrawn
Hospital Clínico Universitario Lozano BlesaZaragoza, 50009, Spain
Withdrawn
Hospital Universitario Virgen de la MacarenaSevilla, 41071, Spain
Withdrawn
St. Joseph's Healthcare - HamiltonHamilton, L8G 5E4, Canada
Withdrawn
Centre hospitalier Affilie universitaire de QuebecQuebec, G1S 4L8, Canada
Completed
GOGiunta ophtalmologieSherbrooke, J1J 2B8, Canada
Withdrawn
Sunnybrook Health Sciences Center OphthalmologyToronto, M4N 3M5, Canada
Withdrawn
St Joseph's Health Care London - Ivey Eye InstituteLondon, N6A 4V2, Canada
Completed
Retina Center of OttawaOttawa, K2B7E9, Canada

Primary Outcome

  • Change in best-corrected visual acuity (BCVA)
    BCVA is measured by the early treatment diabetic retinopathy study (ETDRS) letter score for the study eye
    date_rangeTime Frame:
    From baseline to Week 36

Secondary Outcome

  • Number of IVT aflibercept injections per patient
    date_rangeTime Frame:
    From baseline up to Week 52
  • Number of IVT aflibercept injections per patient
    date_rangeTime Frame:
    From baseline up to Week 36
  • Number of patients achieving pre-defined treatment intervals (≥4, ≥8, ≥10, ≥12¸ ≥14, and 16 weeks)
    date_rangeTime Frame:
    At Week 36 and Week 52
  • Change in best-corrected visual acuity (BCVA)
    BCVA is measured by the early treatment diabetic retinopathy study (ETDRS) letter score for the study eye
    date_rangeTime Frame:
    From baseline up to Week 52
  • Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
    date_rangeTime Frame:
    From baseline up to Week 36 and Week 52

Trial design

A Parallel-group Phase 4, Open-label, Two-arm Study to Assess the Safety and Efficacy of Intravitreal (IVT) Aflibercept with Proactive Customized Treatment Intervals in Patients ≥50 Years of Age with No Fluid Due to Choroidal Neovascularization (CNV) Lesions Secondary to Neovascular (wet) Age-related Macular Degeneration (nAMD) Following Treatment Initiation with Aflibercept
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2