A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration

Last updated: March 23, 2025
Sponsor: Bayer
Overall Status: Active - Not Recruiting

Phase

4

Condition

Macular Edema

Macular Degeneration

Diabetic Macular Edema

Treatment

Aflibercept (BAY86-5321, Eylea)

Clinical Study ID

NCT06591598
22578
2024-511665-11-00
  • Ages > 18
  • All Genders

Study Summary

Researchers are looking for a better way to treat participants who have diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD).

DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. DME is a leading cause of vision loss in working age adults. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older.

The study treatment Aflibercept (also called BAY 86-5321) is a drug that blocks a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye.

The main purpose of this study is to to collect more information on the blood levels of aflibercept when 8 mg aflibercept is injected in both eyes of participants with DME or nAMD.

For this, the researchers will analyze Maximum observed concentration (Cmax): the highest amount of aflibercept in participants' blood will be measured after multiple doses of aflibercept during the study.

Participants will receive 8 mg aflibercept as injections into the vitreous cavity (jelly-like substance that fills the centre of the eye) of both eyes.

Participants will be divided into three groups and will receive initial and maintenance injections of 8 mg aflibercept in both eyes. Researchers will closely monitor the health of the participants during the study.

During the study, the doctors and their study team will:

  • take blood and urine samples

  • do physical examinations

  • examine heart health using electrocardiogram (ECG)

  • check vital signs such as blood pressure, heart rate, body temperature

  • 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, irrespective if they think it is related or not to the study treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men or women ≥18 years of age (or country's legal age of adulthood if the legal ageis >18 years).

  • Participants (treatment naïve or previously treated) requiring intravitrealanti-vascular endothelial growth factor (VEGF) treatment in both eyes in the opinionof the investigator.

  • Participants with type 1 or type 2 diabetes mellitus and DME in both eyes withactive central involvement (CI-DME) in at least one eye with central retinalthickness (CRT) ≥300 µm (or ≥320 µm on Spectralis) as determined by the investigatorat the screening visit, OR diagnosis of nAMD in both eyes with active subfovealchoroidal neovascularization (CNV) in at least one eye with intraretinal fluid (IRF)and/or subretinal fluid (SRF) on OCT as determined by the investigator at thescreening visit.

  • Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320)in eyes with active disease and decreased vision determined to be primarily theresult of DME or nAMD.

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding. Women of childbearing potential (WOCBP) or men who are sexuallyactive with partners of childbearing potential must agree to use highly effectivecontraception prior to the initial dose/start of the first treatment, during thestudy, and for at least 4 months after the last administration of studyintervention.

Exclusion

Exclusion Criteria:

  • Evidence of macular edema due to any cause other than diabetes mellitus in patientswith DME or neovascular age-related macular degeneration in patients with nAMD ineither eye.

  • Active proliferative diabetic retinopathy (DR) in either eye.

  • Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in eithereye with CI-DME or active nAMD within 12 weeks (84 days) of the screening visit.

  • Prior treatment with intravitreal (IVT) 2 mg aflibercept (EYLEA) in either eyewithin 12 weeks (84 days) of the screening visit or with IVT 8 mg or HD afliberceptin either eye within 24 weeks (168 days) of the screening visit.

  • Prior treatment with any other approved IVT agent with anti-VEGF effect (e.g.ranibizumab, bevacizumab, brolucizumab, faricimab, pegaptanib sodium or biosimilars)in either eye within 4 weeks (28 days) of the screening visit.

  • Prior treatment with any ocular gene or cell therapy treatment in either eye.

  • Previous use of intraocular or periocular corticosteroids in either eye within 16weeks (112 days) of the screening visit, or OZURDEX® implant within 180 days of thescreening visit or ILUVIEN® or RETISERT® implant at any time

Study Design

Total Participants: 51
Treatment Group(s): 1
Primary Treatment: Aflibercept (BAY86-5321, Eylea)
Phase: 4
Study Start date:
September 02, 2024
Estimated Completion Date:
October 29, 2025

Connect with a study center

  • FN Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Fakultní nemocnice Královské Vinohrady - Urologická klinikay

    Praha 10, 10034
    Czechia

    Site Not Available

  • AXON Clinical s.r.o.

    Praha 5, 150 00
    Czechia

    Active - Recruiting

  • Axon Clinical s.r.o

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Axon Clinical, s.r.o.

    Praha 5, 150 00
    Czechia

    Site Not Available

  • Bajcsy-Zsilinszky Hospital

    Budapest, 1106
    Hungary

    Site Not Available

  • Budapest Retina Associates

    Budapest, 1133
    Hungary

    Site Not Available

  • Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106
    Hungary

    Site Not Available

  • Semmelweis Egyetem

    Budapest, 1122
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai

    Debrecen, 4032
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032
    Hungary

    Site Not Available

  • University Hospital Bratislava

    Bratislava, 851 07
    Slovakia

    Site Not Available

  • Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda

    Bratislava, 851 07
    Slovakia

    Site Not Available

  • FN nemocnica poliklinikou

    Zilina, 012 07
    Slovakia

    Site Not Available

  • Fakultna nemocnica s poliklinikou Zilina

    Zilina, 012 07
    Slovakia

    Site Not Available

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