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

Sponsor
Bayer
Study ID
NCT06591598
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 2, 2024
Status verified
Oct 2025
Primary completion
Oct 14, 2025
Completion
Oct 14, 2025

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Regimen 1
    15 participants will be assigned to Regimen 1. Regimen 1 participants will be administered 8 mg aflibercept injections according to the Regimen 1 dosing schedule.
  • Experimental: Regimen 2
    Up to 15 participants will be assigned to Regimen 2. Regimen 2 participants will be administered 8 mg aflibercept injections according to the Regimen 2 dosing schedule.
  • Experimental: Regimen 3
    Up to 15 participants will be assigned to Regimen 3. Regimen 3 participants will be administered 8 mg aflibercept injections according to the Regimen 3 dosing schedule.

Primary Outcome Measure

Maximum observed concentration (Cmax) of free aflibercept [ Time Frame: Up to 52 weeks ]

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