do_not_disturb_altRecruitment Complete

Diabetic macular edema, Neovascular age-related macular degeneration

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

Trial purpose

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 Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
51
Trial Dates
September 2024 - October 2025
Phase
Phase 4
Could I Receive a placebo
No
Products
Aflibercept (BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Axon Clinical, s.r.o.Praha 5, 150 00, Czech Republic
Active, not recruiting
Fakultní nemocnice Královské Vinohrady - Urologická klinikayPraha 10, 10034, Czech Republic
Active, not recruiting
Debreceni Egyetem Klinikai KozpontDebrecen, 4032, Hungary
Active, not recruiting
Budapest Retina AssociatesBudapest, 1133, Hungary
Active, not recruiting
Fakultna nemocnica s poliklinikou ZilinaZilina, 012 07, Slovakia
Suspended
Semmelweis EgyetemBudapest, 1122, Hungary
Suspended
Budapesti Bajcsy-Zsilinszky Korhaz es RendelointezetBudapest, 1106, Hungary
Active, not recruiting
Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a MetodaBratislava, 851 07, Slovakia

Primary Outcome

  • Maximum observed concentration (Cmax) of free aflibercept
    date_rangeTime Frame:
    Up to 52 weeks

Trial design

An open-label, non-randomized, multi-center, phase 4 pharmacokinetic study to evaluate the systemic exposure after bilateral intravitreal administration of high dose (8 mg) aflibercept in adults with diabetic macular edema or neovascular age-related macular degeneration
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Non-randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
3