Um estudo para aprender sobre os níveis sanguíneos de aflibercept quando altas doses de aflibercept são injetadas em ambos os olhos de participantes com edema macular diabético ou degeneração macular relacionada à idade neovascular (DEUTERON)
Um estudo farmacocinético de fase 4 aberto, não randomizado, multicêntrico para avaliar a exposição sistêmica após administração intravítrea bilateral de aflibercepte em altas doses (8 mg) em adultos com edema macular diabético ou degeneração macular relacionada à idade neovascular
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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Bratislava, Eslováquia, 851 07
- Univerzitna nemocnica Bratislava, Nem. Sv. Cyrila a Metoda
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Žilina, Eslováquia, 012 07
- Fakultna nemocnica s poliklinikou Zilina
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Budapest, Hungria, 1133
- Budapest Retina Associates
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Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Kozpont
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Prague, Tcheca, 150 00
- Axon Clinical, s.r.o.
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Prague, Tcheca, 10034
- Fakultní nemocnice Královské Vinohrady - Urologická klinikay
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Men or women ≥18 years of age (or country's legal age of adulthood if the legal age is >18 years).
- Participants (treatment naïve or previously treated) requiring intravitreal anti-vascular endothelial growth factor (VEGF) treatment in both eyes in the opinion of the investigator.
- Participants with type 1 or type 2 diabetes mellitus and DME in both eyes with active central involvement (CI-DME) in at least one eye with central retinal thickness (CRT) ≥300 µm (or ≥320 µm on Spectralis) as determined by the investigator at the screening visit, OR diagnosis of nAMD in both eyes with active subfoveal choroidal neovascularization (CNV) in at least one eye with intraretinal fluid (IRF) and/or subretinal fluid (SRF) on OCT as determined by the investigator at the screening 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 the result of DME or nAMD.
- A female participant is eligible to participate if she is not pregnant or breastfeeding. Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention.
Exclusion Criteria:
- Evidence of macular edema due to any cause other than diabetes mellitus in patients with DME or neovascular age-related macular degeneration in patients with nAMD in either eye.
- Active proliferative diabetic retinopathy (DR) in either eye.
- Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in either eye 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 eye within 12 weeks (84 days) of the screening visit or with IVT 8 mg or HD aflibercept in 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 16 weeks (112 days) of the screening visit, or OZURDEX® implant within 180 days of the screening visit or ILUVIEN® or RETISERT® implant at any time
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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. |
8 mg, intravitreal injection
Outros nomes:
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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. |
8 mg, intravitreal injection
Outros nomes:
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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. |
8 mg, intravitreal injection
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Maximum Observed Concentration (Cmax) of Free Aflibercept
Prazo: From pre-dose through 28 days after the regimen-specific aflibercept administration used for Cmax determination
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Cmax was defined as the maximum observed plasma concentration of free aflibercept for each participant during the regimen-specific semi-dense pharmacokinetic sampling period. Concentrations were assessed at pre-dose and at Days 1, 3, 7, 14, and 28 after the relevant aflibercept administration. The relevant administration was the baseline bilateral administration for Regimen 1, the third same-day bilateral administration at Week 8 for Regimen 2, and the third administration to the second eye for Regimen 3, administered one week after the third administration to the first eye. For each regimen, the highest observed concentration across these sampling points was selected as the participant's Cmax. Participant-level Cmax values were summarized by treatment regimen. |
From pre-dose through 28 days after the regimen-specific aflibercept administration used for Cmax determination
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 22578
- 2024-511665-11-00 (Identificador de registro: CTIS(EU))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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