- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01988662
UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD) (UNRAVEL)
A 3 Months, patient-and Rater Blinded, Randomized, Prospective Study Comparing Systemic Anti-VEGF Effects Between Ranibizumab and Aflibercept in Treatment naïve Neovascular Age-related Macular Degeneration (nAMD) Patients
This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.
Free plasma VEGF-A level was measured in this study .
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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Singapore, Cingapura, 117549
- Novartis Investigative Site
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Singapore, Cingapura, 574623
- Novartis Investigative Site
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Makati City, Filipinas, 1209
- Novartis Investigative Site
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Pasig City, Filipinas, 1605
- Novartis Investigative Site
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Quezon City, Filipinas, 1102
- Novartis Investigative Site
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Be'er Sheva, Israel, 84101
- Novartis Investigative Site
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Haifa, Israel, 3525408
- Novartis Investigative Site
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Haifa, Israel, 3436212
- Novartis Investigative Site
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Kfar-Saba, Israel, 4428164
- Novartis Investigative Site
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Petach Tikva, Israel, 49100
- Novartis Investigative Site
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Rehovot, Israel, 7610001
- Novartis Investigative Site
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Tel Aviv, Israel, 6423906
- Novartis Investigative Site
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Kuala Lumpur, Malásia, 59200
- Novartis Investigative Site
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Selangor Darul Ehsan
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Petaling Jaya, Selangor Darul Ehsan, Malásia, 46200
- Novartis Investigative Site
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Daegu, Republica da Coréia, 705-703
- Novartis Investigative Site
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Seoul, Republica da Coréia, 150-950
- Novartis Investigative Site
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Seoul, Republica da Coréia, 06273
- Novartis Investigative Site
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Korea
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Seoul, Korea, Republica da Coréia, 05505
- Novartis Investigative Site
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Seoul, Korea, Republica da Coréia, 03722
- Novartis Investigative Site
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Bangkok, Tailândia, 10330
- Novartis Investigative Site
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Bangkok, Tailândia, 10400
- Novartis Investigative Site
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Bangkoknoi
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Bangkok, Bangkoknoi, Tailândia, 10700
- Novartis Investigative Site
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Lin-Kou, Taiwan, 33305
- Novartis Investigative Site
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Key Inclusion Criteria
- Newly diagnosed Age-related Macular Degeneration (AMD)
- No previous treatment received for diagnosed AMD
- Visual Acuity 6/7.5 to 6/96
Key Exclusion Criteria:
- standard exclusion criteria for anti-VEGF treatment
- Visual Acuity <6/96
- nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
- other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
- participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Ranibizumab
104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT.
0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician.
3 injections were performed (Baseline, Month 1, Month 2).
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Blood measurement
Outros nomes:
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Comparador Ativo: Aflibercept
101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT.
2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician.
3 injections were performed (Baseline, Month 1, Month 2).
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Blood measurement
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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Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent
Prazo: Change from baseline at Month 3
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Percent change in blood VEGF level is calculated as the difference in blood VEGF level measured after 3 month of anti-VEGF agent IVT treatment (Ranibizumab or Aflibercept) when compared to baseline blood VEGF level.
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Change from baseline at Month 3
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percent Change From Baseline in Plasma VEGF Level Overtime
Prazo: Change from baseline up to month 3
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Plasma VEGF measurement performed at all visits and compared to baseline level
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Change from baseline up to month 3
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Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime
Prazo: pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
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VEGF level and anti-VEGF concentration measured in the blood at each single visit, including pre- and post-dose measurement at the dosing visits.
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pre-dose to post-dose at Baseline, week 1, week 2, month 1, month 2, and month 3
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Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time
Prazo: Baseline, month 1, month 2, month 3
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BCVA score is assessed on study eye based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at a testing distance of 4 meters.
An increase in score indicates an improvement in acuity.
Change from baseline calculated as observed post-baseline value - baseline value.
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Baseline, month 1, month 2, month 3
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Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time
Prazo: Baseline, month 1, month 2, month 3
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CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area. Change from baseline calculated as observed post-baseline - baseline value. |
Baseline, month 1, month 2, month 3
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Number of Patients With Ocular and Systemic Adverse Events
Prazo: Day 1 to day 85
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The incidence of reported treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAE).
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Day 1 to day 85
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CRFB002A-MAX-IL-01
- 2013-003482-34 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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