Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents (AS)
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
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California
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Huntington Beach, California, Estados Unidos, 92647
- Recrutamento
- Retina Consultants of Southern California
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Contato:
- Hani Salehi-Had, MD
- Número de telefone: 657-227-9496
- E-mail: i.gomez@retinasocal.com
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Georgia
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Augusta, Georgia, Estados Unidos, 30909
- Recrutamento
- Southeast Retina Center, P.C.
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Contato:
- Dennis M Marcus, MD
- Número de telefone: 709-650-0061
- E-mail: amitchell@southeastretina.com
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Recrutamento
- Boston Medical Center Corporation
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Contato:
- Steven D Ness, MD
- Número de telefone: 617-414-4020
- E-mail: sreevardhan.alluri@bmc.org
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Recrutamento
- Henry Ford Health System
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Contato:
- Paul A Edwards, MD
- Número de telefone: 313-874-9167
- E-mail: mdakhil1@hfhs.org
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Recrutamento
- Mayo Clinic
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Contato:
- Andrew J. Barkmeier, MD
- Número de telefone: 507-538-8119
- E-mail: Taylor.Laura2@mayo.edu
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Pennsylvania
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Monroeville, Pennsylvania, Estados Unidos, 15146
- Recrutamento
- Retina-Vitreous Consultants, Inc.
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Contato:
- Shripaad Y Shukla, MD
- Número de telefone: 412-683-5300
- E-mail: merlottil@retinapittsburgh.com
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Sewickley, Pennsylvania, Estados Unidos, 15143
- Recrutamento
- Pittsburgh Clinical Trial Consortium
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Contato:
- Leanne T. Labriola, DO, MBA
- Número de telefone: 412-301-5326
- E-mail: franco@pghtrials.com
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Texas
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Beaumont, Texas, Estados Unidos, 77707
- Recrutamento
- Retina Consultants of Texas
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Contato:
- William Pearce, MD
- Número de telefone: 9008335921
- E-mail: alaida.jimenez@retinaconsultantstexas.com
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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:
- Age ≥18 years
- Diagnosed with Type 1 or Type 2 diabetes
- Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
- At least 1 eye with CI-DME requiring treatment
- Able and willing to provide informed consent.
Key exclusion criteria:
- Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
- Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Mild center-involved diabetic macular edema
Eyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Outros nomes:
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Comparador Ativo: Moderate Center-involved diabetic macular edema
Eyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Outros nomes:
|
|
Comparador Ativo: Severe Center-involved diabetic macular edema
Severe CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Prazo: Baseline to 1 year
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mfPOP response delays measured using the Objective Field Analyzer (OFA) |
Baseline to 1 year
|
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Change in area under the log contrast sensitivity function (AULCSF)
Prazo: Baseline to 1 year
|
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system |
Baseline to 1 year
|
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Change in electroretinography parameter
Prazo: Baseline to 1 year
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Measured by the RETeval device |
Baseline to 1 year
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Change in reading performance
Prazo: Baseline to 1 year
|
Measured by the MNREAD test |
Baseline to 1 year
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|
Change in visual field function
Prazo: Baseline to 1 year
|
Measured by Humphrey Visual Field testing |
Baseline to 1 year
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Change in diabetic retinopathy severity
Prazo: Baseline to 1 year
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Assessed by ultra-widefield (UWF) color fundus photography |
Baseline to 1 year
|
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Change in retinal vascular pathology
Prazo: Baseline to 1 year
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Assessed by ultra-widefield fluorescein angiography (UWF-FA) |
Baseline to 1 year
|
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Change in retinal structure
Prazo: Baseline to 1 year
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measured by optical coherence tomography (OCT) |
Baseline to 1 year
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Change in retinal microvascular parameter
Prazo: Baseline to 1 year
|
Measured by optical coherence tomography angiography (OCTA) |
Baseline to 1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
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
Outros números de identificação do estudo
- Protocol AS (1)
- UG1EY014231 (Concessão/Contrato do NIH dos EUA)
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