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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Huntington Beach, California, Estados Unidos, 92647
- Reclutamiento
- Retina Consultants of Southern California
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Contacto:
- Hani Salehi-Had, MD
- Número de teléfono: 657-227-9496
- Correo electrónico: i.gomez@retinasocal.com
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Georgia
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Augusta, Georgia, Estados Unidos, 30909
- Reclutamiento
- Southeast Retina Center, P.C.
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Contacto:
- Dennis M Marcus, MD
- Número de teléfono: 709-650-0061
- Correo electrónico: amitchell@southeastretina.com
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Reclutamiento
- Boston Medical Center Corporation
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Contacto:
- Steven D Ness, MD
- Número de teléfono: 617-414-4020
- Correo electrónico: sreevardhan.alluri@bmc.org
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Reclutamiento
- Henry Ford Health System
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Contacto:
- Paul A Edwards, MD
- Número de teléfono: 313-874-9167
- Correo electrónico: mdakhil1@hfhs.org
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Reclutamiento
- Mayo Clinic
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Contacto:
- Andrew J. Barkmeier, MD
- Número de teléfono: 507-538-8119
- Correo electrónico: Taylor.Laura2@mayo.edu
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Pennsylvania
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Monroeville, Pennsylvania, Estados Unidos, 15146
- Reclutamiento
- Retina-Vitreous Consultants, Inc.
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Contacto:
- Shripaad Y Shukla, MD
- Número de teléfono: 412-683-5300
- Correo electrónico: merlottil@retinapittsburgh.com
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Sewickley, Pennsylvania, Estados Unidos, 15143
- Reclutamiento
- Pittsburgh Clinical Trial Consortium
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Contacto:
- Leanne T. Labriola, DO, MBA
- Número de teléfono: 412-301-5326
- Correo electrónico: franco@pghtrials.com
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Texas
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Beaumont, Texas, Estados Unidos, 77707
- Reclutamiento
- Retina Consultants of Texas
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Contacto:
- William Pearce, MD
- Número de teléfono: 9008335921
- Correo electrónico: alaida.jimenez@retinaconsultantstexas.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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).
Otros nombres:
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Comparador activo: 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).
Otros nombres:
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Comparador activo: 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).
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 1 year
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Measured by the MNREAD test |
Baseline to 1 year
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Change in visual field function
Periodo de tiempo: Baseline to 1 year
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Measured by Humphrey Visual Field testing |
Baseline to 1 year
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Change in diabetic retinopathy severity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to 1 year
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Measured by optical coherence tomography angiography (OCTA) |
Baseline to 1 year
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Protocol AS (1)
- UG1EY014231 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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