MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration. (MIND-AMD)
Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Despite the available treatments, the visual outcome is highly heterogeneous. The scientific interest is growing regarding the assessment of neuroretinal changes in AMD. Although AMD is mainly considered an outer retinal disease, recent evidence suggests a major involvement of retinal glia and neurons, i.e. an involvement of the inner retina. This damage may remarkably affect the morphological and functional AMD outcome, subverting retinal signal transmission cascade and more clearly explaining the outcome of the disease. The main goal of this study is to perform a multidisciplinary, multicenter, both prospective and retrospective evaluation of neuroretinal degeneration in different AMD stages in preclinical and clinical models.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Alessandro Arrigo, MD, PhD
- Número de teléfono: +390226433580
- Correo electrónico: arrigo.alessandro@hsr.it
Copia de seguridad de contactos de estudio
- Nombre: Adelaide Pina, MsC
- Correo electrónico: pina.adelaide@hsr.it
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients affected by intermediate, wet and dry (geographic atrophy) age-related macular degeneration (AMD) and healthy age- and gender-matched controls
Descripción
Inclusion Criteria:
- Confirmed diagnosis of AMD
Exclusion Criteria:
- low BCVA (<20/100)
- other ocular diseases
- uncontrolled systemic diseases potentially affecting data interpretation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: CASE_CONTROL
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients affected by AMD (different stages)
Patients affected by intermediate, wet and dry atrophic AMD |
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Healthy controls
Healthy age- and gender-matched control |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neuroretinal degeneration quantitative metrics
Periodo de tiempo: From January 2027 to January 2030
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Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration |
From January 2027 to January 2030
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Imaging metrics of neuroretinal changes
Periodo de tiempo: From January 2027 to January 2030
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Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration |
From January 2027 to January 2030
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MicroRNA profiles associated with AMD stages
Periodo de tiempo: From January 2027 to January 2030
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MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration. |
From January 2027 to January 2030
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Alessandro Arrigo, MD, PhD, IRCCS San Raffaele Scientific Institute, Milan, Italy
Publicaciones y enlaces útiles
Publicaciones Generales
- Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
- Natoli R, Fernando N. MicroRNA as Therapeutics for Age-Related Macular Degeneration. Adv Exp Med Biol. 2018;1074:37-43. doi: 10.1007/978-3-319-75402-4_5.
- Nassisi M, Fan W, Shi Y, Lei J, Borrelli E, Ip M, Sadda SR. Quantity of Intraretinal Hyperreflective Foci in Patients With Intermediate Age-Related Macular Degeneration Correlates With 1-Year Progression. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3431-3439. doi: 10.1167/iovs.18-24143.
- Nassisi M, Lei J, Abdelfattah NS, Karamat A, Balasubramanian S, Fan W, Uji A, Marion KM, Baker K, Huang X, Morgenthien E, Sadda SR. OCT Risk Factors for Development of Late Age-Related Macular Degeneration in the Fellow Eyes of Patients Enrolled in the HARBOR Study. Ophthalmology. 2019 Dec;126(12):1667-1674. doi: 10.1016/j.ophtha.2019.05.016. Epub 2019 May 29.
- Nassisi M, Tepelus T, Corradetti G, Sadda SR. Relationship Between Choriocapillaris Flow and Scotopic Microperimetry in Early and Intermediate Age-related Macular Degeneration. Am J Ophthalmol. 2021 Feb;222:302-309. doi: 10.1016/j.ajo.2020.04.018. Epub 2020 Apr 28.
- Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative approaches in multimodal fundus imaging: State of the art and future perspectives. Prog Retin Eye Res. 2023 Jan;92:101111. doi: 10.1016/j.preteyeres.2022.101111. Epub 2022 Aug 4.
- Arrigo A, Aragona E, Bianco L, Antropoli A, Berni A, Saladino A, Cosi V, Bandello F, Battaglia Parodi M. The Localization of Intraretinal Cysts Has a Clinical Role on the 2-Year Outcome of Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1069-1079. doi: 10.1016/j.oret.2023.07.025. Epub 2023 Jul 30.
- Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative Multimodal Imaging Characterization of Intraretinal Cysts versus Degenerative Pseudocysts in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2024 Dec;8(12):1118-1126. doi: 10.1016/j.oret.2024.05.019. Epub 2024 Jun 6.
- Arrigo A, Saladino A, Aragona E, Barresi C, Mularoni C, Bandello F, Battaglia Parodi M. Clinical and Imaging Biomarkers Associated with Outer Retinal Atrophy Onset in Exudative Age-Related Macular Degeneration: A Real-Word Prospective Study. Ophthalmol Ther. 2024 May;13(5):1185-1196. doi: 10.1007/s40123-024-00903-4. Epub 2024 Mar 6.
- Arrigo A, Aragona E, Del Fabbro S, Balduzzi E, Parodi MB, Bandello F. Quantitative Optical Coherence Tomography Detection of New Neovascular Branches and Association With Exudation Recurrence in Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2024 Jun 3;65(6):30. doi: 10.1167/iovs.65.6.30.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MIND-AMD
- GR-2024-12379726 (Otro número de subvención/financiamiento: Ministero della Salute)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Scientific publications and international conferences.
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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