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MACUSTAR

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Develop and validate appropriate and acceptable outcome measures in intermediate...

Develop and validate appropriate and acceptable outcome measures in intermediate age related macular degeneration for future interventional clinical trials Sofia ref. 116076 Despite significant advances in the treatment and understanding of late stage age-related macular degeneration (AMD), it continues to be the main cause of irreversible severe visual loss in Europe and its prevalence and incidence... ver más

31/05/2024

UKB

16M€

Presupuesto del proyecto: 16M€

Líder del proyecto

UNIVERSITATSKLINIKUM BONN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 19 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2024-05-31

IMI2-2015-07-04: DRY AGE-RELATED MACULAR DEGENERATIO... Specific Challenge:Age-related macular degeneration (AMD) is a chronic disease and among the leading...

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

19 Participantes

UKB

3.80M€ | Lider

VIDRIERÍA Y CRISTALERÍA DE L...

641.96K€ | Participante

UNIVERSITY COLLEGE LONDON

844.63K€ | Participante

NETWORK OF COORDINATING CENT...

N.D. | Participante

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Duración del proyecto: 80 meses Fecha Inicio: 2017-09-12
Fecha Fin: 2024-05-31

Líder del proyecto

UNIVERSITATSKLINIKUM BONN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 16M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Despite significant advances in the treatment and understanding of late stage age-related macular degeneration (AMD), it continues to be the main cause of irreversible severe visual loss in Europe and its prevalence and incidence will increase with current demographic trends. In order to reduce the significant burden of late stage AMD, novel interventions should aim at stopping or delaying progression from the preceding disease stage intermediate AMD (iAMD) to late stage AMD. As a prerequisite, validated clinical endpoints for iAMD are needed. These should be acceptable to regulatory agencies, health technology assessment (HTA) bodies, and payers. Currently such endpoints do not exist for iAMD clinical trials (CTs). In addition, there is good evidence indicating that patients with iAMD experience some impairment of visual function yet it is unknown to what extend this impacts the patients’ life nor can it be reliably measured and quantified. It is also unknown whether there are specific risk factors in the population of iAMD patients which identify those with more rapid progression to late stages of the disease. Therefore, to enable successful development of iAMD interventions validated functional, morphological and patient--reported endpoints for CTs, which are clinically meaningful and accepted by regulatory agencies, are required. In addition, functional decline in iAMD, as well as, specific risk factors for iAMD progression to late stage AMD need to be better characterized to inform and improve conduct of future iAMD CTs. Against this background, the major objective of MACUSTAR is to develop novel clinical endpoints for CTs with a regulatory and patient access intention in patients with iAMD. Additional objectives are to characterize visual impairment in iAMD and its progression, as well as, identify risk factors for progression. For clinical endpoint development, functional, structural and patient-reported outcome measures will be assessed with regards to

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