Innovative tool for personalized treatment of patients with neovascular age-macular degeneration: dosage optimization for long term efficacy treatment

Project Information

EyeTREAT

Grant agreement ID: 799880

DOI

10.3030/799880

Project closed

EC signature date 7 March 2018

Start date 1 September 2018

End date 30 November 2019

Funded under

• EXCELLENT SCIENCE - Marie Skłodowska-Curie Actions

Total cost

€ 122 159,25

EU contribution

€ 122 159,25

Coordinated by

THE UNIVERSITY OF MANCHESTER
United Kingdom

Periodic Reporting for period 1 - EyeTREAT (Innovative tool for personalized treatment of patients with neovascular age-macular degeneration: dosage optimization for long term efficacy treatment)

Reporting period: 2018-09-01 to 2019-11-30

Summary of the context and overall objectives of the project

The visual threatening illnesses are increasing with the ageing population, such as age-related macular degeneration (AMD) that is expected to affect almost 25 million Europeans by 2040. The AMD treatment consists in regular injections of the anti-VEGF therapeutic drug (Lucentis, Avastin, Eylea) into the eye ball, vitreous, for the rest of the patient life. However, the dosing intervals varies widely among the patients and there is no a clear consensus or quantitative method for evaluating the injection frequency. For that, computational tools linking the drug dose regimen and the drug effect in the retina are needed.
However, such pharmacokinetic-pharmacodynamic models are still missing. Combining population pharmacokinetic and optical coherence tomography (OCT) imaging technique is a new, novel and promising approach. The drug effect can be evaluated non-invasively, measuring the central macular thickness in the retina scan. In the present 15 month-project, preliminary models that link drug concentration in vitreous and effect on the decrease of the thickness on the central retina have been generated. The final models can allow
appropriate individualized dosing regimen to the patients in clinics that will be anticipated from individual retina scan determinations with OCT.
The optimization and personalization of dosing regimen will ensure an efficient long-lasting treatment, improving patient quality of life while reducing the burden to the health care system. Moreover, the models will increase our understanding in the treatments, constitute a pioneer tool in effect assessment in ocular therapeutic field and a first step towards more advanced ophthalmic models.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The beneficiary has reached the specific training objectives on learning population PKPD modeling (non-linear mixed effects method) at Centre for Applied PK research in the University of Manchester; on learning transferable skills on leadership and management and pedagogy (awarded with level 5 award in Leadership and Management issued by The City and Guilds of London Institute and with the certificate of the status of Fellow of the Higher Education Academy). Morever, I have get experience in mentoring/supervision PhD student, working in a drug modelling company, being engaged with social responsibilities activities and expanding my network in the host entity and in conferences and workshops.
I have attended seven international and national conferences and meetings disseminating my research with oral presentation or poster. I have published four scientist articles, having one ready for submission related to new antiangiogenic drug. The results on the present clinical project related to Avastin drug (bevacizumab) is under elaboration.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The methods, tools and approaches that are developed in this project are cutting-edge in the area of ophthalmology, with innovative potential towards a more efficient treatment of the patients. Successful models can be implemented in a computer user friendly application that ophthalmologist can use to take decisions in optimal dosing regimen for the treatment of AMD patients.

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