EyeTREAT_245569 version 1.0
Research type
Research Study
Full title
Innovative computational tools to improve drug treatment of neovascular age-related macular degeneration
IRAS ID
245569
Contact name
E.M. del Amo Paez
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
1 years, 2 months, 15 days
Research summary
Age-related macular degeneration(AMD) is expected to affect almost 25 million Europeans by 2040. The AMD treatment consists in regular injections of the anti-VEGF therapeutic drug (bevacizumab, aflibercept, ranibizumab) 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(PK=drug concentration)-pharmacodynamic (PD=drug effect) 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. The models generated will 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.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0620
Date of REC Opinion
1 Oct 2018
REC opinion
Favourable Opinion