Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - SUMMIT (Part 2)

Overview

We will conduct a prospective, non-interventional roll-over extension of the PINNACLE study (Deciphering AMD by deep phenotyping and machine learning). This will include up to 300 intermediate AMD participants (= approximately 450 untreated intermediate AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)). As per the PINNACLE study, SUMMIT study participants will continue to be followed using OCT imaging every 4 months for a further 2-years, to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. Across both studies combined, we will be able to detect the earliest focal sites of disease progression over a total 5-year follow-up.

Participants who have taken part in the PINNACLE study and have progressed to the final visit (i.e. have not made the decision to withdraw or met any withdrawal criteria prior to completing month 36/visit 10), within 12 months of enrolment to SUMMIT will be considered for this cohort. We will recruit patients with a continued diagnosis of 1) intermediate AMD in the study eye and advanced AMD in the non-study eye or 2) patients with bilateral intermediate AMD (where both eyes will be included). As within PINNACLE, there will be four clinical sites performing detailed assessments on their recruited patients, and an additional eight referral sites in the United Kingdom who will follow patients by Spectral Domain Optical Coherence Tomography (SD-OCT) every 4 months. The acquired images from all sites will be sent to the Vienna Reading Centre for review. After consent, study assessments including both structural and functional visual testing and imaging procedures, and the collection of medical and medication data will be performed at 4-monthly intervals across a maximum 2-year period. Participants will attend a maximum of 6 visits, 2 of which (M48 and M60), will be classified as 'annual' visits, where enhanced imaging and testing will take place to further identify and assess focal and global changes. Demographic data collected as part of the PINNACLE study baseline procedures, including birth year, smoking history and body mass index data will not be re-collected as part of the SUMMIT study. The information previously collected will however be included within the SUMMIT analysis, as has also been considered previously. The data extracted from the genotyping samples within the PINNACLE study will also be included in the SUMMIT final analysis, but no additional samples or research on existing samples will be performed under the SUMMIT study protocol.