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

Sponsor
University of Southampton
Study ID
NCT06682455
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Nov 12, 2024
Start date
Jun 12, 2024
Status verified
Nov 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Patients with diagnosed intermediate age-related macular degeneration

Primary Outcome Measure

Sensitivity / specificity of OCT biomarkers [ Time Frame: 2 years ]

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