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

NCT06682455 | Enrolling By Invitation DMC

• 2 other identifiers: 25693147270
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Sensitivity / specificity of OCT biomarkers

  Sensitivity / specificity of OCT biomarkers identified in the retrospective branch of our study at predicting disease progression towards advanced AMD i.e. development of early onset neurosensory atrophy or choroidal neovascularisation.

  2 years

Secondary Outcomes (1)

• Sensitivity / specificity of novel imaging characteristics

  2 years

Study Arms (1)

Patients with diagnosed intermediate age-related macular degeneration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have completed the PINNACLE study (Part 1) and have; 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).

You may qualify if:

• Have taken part in the PINNACLE study and progressed to/completed the final M36/V10 study visit.
• Have not been considered 'withdrawn' (either by 'opt-out', or any reason that would deem them ineligible, e.g. disease progression) from the PINNACLE study at any timepoint.
• Have a period of no longer than 12 months between their final M36/V10 PINNACLE study visit and the first SUMMIT study visit (if M36/V10 was missed, the participant will still be eligible if M32/V9 completion date is within 12 months of enrolment).
• Continued diagnosis of intermediate AMD (as defined by Ferris et al PMID: 23332590) in both eyes (i.e. large drusen \> 125 µm and/or any definite hyper- or hypopigmentary abnormalities associated with medium or large drusen), or intermediate AMD as defined above in one eye (study eye) and advanced AMD (GA or MNV secondary to AMD) in the other eye.
• Participants enrolled with both eyes (OU) on the PINNACLE study, will still be eligible to enrol under OD/OS only, should one eye have been withdrawn prior to completing PINNACLE, or considered no longer eligible during enrolment on SUMMIT.
• Have media clarity and pupillary dilation for adequate imaging and functional tests.
• Deemed able to meet the physical demands of attending 4-monthly appointments and undergo the examinations as listed in section 7.3, for the study duration (maximum 2 years).

You may not qualify if:

• Co-existent ocular disease, which might affect visual function or retinal morphology.
• Cataract sufficient to affect retinal imaging.
• Myopia \> minus 6 diopters or a history of myopia \> minus 6 diopters if patient has had cataract/refractive surgery.
• Major ocular surgery (e.g. corneal transplant, vitreo-retinal surgery) 3 months prior or anticipated within the next 6 months following enrolment (not including cataract surgery).
• Taking drugs known to cause retinal toxicity, such as hydroxychloroquine or tamoxifen.
• OCT evidence of MNV (e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment).
• Participants who have completed the PINNACLE study \>12 months prior to their enrolment on SUMMIT.

Sponsors & Collaborators

• University of Southampton: lead
• King's College London: collaborator
• Imperial College London: collaborator
• Medical University of Vienna: collaborator
• University of Michigan: collaborator
• University College, London: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (8)

Medical University of Vienna

Vienna, 1090, Austria

Location

The Princess Alexandra Hospital Nhs Foundation Trust

Harlow, Essex, CM20 1QX, United Kingdom

Location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

St Mary's Hospital

Newport, Isle Of Wight, PO30 5TG, United Kingdom

Location

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Frimley Health Nhs Foundation Trust

Frimley, Surrey, GU16 7UJ, United Kingdom

Location

Salisbury Nhs Foundation Trust

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: June 12, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Currently available and can be accessed indefinitely.
• Access Criteria: Requests for further information such as a clinical study report will be considered by the investigators following the end of the study and publication of primary outputs.

Locations

GB (7); AU (1)