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

Prior treatment

• 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.
• Participants who have completed the PINNACLE study \>12 months prior to their enrolment on SUMMIT.

Other illness

• Co-existent ocular disease, which might affect visual function or retinal morphology.
• Established glaucoma in either study eye or fellow eye with evidence of visual field loss or retinal nerve fibre loss (ocular hypertension is not an exclusion criterion unless associated with visual field loss or retinal nerve fibre loss in either eye).
• Myopia \> minus 6 diopters or a history of myopia \> minus 6 diopters if patient has had cataract/refractive surgery.

Other

• Cataract sufficient to affect retinal imaging.
• OCT evidence of MNV (e.g sub-retinal scar tissue, sub-retinal fluid or intra-retinal fluid associated with a pigment epithelial detachment).

• 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• Have not been considered 'withdrawn' (either by 'opt-out', or any reason that would deem them ineligible, e.g. disease progression) from the PINNACLE study at any timepoint.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with both eyes (OU) on the PINNACLE study, will still be eligible to enrol under OD/OS only, should one eye have been withdrawn prior to completing PINNACLE, or considered no longer eligible during enrolment on SUMMIT.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).