Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years

• Diagnosed with Type 1 or Type 2 diabetes or non-diabetic control patients

• Best corrected visual acuity 20/32 or better (Snellen) (≥74 ETDRS letters)

• Meets criteria for one of the defined observational groups below

• Able and willing to provide informed consent

Exclusion Criteria:

• Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina

• Previous treatment of any kind for diabetic retinopathy or DME

• Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)

• History of rhegmatogenous retinal detachment or macular hole

• History of vitrectomy

• Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months

• Requiring treatment for DR/DME in the next 6 months

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 04/27/2026. Questions regarding updates should be directed to the study team contact.