Longitudinal Natural History Study of Retinal Function in Eyes of Patients With Diabetes

A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.

Key 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 Key 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