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.
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
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
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Treatment groupsSee each treatment group below.
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator