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
Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
At least 1 eye with CI-DME requiring treatment
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
Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator