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
Single group
Anti-Vascular Endothelial Growth Factor
DrugAll study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Change in multifocal pupillographic objective perimetry (mfPOP) response delays
mfPOP response delays measured using the Objective Field Analyzer (OFA)
Change in area under the log contrast sensitivity function (AULCSF)
AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system
Change in electroretinography parameter
Measured by the RETeval device
Change in reading performance
Measured by the MNREAD test
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Jaeb Center for Health Research
Lead sponsor
National Eye Institute (NEI)
Collaborator
