Table 1.
List of DRSS Endpoints
Endpoints | Definition of Endpoints Based on Change in DRSS Steps From Baseline | |
---|---|---|
Binary | % ≥3-step progression | Classify patients into those with ≥3-step progression or not |
% ≥2-step progression | Classify patients into those with ≥2-step progression or not | |
% ≥3-step improvement | Classify patients into those with ≥3-step improvement or not | |
% ≥2-step improvement | Classify patients into those with ≥2-step improvement or not | |
Ordinal | % ≥3-step progression, no change, ≥3-step improvement | Classify patients into those with ≥3-step progression or with ≥3-step improvement or neither |
% ≥2-step progression, no change, ≥2-step improvement | Classify patients into those with ≥2-step progression or with ≥2-step improvement or neither | |
Change in ETDRS severity steps | No further derivation of change in DRSS steps |
Abbreviations: DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early Treatment Diabetic Retinopathy Study.