Table 3.
Primary Endpoint: Proportion of Participants with ≥2-Step Improvement in ETDRS DRSS from Baseline at Week 36 Measured in the Study Eye
| Parameter | Placebo (n = 47) | Vicasinabin 30 mg (n = 48) | Vicasinabin 200 mg (n = 43) |
|---|---|---|---|
| Number of participants (n) | 38 | 42 | 35 |
| Proportion of participants, n (%) | 3 (7.9) | 4 (9.5) | 2 (5.7) |
| (95% CI) | (2.7, 20.8) | (3.8, 22.1) | (1.6, 18.6) |
| Stratified analysis (CMH) (vs. placebo) | |||
| Percentage differencea (95% CI)b | NA | 1.2 (−11.9, 14.2) | −2.9 (−15.2, 9.1) |
| P value | 0.8586 | 0.6388 | |
| Stratified analysis (CMH) (30 vs. 200 mg) | |||
| Percentage differencea (95% CI)b | NA | NA | 4.4 (−7.2, 15.9) |
| P value | 0.4608 | ||
CI = confidence interval; CMH = Cochran-Mantel-Haenszel test; DRSS = Diabetic Retinopathy Severity Scale.
a
Based on the CMH estimate of the common risk difference using Mantel-Haenszelstratum weights and the Sato variance estimator.
b
Wilson's method.