Table 3.
Mean and median changes in ophthalmologic assessments in the emixustat and placebo groups, in the study eye
| Measurement | Mean baseline value (SD) | Mean day 85 value (SD) | Mean change (SD) | Median change (Q1, Q3) | Mean baseline value (SD) | Mean day 85 value (SD) | Mean change (SD) | Median change (Q1, Q3) | P value Difference in mean changes between groups |
|---|---|---|---|---|---|---|---|---|---|
| All subjects | Emixustat group (N = 9) | Placebo group (N = 11) | |||||||
| CST (μm) | 334.2 (134.1) | 322.3 (140.2) | − 11.9 (36.5) | − 6.0 (− 15, + 2) | 297.2 (46.3) | 333.4 (103.9) | + 36.2 (69.0) | + 9.0 (+ 1, + 38) | 0.076* |
| TMV (mm3) | 9.90 (1.71) | 9.78 (1.71) | − 0.13 (0.19) | − 0.08 (− 0.20, − 0.01) | 9.39 (1.27) | 9.63 (1.56) | + 0.23 (0.41) | + 0.07 (− 0.03, + 0.46) | 0.026* |
| Area of retinal neovascularization (mm2)a | 5.52 (7.89) | 5.98 (9.91) | + 0.46 (3.11) | + 0.70 (− 1.55, + 1.79) | 1.91 (2.29) | 3.07 (3.82) | + 1.16 (2.10) | + 0.06 (0.00, + 1.86) | 0.60 |
| BCVA (letters) | 75.2 (6.0) | 74.1 (8.2) | − 1.1 (8.9) | + 2.0 (− 5, + 4) | 79.2 (10.4) | 78.8 (10.1) | − 0.4 (4.1) | 0 (− 2, + 3) | 0.80 |
| Subjects with DME | Emixustat group (N = 5) | Placebo group (N = 7) | |||||||
| CST (μm) | 388.6 (164.6) | 367.4 (180.5) | − 21.2 (48.2) | − 12.0 (− 22, − 6) | 306.3 (51.2) | 352.3 (126.8) | + 46.0 (86.6) | + 8.0 (+ 1, + 79) | 0.15 |
| TMV (mm3) | 10.65 (1.97) | 10.42 (2.03) | − 0.23 (0.19) | − 0.20 (− 0.29, − 0.08) | 9.84 (1.31) | 10.09 (1.68) | + 0.26 (0.50) | + 0.07 (− 0.16, + 0.46) | 0.07* |
CST, central subfield thickness; BCVA, best-corrected visual acuity; DME, diabetic macular edema; TMV, total macular volume
aFor area of retinal neovascularization, sample sizes were 6 in the emixustat group and 10 in the placebo group, as the reading center could not determine this measurement at baseline and day 85 in all patients
*Statistically significant difference at the predefined level of 0.10 for this pilot study