Change in square root transformed area from baseline for RORA and each feature at 6, 12 and 18 months
(A) Change in square root area of RORA from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | 0.162 (0.152) | N/A | 0.104 (0.170) | N/A | 0.0510 (0.144) | N/A |
Median (Min, Max) | 0.137 (−0.268, 0.691) | 0.098 (−0.642, 0.533) | 0.0496 (−0.479, 0.389) | |||
12 months | N=58 | N=52 | N=56 | |||
Mean (SD) | 0.277 (0.209) | N/A | 0.202 (0.256) | 0.09 | 0.151 (0.142) | 0.004 |
Median (Min, Max) | 0.23 (−0.244, 0.810) | 0.168 (−0.422, 0.921) | 0.14 (−0.250, 0.587) | |||
18 months | N=58 | N=55 | N=62 | |||
Mean (SD) | 0.396 (0.256) | N/A | 0.315 (0.395) | 0.15 | 0.251 (0.193) | 0.04 |
Median (Min, Max) | 0.347 (−0.215, 1.04) | 0.293 (−1.25, 1.30) | 0.242 (−0.193, 0.937) |
(B) Change in square root area of PRD from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | −0.0363 (0.255) | N/A | −0.00442 (0.362) | N/A | 0.0243 (0.387) | N/A |
Median (Min, Max) | −0.0358 (−1.02, 0.575) | −0.0104 (−0.871, 2.15) | −0.0203 (−0.659, 1.77) | |||
12 months | N=58 | N=52 | 0.34 | N=56 | 0.12 | |
Mean (SD) | −0.0185 (0.316) | N/A | −0.00234 (0.404) | 0.000414 (0.431) | ||
Median (Min, Max) | 0.0124 (−1.33, 0.457) | −0.0395 (−0.962, 1.57) | −0.0413 (−1.26, 2.22) | |||
18 months | N=58 | N=55 | 0.56 | N=62 | 0.67 | |
Mean (SD) | −0.0296 (0.375) | N/A | −0.0533 (0.426) | 0.0417 (0.486) | ||
Median (Min, Max) | −0.0512 (−0.824, 1.27) | −0.085 (−1.05, 1.48) | 0.00812 (−1.04, 2.27) |
(C) Change in square root area of PRD in isolation from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | 0.0975 (0.191) | N/A | 0.0790 (0.273) | N/A | 0.0740 (0.322) | N/A |
Median (Min, Max) | 0.13 (−0.580, 0.496) | 0.0757 (−0.814, 1.45) | 0.0664 (−0.520, 1.60) | |||
12 months | N=58 | N=52 | N=56 | |||
Mean (SD) | 0.219 (0.238) | N/A | 0.155 (0.241) | 1 | 0.113 (0.333) | 1 |
Median (Min, Max) | 0.207 (−0.657, 0.730) | 0.107 (−0.492, 0.896) | 0.0837 (−1.01, 1.81) | |||
18 months | N=58 | N=55 | N=62 | |||
Mean (SD) | 0.301 (0.278) | N/A | 0.217 (0.400) | 0.81 | 0.224 (0.352) | 0.73 |
Median (Min, Max) | 0.299 (−0.496, 1.08) | 0.212 (−1.44, 0.993) | 0.183 (−0.778, 1.83) |
(D) Change in square root area of RPE loss from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | 0.161 (0.151) | N/A | 0.107 (0.155) | N/A | 0.0761 (0.153) | N/A |
Median (Min, Max) | 0.134 (−0.258, 0.645) | 0.0973 (−0.446, 0.579) | 0.0565 (−0.293, 0.493) | |||
12 months | N=58 | N=52 | N=56 | |||
Mean (SD) | 0.287 (0.197) | N/A | 0.198 (0.242) | 0.03 | 0.147 (0.158) | <0.001 |
Median (Min, Max) | 0.241 (−0.235, 0.830) | 0.168 (−0.368, 1.06) | 0.15 (−0.276, 0.587) | |||
18 months | N=58 | N=55 | N=62 | |||
Mean (SD) | 0.410 (0.264) | N/A | 0.314 (0.369) | 0.09 | 0.242 (0.200) | 0.008 |
Median (Min, Max) | 0.384 (−0.202, 1.13) | 0.291 (−0.997, 1.25) | 0.247 (−0.202, 0.904) |
(E) Change in square root area of hypertransmission from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | 0.139 (0.153) | N/A | 0.130 (0.206) | N/A | 0.0816 (0.157) | N/A |
Median (Min, Max) | 0.12 (−0.339, 0.635) | 0.113 (−0.744, 0.881) | 0.0917 (−0.414, 0.508) | |||
12 months | N=58 | N=52 | N=56 | |||
Mean (SD) | 0.239 (0.192) | N/A | 0.220 (0.233) | 0.82 | 0.211 (0.212) | 0.82 |
Median (Min, Max) | 0.214 (−0.329, 0.747) | 0.188 (−0.167, 0.960) | 0.184 (−0.231, 1.01) | |||
18 months | N=58 | N=55 | N=62 | |||
Mean (SD) | 0.356 (0.223) | N/A | 0.306 (0.366) | 0.38 | 0.288 (0.190) | 0.38 |
Median (Min, Max) | 0.349 (−0.301, 1.00) | 0.289 (−1.49, 0.999) | 0.27 (−0.189, 0.750) |
(F) Change in square root of intact macula area from baseline to 18 months (mm) | ||||||
Sham pooled | P value | PEOM | P value | PM | P value | |
6 months | N=61 | N=61 | N=63 | |||
Mean (SD) | −0.124 (0.238) | N/A | −0.111 (0.328) | N/A | −0.0733 (0.303) | N/A |
Median (Min, Max) | −0.123 (−0.867, 0.570) | −0.0793 (−1.74, 0.870) | −0.0447 (−1.44, 0.550) | |||
12 months | N=58 | N=52 | N=56 | |||
Mean (SD) | −0.259 (0.291) | N/A | −0.180 (0.306) | 0.18 | −0.0878 (0.319) | 0.01 |
Median (Min, Max) | −0.249 (−0.893, 0.558) | −0.136 (−0.991, 0.805) | −0.0807 (−1.64, 1.02) | |||
18 months | N=58 | N=55 | N=62 | |||
Mean (SD) | −0.354 (0.316) | N/A | −0.339 (0.384) | 0.75 | −0.207 (0.312) | 0.04 |
Median (Min, Max) | −0.358 (−1.24, 0.510) | −0.302 (−1.34, 0.775) | −0.179 (−1.64, 0.803) |
Table shows mean square root change of area, SD and p values for comparison of pegetacoplan EOM or monthly versus sham pooled when considering (A) RORA, (B) PRD, (C) PRD in isolation from baseline to 18 months, (D) RPE loss from baseline to 18 months, (E) hypertransmission and (F) intact macula.
EOM, every other month; N, number of study eyes; PM, pegcetacoplan monthly; PRD, photoreceptor degeneration; RORA, RPE and outer retinal atrophy; RPE, retinal pigment epithelium.