Table 2.
Panretinal Photocoagulation Treatment
| Sham+ Focal/Grid/PRP Laser | Ranibizumab+ Focal/Grid/PRP Laser | Triamcinolone+ Focal/Grid/PRP Laser | |
|---|---|---|---|
|
| |||
| N = 123 | N = 113 | N = 109 | |
| Initial PRP planned to start on the same day as focal/grid laser (declared prior to randomization), No. (%) | 71 (58%) | 66 (58%) | 65 (60%) |
| Initial PRP started on the same day as focal/grid laser, No. (%) | |||
| Yes | 68 (55%) | 69 (61%) | 60 (55%) |
| No | 54 (44%) | 41 (36%) | 46 (42%) |
| PRP and/or focal/grid laser not done | 1 (1%) | 3 (3%) | 3 (3%) |
| Initial PRP on the same day as focal/grid laser planned/performed, No. (%) | |||
| Yes/Yes | 62 (50%) | 60 (53%) | 54 (50%) |
| Yes/No | 8 (7%) | 4 (4%) | 9 (8%) |
| No/Yes | 6 (5%) | 9 (8%) | 6 (6%) |
| No/No | 46 (37%) | 37 (33%) | 37 (34%) |
| PRP and/or focal/grid laser not done | 1 (1%) | 3 (3%) | 3 (3%) |
| Number of PRP sittings investigator planned to perform (declared prior to randomization), No. (%) | |||
| 1 | 47 (38%) | 40 (35%) | 44 (40%) |
| 2 | 57 (46%) | 54 (48%) | 47 (43%) |
| 3 | 19 (15%) | 19 (17%) | 18 (17%) |
| Number of PRP sittings performed, No. (%) | |||
| 1 | 49 (40%) | 38 (34%) | 41 (38%) |
| 2 | 58 (47%) | 56 (50%) | 50 (46%) |
| 3 | 15 (12%) | 16 (14%) | 16 (15%) |
| 4 | 0 | 1 (1%) | 0 |
| PRP not done | 1 (1%) | 2 (2%) | 2 (2%) |
| Number of PRP sittings planned/performed, No. (%) | |||
| 1/1 | 46 (37%) | 37 (33%) | 40 (37%) |
| 1/2 | 1 (1%) | 3 (3%) | 4 (4%) |
| 2/2 | 54 (44%) | 50 (44%) | 44 (40%) |
| 2/1 or 3 | 2 (2%) | 2 (2%) | 2 (2%) |
| 3/3 | 15 (12%) | 15 (13%) | 15 (14%) |
| 3/1 or 2 or 4 | 4 (3%) | 4 (4%) | 2 (2%) |
| PRP not done | 1 (1%) | 2 (2%) | 2 (2%) |
|
| |||
| N = 122 | N = 111 | N = 107 | |
| Proportion of Eyes with PRP Completed in the protocol window (49 days from randomization)* | 108 (89%) | 97 (87%) | 87 (81%) |
| Number of days from randomization to last PRP sitting* | 26 (14, 41) | 30 (14, 43) | 28 (14, 42) |
| Median (25th, 75th quartiles) [range] | [3, 71] | [3, 171] | [3, 72] |
| Retrobulbar or peribulbar anesthesia used*, No. (%) | 23 (19%) | 14 (13%) | 22 (21%) |
| PRP completed in 1 sitting | 15 (31%) | 9 (24%) | 17 (41%) |
| PRP completed in Multiple sittings (anesthesia administered during at least 1 sitting) | 8 (11%) | 5 (7%) | 5 (8%) |
| PRP automated pattern used*, No. (%) | 36 (30%) | 21 (19%) | 21 (20%) |
| PRP completed in 1 sitting | 13 (27%) | 7 (18%) | 5 (12%) |
| PRP completed in Multiple sittings | 23 (32%) | 14 (19%) | 16 (24%) |
| Indirect laser delivery system used*, No. (%) | 0 | 1 (1%) | 4 (4%) |
| PRP completed in 1 sitting | 0 | 0 | 1 (2%) |
| PRP completed in Multiple sittings | 0 | 1 (1%) | 3 (5%) |
| Total number of burns*† | |||
| Median (25th, 75th quartiles) | 1541 (1281, 1833) | 1410 (1252, 1634) | 1430 (1246, 1815) |
| Baseline retinopathy severity (reading center assessment): NPDR | 1448 (1276, 1805) | 1369 (1223, 1517) | 1416 (1259, 1589) |
| Baseline retinopathy severity (reading center assessment): PDR | 1600 (1305, 1842) | 1474 (1257, 1781) | 1457 (1243, 1835) |
NPDR= Nonproliferative diabetic retinopathy; PDR= Proliferative diabetic retinopathy; PRP=Panretinal Photocoagulation.
*
Exclude 5 eyes with PRP not performed
†
Exlcude 12 eyes with missing/nongradable retinopathy severity