Introduction
Methods
Results
Study population
Visit windowa
| Patients seen within visit vindow (n) | Patients with BCVA assessment (n) | Mean time until BCVA assessment (days) | Patients with OCT assessment (n) | Mean time until OCT assessment (days) |
---|---|---|---|---|---|
Baseline | 573 | 566 | 378 | ||
Week 6 | 436 | 436 | 38 | 172 | 42 |
Week 12 | 380 | 380 | 95 | 198 | 95 |
Week 24 | 316 | 316 | 161 | 158 | 158 |
Week 36 | 87 | 87 | 240 | 37 | 238 |
Week 48 | 26 | 26 | 369 | 11 | 363 |
Parameter | Total population (n = 573) | BRVO (n = 367) | CRVO(n = 206) |
---|---|---|---|
Mean age, years (SD) | 72.1 (10.6) | 72.1 (10.6) | 72.2 (10.4) |
Range | 35–94 | 35–94 | 40–89 |
Gender, n (%) | |||
Male | 287 (50.1) | 177 (48.2) | 110 (53.4) |
Female | 286 (49.9) | 190 (51.8) | 96 (46.6) |
Median time since diagnosis, years | 0.14 | 0.14 | 0.15 |
Ischemic, n (%) | |||
Yes | 126 (22.0) | 74 (20.2) | 52 (25.2) |
No | 447 (78.0) | 293 (79.8) | 154 (74.8) |
Median days since onset of ME symptoms | 97 | 98 | 94.5 |
< 90 days, n (%) | 268 (46.8) | 170 (46.3) | 98 (47.6) |
90–180 days, n (%) | 99 (17.3) | 57 (15.5) | 42 (20.4) |
> 180 days, n (%) | 206 (36.0) | 140 (38.2) | 66 (32.0) |
Lens status in study eye, n (%) | |||
Phakic | 312 (54.5) | 189 (51.5) | 123 (59.7) |
Pseudophakic | 42 (7.3) | 26 (7.1) | 16 (7.8) |
Not reporteda
| 219 (38.2) | 152 (41.4) | 67 (32.5) |
Glaucoma in study eye, n (%) | 56 (9.8) | 35 (9.5) | 21 (10.2) |
Mean BCVA, logMAR (SD)b
| 0.67 (0.39) | 0.61 (0.36) | 0.79 (0.41) |
Approximate Snellen | 20/100 | 20/80 | 20/125 |
Approximate ETDRS letter score | 51 | 54 | 45 |
Mean CRT, μm (SD) | 501 (169) | 476 (145) | 546 (198) |
History of previous RVO treatment (study eye), n (%) | |||
Yes | 234 (40.8) | 147 (40.1) | 87 (42.2) |
Procedurec
| 110 (19.2) | 74 (20.2) | 36 (17.5) |
Drug-based therapy | 215 (37.5) | 135 (36.8) | 80 (38.8) |
Bevacizumab | 126 (22.0) | 80 (21.8) | 46 (22.3) |
Ranibizumab | 90 (15.7) | 56 (15.3) | 34 (16.5) |
Triamcinolone acetonide | 10 (1.7) | 2 (0.5) | 8 (3.9) |
Other | 38 (6.6) | 22 (6.0) | 16 (7.8) |
No | 319 (55.7) | 210 (57.2) | 109 (52.9) |
Not reported | 20 (3.5) | 10 (2.7) | 10 (4.9) |
Treatment
Parameter | Total population (n = 573) | BRVO (n = 367) | CRVO (n = 206) |
---|---|---|---|
Number of DEX implant injections, no. of patients (%) | |||
1 | 483 (84.3) | 305 (83.1) | 178 (86.4) |
2 | 85 (14.8) | 58 (15.8) | 27 (13.1) |
3 | 5 (0.9) | 4 (1.1) | 1 (0.5) |
For patients who received second injection (n = 90 total): | |||
Mean days from first to second injection (SD) | 155 (47) | 151 (42) | 164 (56) |
Range | 59–378 | 59–337 | 92–378 |
For patients who received third injection (n = 5 total): | |||
Mean days from first to third injection (SD) | 314 (74) | 324 (82) | 277 (NA) |
Range | 237–405 | 237–405 | (NA) |
Mean days from second to third injection (SD) | 166 (61) | 178 (64) | 120 (NA) |
Range | 105–245 | 105–245 | (NA) |
Parameter, n (%) | Total population (n = 573) | BRVO (n = 367) | CRVO (n = 206) |
---|---|---|---|
Patients who used other RVO treatment in addition to DEX implant | 114 (19.9) | 57 (15.5) | 57 (27.7) |
Type of other RVO treatment | |||
Laser | 83 (14.5) | 47 (12.8) | 36 (17.5) |
Panretinal photocoagulation | 25 (4.4) | 7 (1.9) | 18 (8.7) |
Focal retinal laser | 17 (3.0) | 15 (4.1) | 2 (1.0) |
Grid laser, unspecified, or other | 41 (7.2) | 25 (6.8) | 16 (7.8) |
Anti-VEGF | 26 (4.5) | 12 (3.3) | 14 (6.8) |
Ranibizumab | 14 (2.4) | 8 (2.2) | 6 (2.9) |
Bevacizumab | 10 (1.7) | 3 (0.8) | 7 (3.4) |
Aflibercept | 2 (0.3) | 1 (0.3) | 1 (0.5) |
Pars plana vitrectomy | 4 (0.7) | 0 (0) | 4 (1.9) |
Cryocoagulation | 4 (0.7) | 0 (0) | 4 (1.9) |
Other | 7 (1.2) | 3 (0.8) | 4 (1.9) |
Unknown | 9 (1.6) | 3 (0.8) | 6 (2.9) |
Efficacy
Visual outcomes
Total analysis population (n = 573) | ||
---|---|---|
Visit windowb
| Mean logMAR (SD) | Mean approximate ETDRS letters (SD) |
Baseline (n = 539) | 0.673 (0.387) | 51.4 (19.3) |
Week 6 (n = 418) | 0.493 (0.378) | 60.3 (18.9) |
Week 12 (n = 365) | 0.522 (0.414) | 58.9 (20.7) |
Week 24 (n = 297) | 0.551 (0.426) | 57.5 (21.3) |
Week 36 (n = 81) | 0.550 (0.457) | 57.5 (22.8) |
Week 48 (n = 24) | 0.538 (0.447) | 58.1 (22.3) |
Anatomic outcomes
Safety
Treatment or procedure, n (%) | Total population (n = 573) | BRVO (n = 367) | CRVO (n = 206) |
---|---|---|---|
Glaucoma incisional surgery | 0 (0) | 0 (0) | 0 (0) |
Laser trabeculoplasty | 9 (1.6) | 6 (1.6) | 3 (1.5) |
Among patients who had laser: | |||
Baseline use of IOP-lowering medication | 1 (11.1) | 0 (0) | 1 (33.3) |
Started IOP-lowering medication during study | 1 (11.1) | 1 (16.7) | 0 (0) |
No use of IOP-lowering medication during study | 7 (77.8) | 5 (83.3) | 2 (66.7) |
Among all patients: | |||
IOP-lowering medication used at baseline | 42 (7.3) | 21 (5.7) | 21 (10.2) |
IOP-lowering medication used during study | 95 (16.6) | 52 (14.2) | 43 (20.9) |