Table 1.
Demographic and clinical characteristics at randomization by treatment group.
| Assigned Treatment | |||
|---|---|---|---|
| Characteristic | Periocular | Intravitreal | Dexamethasone |
| Person-level (Randomized individuals) | 65 | 63 | 64 |
| Age at enrollment (years), Median (Range) | 55 (22, 87) | 56 (18, 86) | 55 (19, 85) |
| Male, N (%) | 26 (40%) | 23 (37%) | 24 (38%) |
| Race/Ethnicity, N (%) | |||
| White | 46 (71%) | 37 (59%) | 39 (61%) |
| Hispanic | 1 (2%) | 3 (5%) | 5 (8%) |
| Black | 11 (17%) | 19 (30%) | 17 (27%) |
| Other | 7 (11%) | 4 (6%) | 3 (5%) |
| Smoking, N (%) | |||
| Current | 9 (14%) | 13 (21%) | 9 (14%) |
| Former | 15 (23%) | 13 (21%) | 20 (31%) |
| Never | 41 (63%) | 37 (59%) | 35 (55%) |
| Bilateral uveitis, N (%) | 49(75%) | 51 (81%) | 47 (73%) |
| Bilateral macular edema, N (%) | 9 (14%) | 19 (30%) | 15 (23%) |
| On systemic medications*, N (%) | 24 (37%) | 23 (37%) | 23 (36%) |
| Primary uveitis diagnosis†, N (%) | |||
| Anterior | 11 (17%) | 8 (13%) | 10 (16%) |
| Anterior/Intermediate | 13 (20%) | 7 (11%) | 14 (22%) |
| Intermediate | 17 (26%) | 14 (22%) | 15 (23%) |
| Posterior | 13 (20%) | 15 (24%) | 9 (14%) |
| Panuveitis | 11 (17%) | 19 (30%) | 16 (25%) |
| Any uveitis associated systemic disease, N (%) | 14 (22%) | 15 (24%) | 12 (19%) |
| Duration of uveitis (years), Median (Range) | 3.5 (0.0, 24.4) | 3.5 (0.0, 36.1) | 4.5 (0.0, 30.2) |
| Eye-level (Eligible eyes) | 74 | 82 | 79 |
| Intraocular pressure (mm Hg): Median (Range) | 14 (6, 22) | 14 (7, 21) | 13 (6, 20) |
| Cup to disc ratio: Median (Range) | 0.2 (0.0, 0.8) | 0.3 (0.0, 0.8) | 0.3 (0.0, 0.8) |
| VA (standard letters): Median (Range) | 68 (25, 91) | 63 (13, 88) | 64 (23, 86) |
| Snellen equivalent | 20/44 | 20/55 | 20/53 |
| VA worse than 20/40, N (%) | 43 (58%) | 60 (73%) | 50 (63%) |
| Active uveitis, N (%) | 48 (65%) | 68 (83%) | 57 (72%) |
| Aphakic or pseudophakic, N (%) | 36 (49%) | 47 (57%) | 46 (58%) |
| Glaucoma, N (%) | 5 (7%) | 11 (13%) | 8 (10%) |
| Prior treatment, N (%) | |||
| Periocular | 36 (49%) | 31 (38%) | 37 (47%) |
| Intravitreal | 22 (30%) | 22 (27%) | 24 (30%) |
| Ozurdex | 8 (11%) | 11 (13%) | 13 (16%) |
| Retisert | 6 (8%) | 4 (5%) | 6 (8%) |
| IOP lowering medications | 16 (22%) | 16 (20%) | 19 (24%) |
| IOP lowering surgery | 9 (12%) | 5 (6%) | 12 (15%) |
| OCT characteristics | |||
| Retinal thickness at the center subfield, Median (Range) | 438 (278, 922) | 485 (236, 824) | 449 (243, 1300) |
| Cystoid spaces, N (%) | 70 (95%) | 76 (95%) | 77 (97%) |
| Subretinal fluid, N (%) | 29 (39%) | 41 (51%) | 28 (35%) |
| FA leakage central subfield, N (%) | |||
| None (No ML) | 2 (3%) | 2 (3%) | 3 (4%) |
| Partial (0 < ML < 0.44 DA) | 14 (19%) | 16 (20%) | 11 (14%) |
| Complete (0.44 DA) | 57 (78%) | 62 (78%) | 62 (82%) |
*
Baseline form data does not confirm systemic therapy for two patients in systemic therapy strata.
†
The categories represent the location of the primary diagnosis and are mutually exclusive.
N = number; % = percent; IOP = intraocular pressure; VA = visual acuity; OCT = optical coherence tomography; ML = macular leakage; DA = disk area.