Table 1. Baseline Subject Characteristics According to Treatment Group.
| Laser N=330 eyes |
1 mg N=256 eyes |
4 mg N=254 eyes |
|
|---|---|---|---|
| Gender: Women - N(%) | 166(50%) | 120(47%) | 125(49%) |
| Age (yrs) - Median (25th, 75th percentile) | 63 (57, 69) | 63 (58, 70) | 63 (57, 69) |
| Race- N(%) | |||
| White | 243(74%) | 186(73%) | 183(72%) |
| African-American | 31(9%) | 22(9%) | 26(10%) |
| Hispanic or Latino | 39(12%) | 34(13%) | 33(13%) |
| Asian | 7(2%) | 8(3%) | 5(2%) |
| American Indian/Alaskan Native | 2(1%) | 2(1%) | 2(1%) |
| Native Hawaiian/Other Pacific Islander | 1(<1%) | 0 | 1(<1%) |
| More than one race | 1(<1%) | 1(<1%) | 0 |
| Unknown/not reported | 6(2%) | 3(1%) | 4(2%) |
| Diabetes Type- N(%) | |||
| Type 1 | 14(4%) | 12(5%) | 12(5%) |
| Type 2 | 316(96%) | 244(95%) | 242(95%) |
| Duration of Diabetes (yrs)- Median (25th, 75th percentile) | 15 (9, 21) | 15 (9, 21) | 16 (10, 22) |
| HbA1c* - Median (25th, 75th percentile) | 7.5 (6.6, 8.5) | 7.5 (6.8, 8.4) | 7.6 (6.8, 8.8) |
| Prior photocoagulation for Diabetic Macular Edema – N(%) | 198(60%) | 154(60%) | 158(62%) |
| Prior Panretinal Scatter Photocoagulation – N(%) | 53(16%) | 40(16%) | 42(17%) |
| Intraocular Pressure (mmHg)-Median (25th, 75th percentile) | 16 (13, 18) | 16 (13, 18) | 16 (14, 18) |
| History of Ocular Hypertension – N(%) | 3(1%) | 8(3%) | 4(2%) |
| Lens Status Phakic (clinical exam) - N(%) | 262(79%) | 203(79%) | 197(78%) |
| Baseline Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) Visual Acuity (letter score) | |||
| Median (25th, 75th percentile) | 62 (53, 67) | 62 (54, 67) | 62 (52, 67) |
| Randomization Strata- N(%) | |||
| 73-60 (20/40 to 20/63) | 189 (57%) | 149 (58%) | 149 (59%) |
| 59-36 (<20/63 to >20/200) | 129 (39%) | 94 (37%) | 92 (36%) |
| 35-24 (20/200 to 20/320) | 12 (4%) | 13 (5%) | 13 (5%) |
| Central Subfield Thickness(microns) on Optical Coherence Tomography (OCT) -Median(25th, 75 th percentile) †‡ § | 398 (329, 505) | 405 (327, 514) | 396 (323, 484) |
| Retinal Volume (mm3) on OCT -Median (25th, 75 th percentile) †‡ | 9.2 (7.9, 10.6) | 8.9 (7.8, 10.5) | 8.9 (7.9, 10.0) |
| OCT Cystoid Abnormality (questionable or definite)- N(%)† | 315 (96%) | 243 (96%) | 246 (98%) |
| OCT Subretinal Fluid Present (questionable or definite)-N(%)†‖ | 94 (29%) | 64 (25%) | 61 (24%) |
| Retinopathy Severity (ETDRS Severity Scale)-N(%)† | |||
| Microaneurysms only (level 20) | 1 (<1%) | 1 (<1%) | 0 |
| Mild to moderately severe non-proliferative (level 35, 43, 47) | 186 (58%) | 156 (63%) | 151 (62%) |
| Severe non-proliferative (level 53) | 43 (14%) | 27 (11%) | 25 (10%) |
| Mild to moderate proliferative (level 60, 61, 65) | 79 (25%) | 56 (23%) | 62 (25%) |
| High risk proliferative (level 71, 75) | 9 (3%) | 8 (3%) | 6 (2%) |
Subjects with two study eyes are counted in one of the triamcinolone groups and in the laser group.
*
Missing HbA1c data in 64, 46, and 50 in the laser, 1 mg, and 4 mg groups respectively
†
Missing (or ungradeable) OCT and fundus photograph data as follows for the laser, 1 mg, and 4 mg groups respectively: central subfield (1,2,1), retinal volume (47, 36, 48), cystoid abnormality (3,4,2), subretinal fluid (1,4,1), retinopathy severity (12,8,10).
‡
mean of two baseline scans
§
mean central subfield thickness was < 250 microns based on reading center grading in 15, 7, and 5 eyes for the laser, 1 mg, and 4 mg groups respectively
‖
within center or outside of center