Table 1.
Baseline Study Participant and Ocular Characteristics
| Sham+ Focal/Grid/PRP Laser N = 123 |
Ranibizumab+ Focal/Grid/PRP Laser N = 113 |
Triamcinolone+ Focal/Grid/PRP Laser N = 109 |
|
|---|---|---|---|
| Women, no. (%) | 44 (36%) | 48 (42%) | 44 (40%) |
| Age (yrs) Median (25th, 75th percentile) | 54 (45, 61) | 57 (48, 64) | 58 (49, 64) |
| Race, no. (%) | |||
| White | 76 (62%) | 72 (64%) | 61 (56%) |
| African-American | 11 (9%) | 15 (13%) | 18 (17%) |
| Hispanic or Latino | 31 (25%) | 23 (20%) | 27 (25%) |
| Asian | 3 (2%) | 1 (1%) | 2 (2%) |
| American Indian/Alaskan Native | 1 (1%) | 0 | 1 (1%) |
| Native Hawaiian/Other Pacific Islander | 0 | 1 (1%) | 0 |
| Unknown/not reported | 1 (1%) | 1 (1%) | 0 |
| Diabetes type, no. (%) | |||
| Type 1 | 20 (16%) | 13 (12%) | 12 (11%) |
| Type 2 | 101 (82%) | 93 (82%) | 95 (87%) |
| Uncertain | 2 (2%) | 7 (6%) | 2 (2%) |
| Duration of diabetes (yrs) Median (25th, 75th percentile) * | 15 (8, 21) | 15 (10, 21) | 15 (10, 19) |
| Hemoglobin A1c Median (25th, 75th percentile)† | 7.9 (7.0, 9.6) | 8.1 (7.1, 9.9) | 8.1 (7.0, 9.7) |
| Prior cardiovascular event, no. (%) ‡ | 21 (17%) | 35 (31%) | 28 (26%) |
| Hypertension, no. (%) | 97 (79%) | 88 (78%) | 82 (75%) |
| Number of study eyes | |||
| 1 study eye | 97 (79%) | 100 (88%) | 96 (88%) |
| 2 study eyes | 26 (21%) | 13 (12%) | 13 (12%) |
| Prior scatter photocoagulation§, no. (%) | 16 (13%) | 20 (18%) | 19 (17%) |
| No prior treatment for DME, no. (%) | 80 (65%) | 75 (66%) | 72 (66%) |
| Prior laser for DME, no. (%) | 40 (33%) | 33 (29%) | 36 (33%) |
| Prior intravitreal triamcinolone for DME, no. (%) | 1 (1%) | 9 (8%) | 3 (3%) |
| Prior vitrectomy for DME, no. (%) | 2 (2%) | 0 | 0 |
| Prior peribulbar triamcinolone for DME, no. (%) | 1 (1%) | 0 | 1 (1%) |
| Prior anti-VEGF for DME, no. (%) | 6 (5%) | 1 (1%) | 3 (3%) |
| IOP (mmHg) Median (25th, 75th percentile) | 15 (13, 18) | 16 (14, 18) | 15 (13, 18) |
| Currently on IOP lowering medicine for glaucoma or ocular hypertension, no. (%) | 0 | 3 (3%) | 0 |
| Lens status (clinical exam), no. (%) | |||
| Phakic | 111 (90%) | 91 (81%) | 99 (91%) |
| Pseudophakic | 12 (10%) | 22 (19%) | 10 (9%) |
| Classification of DME (clinical exam), no. (%) | |||
| Predominantly focal | 37 (30%) | 19 (17%) | 27 (25%) |
| Neither predominantly focal or diffuse | 18 (15%) | 25 (22%) | 14 (13%) |
| Predominantly diffuse | 68 (55%) | 69 (61%) | 68 (62%) |
| Baseline visual acuity letter score (approximate Snellen equivalent) by randomization strata | |||
| Median (25th, 75th percentile) | 67 (52, 75) | 68 (56, 75) | 67 (59, 75) |
| ≥66 (better than 20/50) | 66 (54%) | 64 (57%) | 61 (56%) |
| ≤65 (20/50 or worse) | 57 (46%) | 49 (43%) | 48 (44%) |
| Baseline visual acuity letter score (approximate Snellen equivalent) | |||
| 93–89 (20/16) | 0 | 0 | 3 (3%) |
| 88–84 (20/20) | 7 (6%) | 8 (7%) | 6 (6%) |
| 83–79 (20/25) | 10 (8%) | 8 (7%) | 5 (5%) |
| 78–74 (20/32) | 22 (18%) | 24 (21%) | 23 (21%) |
| 73–69 (20/40) | 20 (16%) | 15 (13%) | 10 (9%) |
| 68–64 (20/50) | 11 (9%) | 14 (12%) | 23 (21%) |
| 63–59 (20/63) | 11 (9%) | 10 (9%) | 14 (13%) |
| 58–54 (20/80) | 8 (7%) | 11 (10%) | 7 (6%) |
| 53–49 (20/100) | 6 (5%) | 7 (6%) | 3 (3%) |
| 48–44 (20/125) | 7 (6%) | 6 (5%) | 4 (4%) |
| 49–43 (20/160) | 7 (6%) | 5 (4%) | 5 (5%) |
| 38–34 (20/200) | 6 (5%) | 2 (2%) | 5 (5%) |
| 33–29 (20/250) | 4 (3%) | 1 (1%) | 1 (1%) |
| 28–24 (20/320) | 4 (3%) | 2 (2%) | 0 |
|
Central subfield thickness (μm) on OCT|| Median (25th,75th percentile) |
355 (285, 510) | 352 (283, 476) | 359 (271, 472) |
|
Retinal volume (mm3) on OCT|| Median (25th,75th percentile) |
9.4 (8.4, 10.6) | 9.2 (8.3, 11.0) | 9.1 (8.1, 10.0) |
| OCT cystoid abnormality** (questionable or definite), no. (%) | 108 (88%) | 96 (86%) | 93 (88%) |
| OCT subretinal fluid present** (questionable or definite), no. (%) | 30 (24%) | 31 (28%) | 32 (30%) |
| ETDRS Retinopathy severity level (ETDRS description) from photograph grading, no. (%) | |||
| Level 35, 43 (Mild/Moderate NPDR) | 6 (5%) | 5 (5%) | 6 (6%) |
| Level 47 (Moderately severe NPDR) | 26 (22%) | 15 (14%) | 10 (10%) |
| Level 53 (Severe NPDR) | 5 (4%) | 6 (6%) | 5 (5%) |
| Level 60 (Prior PRP without active neovascularization) | 2 (2%) | 4 (4%) | 3 (3%) |
| Level 61 (Mild/Moderate PDR) | 48 (40%) | 36 (33%) | 38 (36%) |
| Level 71, 75 (High-risk PDR) | 32 (27%) | 43 (39%) | 43 (41%) |
DME = diabetic macular edema; ETDRS = Early Treatment Diabetic Retinopathy Study; VEGF = vascular endothelial growth factor; IOP = intraocular pressure;; NPDR = non-proliferative diabetic retinopathy; PRP = panretinal photocoagulation; PDR = proliferative diabetic retinopathy.
For study participants that answered ‘Uncertain’ type of diabetes was imputed using the age the study participant first started using insulin treatment.
Missing Hemoglobin A1c data for study participants in the sham+ focal/grid/PRP laser, ranibizumab+ focal/grid/PRP laser, and triamcinolone+ focal/grid/PRP laser groups, respectively: 3, 10, and 6.
Includes any pre-existing cardiovascular condition.
Per eligibility criteria the investigator believed that there was still room for 1200–1600 burns.
Missing (or ungradeable) optical coherence tomography (OCT) and fundus photograph data as follows for the laser+ focal/grid/PRP laser, ranibizumab+ focal/grid/PRP laser, and triamcinolone+ focal/grid/PRP laser groups, respectively: central subfield (1, 1, and 2), retinal volume (41, 35, and 38), cystoids change (0, 1, and 3) and retinopathy severity (4, 4, and 4).
From reading center grading.