Table 1.
Baseline characteristics of eyes included and excluded from the study
| Eyes Included | Eyes Excluded* | |||
|---|---|---|---|---|
| Ranibizumab N = 77 |
Prompt PRP N = 69 |
Ranibizumab N = 114 |
Prompt PRP N = 134 |
|
| Participant Characteristics | ||||
| Gender: Women - N (%) | 33 (43%) | 30 (43%) | 50 (44%) | 62 (46%) |
| Participants with 2 study eyes - N (%) | 36 (47%) | 31 (45%) | 53 (46%) | 58 (43%) |
| Age (yrs) - Median (25th, 75th percentile) | 52 (44, 59) | 50 (42,57) | 52 (45,59) | 52 (45,60) |
| Race/Ethnicity – N (%) | ||||
| White | 49 (64%) | 40 (58%) | 51 (45%) | 61 (46%) |
| Black/African American | 7 (9%) | 9 (13%) | 31 (27%) | 34 (25%) |
| Hispanic or Latino | 18 (23%) | 16 (23%) | 30 (26%) | 35 (26%) |
| Asian | 2 (3%) | 3 (4%) | 0 | 0 |
| American Indian/Alaskan Native | 1 (1%) | 0 (0%) | 0 | 0 |
| More than one race | 0 | 1 (1%) | 0 | 1 (1%) |
| Unknown/not reported | 0 | 0 | 2 (2%) | 3 (2%) |
| Duration of Diabetes (yrs) - Median (25th, 75th percentile) | 19 (13, 26) | 16 (11, 23) | 18 (11,24) | 17 (11,24) |
| Diabetes Type | ||||
| Type 1 | 21 (27%) | 11 (16%) | 22 (19%) | 30 (22%) |
| Type 2 | 52 (68%) | 55 (80%) | 88 (77%) | 100 (75%) |
| Uncertain | 4 (5%) | 3 (4%) | 4 (4%) | 4 (3%) |
| Ocular Characteristics | ||||
| Diabetic Retinopathy Severity† (ETDRS level) | ||||
| Severe NPDR or less | 11 (15%) | 9 (14%) | 8 (7%) | 17 (13%) |
| Prior PRP; without current PDR (level 60) | 0 | 0 | 0 | 1 (1%) |
| Mild PDR (level 61) | 13 (17%) | 13 (20%) | 17 (15%) | 18 (14%) |
| Moderate PDR (level 65) | 35 (47%) | 21 (32%) | 33 (29%) | 46 (35%) |
| High risk PDR (level 71 and 75) | 15 (20%) | 23 (35%) | 54 (47%) | 50 (38%) |
| Advanced PDR (level 81 and 85) | 1 (1%) | 0 (0%) | 2 (2%) | 1 (1%) |
| Visual Acuity | ||||
| Letter Score - Median (25th, 75th percentile) | 80 (75, 86) | 81 (71,87) | 76 (68,82) | 76 (69,82) |
| ~Snellen Equivalent - Median (25th, 75th percentile) | 20/25 (20/32, 20/20) | 20/25 (20/40, 20/20 | 20/32 (20/50, 20/25) | 20/32 (20/40, 20/25) |
| OCT Central Subfield Thickness (µm, Stratus equivalent) - Median (25th, 75th percentile) | 219 (196, 252) | 227 (204, 261) | 228 (197,287) | 234 (202,266) |
| Intraocular Pressure (mmHg) - Median (25th, 75th percentile) | 15 (12,17) | 16 (12,18) | 15 (13,18) | 15 (13,17) |
PRP = panretinal photocoagulation; ETDRS = Early Treatment Diabetic Retinopathy Study; NPDR = non-proliferative diabetic retinopathy; PDR = proliferative diabetic retinopathy; OCT = optical coherence tomography.
Participants were excluded if they enrolled prior to implementation of the retinal nerve fiber layer (RNFL) ancillary study (N = 145 eyes); quality of the baseline images were determined to be unacceptable by a central reading center (Duke University Reading Center, N = 59 eyes). Unacceptable baseline measurements were caused by image acquisition errors such as boundary line issues and centration issues (N = 59). Forty-one eyes had at least one of the following: 1) vitreomacular adhesion deformation, 2) epiretinal membrane or 3) hemorrhage (N = 6 eyes); participant was lost to follow-up prior to the 1-year visit (N = 27 eyes); image quality of the RNFL was graded as either poor or grades were missing at both annual follow-up visits (N = 13 eyes); the RNFL was measured on an imaging device different from that used at baseline (N = 4 eyes)
Five missing: 2 from the Ranibizumab group and 3 from the PRP group among those included in this analyses; 1 missing from the PRP group among participants excluded