Table 2.
Baseline Demographics and Clinical Characteristics According to Treatment Group
| mETDRS Group (N=162 eyes)* | MMG Group (N=161 eyes)* | |
|---|---|---|
| Subject Characteristics | ||
|
| ||
| Gender: Women - N(%) | 61(38%) | 69(43%) |
| Age (yrs) - Mean ± SD | 58 ± 11 | 59 ± 11 |
| Race – N(%) | ||
| White | 102(63%) | 103(64%) |
| African-American | 29(18%) | 31(19%) |
| Hispanic or Latino | 17(10%) | 13(8%) |
| Asian | 8(5%) | 7(4%) |
| Other | 6(4%) | 7(4%) |
| Diabetes Type - N(%) | ||
| Type 1 | 12(7%) | 9(6%) |
| Type 2 | 150(93%) | 152(94%) |
| Duration of Diabetes (years) - Mean±SD | 14±9 | 13±8 |
| HbA1c (%) - Mean±SD | 8.2±1.9 | 8.2±2.1 |
| Ocular Characteristics | ||
|
| ||
| E-ETDRS20 Visual Acuity (letter score) - N(%) | ||
| ≥ 84: 20/20 or better | 43(27%) | 32(20%) |
| 83–69: 20/25 to 20/40 | 76(47%) | 91(57%) |
| 68–49: 20/50 to 20/100 | 36(22%) | 27(17%) |
| 48–34: 20/125 to 20/200 | 7(4%) | 7(4%) |
| 33–19: 20/250–20/400 | 0(0%) | 4(2%) |
| Mean±SD – letters | 74±12 | 73±14 |
| OCT | ||
| Central Subfield Thickness (microns) Mean±SD | 335±128 | 346±118 |
| Maximum retinal thickening of central and inner subfields (microns, see text) Mean±SD | 148±122 | 163±111 |
| Number of eyes with at least 1 unthickened subfield† - N(%) | 97(60%) | 89(55%) |
| Fundus Photography | ||
| Retinopathy Severity21‡ - N(%) | ||
| Mild NPDR (level 35) | 25(15%) | 17(11%) |
| Moderate NPDR (level 43) | 21(13%) | 22(14%) |
| Moderately severe NPDR (level 47) | 79(49%) | 76(47%) |
| Severe NPDR (level 53) | 16(10%) | 29(18%) |
| Mild PDR (level 61) | 10(6%) | 9(6%) |
| Moderate PDR (level 65) | 5(3%) | 1(1%) |
| High Risk PDR (levels 71 and 75) | 0(0%) | 0(0%) |
| Clinically Significant Macular Edema23‡ - N(%) | ||
| None | 12(7%) | 10(6%) |
| Questionable | 3(2%) | 2(1%) |
| Zone of retinal thickening ≥ 1 disc area, within 1 disc diameter from center. | 6(4%) | 3(2%) |
| Retinal thickening or adjacent hard exudates ≤ 500μ from center but no thickening in center | 18(11%) | 17(11%) |
| Retinal thickening or adjacent hard exudates ≤ 500μ from center with questionable thickening in center | 19(12%) | 17(11%) |
| Retinal thickening or adjacent hard exudates ≤ 500μ from center with definite thickening in center | 99(61%) | 109(68%) |
| Area of Hard Exudates (within the Grid) | ||
| Mean ± SD - Disc Area | 0.1 ± 0.2 | 0.1 ± 0.2 |
| Area of Retinal Thickening (in the Inner Zone) | ||
| Mean ± SD - Disc Area | 1.7 ± 1.3 | 1.9 ± 1.3 |
| Area of Retinal Thickening (within the Grid) | ||
| Mean ± SD - Disc Area | 4.1 ± 3.4 | 5.0 ± 3.7 |
*
Subjects with two study eyes are included in both groups
†
Based on clinician assessment of the OCT
‡
Nongradable for up to 3% of eyes per group
Missing data for OCT and photographic measurements of up to 6 eyes per group