Table 5.
Baseline Capillary Loss Area within the ETDRS Macular Grid on FA (N=422 eyes for baseline analysis and N=244 eyes for change from baseline to 12 months analysis)
| Baseline Capillary Loss Within Grida | |||
|---|---|---|---|
| 0 | >0 | r | |
| Baseline VA letter score (Snellen equivalent)b | 0.06 | ||
| ≥84 (≥20/20) | 38 (28%) | 17 (22%) | |
| 83–69 (<20/20 to 20/40) | 63 (47%) | 46 (60%) | |
| 68–19 (<20/40 to 20/400) | 34 (25%) | 14 (18%) | |
| Total | 135 (100%) | 77 (100%) | |
| Baseline Central Subfield Thickness | 0.02 | ||
| < 300 | 61 (43%) | 42 (51%) | |
| 300 – < 425 | 55 (39%) | 23 (28%) | |
| ≥ 425 | 25 (18%) | 18 (22%) | |
| Total | 141 (100%) | 83 (100%) | |
| Baseline Total Macular Volumec | 0.09 | ||
| < 7 | 8 (7%) | 3 (4%) | |
| 7 – < 8 | 47 (44%) | 23 (32%) | |
| 8 – < 9 | 30 (28%) | 19 (27%) | |
| ≥ 9 | 23 (21%) | 26 (37%) | |
| Total | 108 (100%) | 71 (100%) | |
| Baseline DME Area Within the Grid | 0.24 | ||
| < 4 DA | 87 (62%) | 33 (40%) | |
| ≥4 DA | 54 (38%) | 50 (60%) | |
| Total | 141 (100%) | 83 (100%) | |
| Baseline Retinal Thickening at Center of Macula | 0.13 | ||
| None | 39 (28%) | 12 (14%) | |
| Questionable | 17 (12%) | 7 (8%) | |
| Definite, < 1X reference | 21 (15%) | 15 (18%) | |
| Definite, < 2X reference | 61 (43%) | 44 (53%) | |
| Definite, ≥ 2X reference | 3 (2%) | 5 (6%) | |
| Total | 141 (100%) | 83 (100%) | |
| Baseline Fluorescein Leakage Within Gridd | 0.30 | ||
| 0 – < 3DA | 85 (61%) | 20 (24%) | |
| ≥ 3DA | 55 (39%) | 63 (76%) | |
| Total | 140 (100%) | 83 (100%) | |
| Change in VAe, f | 0.01 | ||
| ≥ 10 letters better | 13 (14%) | 6 (9%) | |
| within ± 9 letters | 73 (77%) | 51 (77%) | |
| ≥ 10 letters worse | 9 (9%) | 9 (14%) | |
| Total | 95 (100%) | 66 (100%) | |
| Change in Fluorescein Leakage Within Gride | 0.29 | ||
| > 0.5 DA better | 58 (52%) | 47 (66%) | |
| within ± 0.5 DA | 40 (36%) | 11 (15%) | |
| > 0.5 DA worse | 13 (12%) | 13 (18%) | |
| Total | 111 (100%) | 71 (100%) | |
| Change in Central Subfield Thicknesse | 0.06 | ||
| > 40 microns better | 49 (44%) | 34 (48%) | |
| within ± 40 microns | 46 (41%) | 25 (35%) | |
| > 40 microns worse | 16 (14%) | 12 (17%) | |
| Total | 111 (100%) | 71 (100%) | |
| Change in DME Severity Scalee | 0.02 | ||
| ≥ 2 levels better | 32 (29%) | 22 (31%) | |
| within ± 1 levels | 56 (50%) | 41 (58%) | |
| ≥ 2 levels worse | 23 (21%) | 8 (11%) | |
| Total | 111 (100%) | 71 (100%) | |
a
Missing for 198 eyes (24 nongradable and 174 not assessed).
b
Excluded 12 eyes with ocular abnormalities other than DME that were considered a likely cause of decreased visual acuity.
c
Missing for 45 eyes.
d
Missing for 1 eye.
e
Missing for 62 eyes (17 nongradable and 45 not assessed).
f
Excluded 21 eyes with ocular abnormalities other than DME that were considered a likely cause of decreased visual acuity.
OCT=Optical Coherence Tomography, DME=Diabetic Macular Edema, DA=Disc Area, VA=Visual Acuity