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. Author manuscript; available in PMC: 2014 Aug 25.
Published in final edited form as: JAMA Ophthalmol. 2013 Jul;131(7):870–879. doi: 10.1001/jamaophthalmol.2013.2313

Table 6.

Secondary Outcomes at 16-Week Visit

Overall Did not Develop
Central-Involved
Macular Edema
Developed
Central-Involved
Macular Edema
Visual Acuity N = 279 N = 246 * N = 30 *
 Baseline visual acuity- E-ETDRS Letter
 score Mean±STD (Median)
66±15 (69) 67±15 (70) 60±15 (63)
 Baseline visual acuity- Snellen Equivalent
 Mean
20/50 20/50 20/63
 Proportion Letter score ≥69 (20/40) at
 baseline – N (%)
144 (52%) 134 (54%) 10 (33%)
16-week Outcomes
  VA- Mean±STD (Median) 78±12 (81) 80±11 (82) 69 ± 12 (72)
  Snellen Equivalent – Mean (Median) 20/32 (20/25) 20/25 (20/25) 20/40 (20/40)
  E-ETDRS Letters Change at 16-week-
   Mean ± STD (Median)
+12±14 (+10) +13 ±14 (+11) + 9±14 (+5)
  Distribution at 16-week - N (%)
  Proportion letter score ≥69 (20/40) 241 (86%) 219 (89%) 20 (67%)
  Proportion with ≥10 Letter Gain 148 (53%) 135 (55%) 11 (37%)
  Proportion with ≥20 Letter Gain 66 (24%) 58 (24%) 6 (20%)
  Proportion with ≥10 Letter Loss 11 (4%) 7 (3%) 3 (10%)
  Proportion with ≥20 Letter Loss 1 (<1%) 0 (0%) 0 (0%)
OCT From Time Domain Machine N=261 N=233 N=28
 Baseline CSF μm-Median (25th , 75th
 Percentile)
202 (182, 220) 201 (181, 218) 204 (191, 235)
 CSF Thickness (μm) at 16 weeks-Median
 (25th, 75th Percentile)
210 (192, 237) 208 (190, 231) 297 (254, 357)
 CSF Thickness (μm) at 16 weeks (if DME
treatment was given, last value before
treatment carried to 16 weeks)- Median
(25th, 75th Percentile)
212 (193, 241) 208 (190, 231) 309 (283,422)
 CSF Thickness Change (μm) from Baseline
at 16 weeks - Median (25th , 75th Percentile)
+9 (+1, +27) +8 (0, +19) +89 (+63, +133)
 CSF Thickness Change (μm) from Baseline
 (16 weeks value obtained from last
 observation before DME treatment given)
 Median (25th , 75th Percentile)
+10 (+1, +28) +8 (0, +19) +104 (+81, +196)
 Relative CSF Thickness Change from
 Baseline- % Median (25th, 75th Percentile)
+5% (0%, +14%) +4% (0%, +9%) +41% (+30%,
+67%)
 Proportion with CSF Thickness >250 and
 increased at least 25μm- N (%)
35 (13%) 13 (6%) 22 (79%)¦
 Total Volume mm3- Median (25th, 75th
 percentile)
7.0 (6.5, 7.5) 6.9 (6.5, 7.4) 7.8 (7.2,8.6)
 Total Volume mm3 change from baseline-
 Median (25th, 75th percentile)
+0.3 (+0.1, +0.6) +0.2 (+0.1, +0.5) +1.2 (+0.4, +1.6)
Diabetic Retinopathy Progression From
Baseline§ – N (%)
 ≥2 Step Worsening 2 (1%) 1 (<1%) 1 (3%)
 1 Step Worsening 25 (9%) 22 (9%) 3 (10%)
 No Change 229 (82%) 202 (82%) 24 (80%)
 1 Step Improvement 25 (9%) 22 (9%) 3 (10%)
 ≥2 Step Improvement 2 (1%) 1 (<1%) 1 (3%)

E-ETDRS= Electronic early treatment diabetic retinopathy study; STD=standard deviation; OCT=optical coherence tomography; CSF=central subfield; DME=diabetic macular edema;

*

Outcome could not be calculated for 3 eyes with non-gradable or missing OCT at baseline or 16-week visit.

Seven eyes that had baseline and 16-week OCT obtained by different time and spectral domain machines were excluded.

¦

For eyes receiving DME treatment, last CSF thickness before treatment is used.

Missing in 8, 5, and 3 for the overall, did not, and did develop central involved macular edema cohorts respectively.

Missing in 25, 19, and 6 for the overall, did not, and did develop central involved macular edema cohorts respectively

§

By clinical exam. Scale: none, microaneurysms only, mild/moderate non- proliferative diabetic retinopathy, severe non- proliferative diabetic retinopathy and proliferative diabetic retinopathy.