
Diagram 1: CONSORT 2010 Flow diagram describing randomizing process and follow-up
Characteristicst |
SMLP + curcumin-based drug (N tot: 9) |
Only SMLP (N. tot: 15) |
Sex Male Female |
-5 (55%) |
-8 (53%) |
Age (mean), years |
65 (55-71) |
63 (56-74) |
Laterality Right eye Left eye |
5 (55%) |
-8 (53%) |
Durationofdiabetes(mean), years |
11 (8-14) |
12 (9-14) |
Insulin used |
4 (45%) |
7 (47%) |
Last HbA1c measurement before enrolling (mean), % |
7,1 % (6,8% - 7,4%) |
7,2% (6,9% - 7,5%) |
Best Corrected Visual Acu-ity (mean) |
6/10 (4/10- 8/10) |
5/10 (4/10 – 7/10) |
Central macular thickness (μm) |
- 5 (55%) |
- 9 (60%) |
" Prior treatment for DME |
- 4 (44%) |
- 7 (47%) |
Table 1: Baseline Patients and Ocular characteristics
|
"ctrl" |
"ivt" |
"p" |
"CMT at time zero, baseline (mean (SD))" |
396.67 (73.21) |
414.13 (48.82) |
0.489 |
"CMT at time zero, baseline (median [IQR])" |
410.00 [395.00, 430.00] |
425.00 [391.00, 444.50] |
0.531 |
"month4 (mean (SD))" |
404.88 (24.99) |
345.38 (56.16) |
0.011 |
"month4.imp (mean (SD))" |
384.44 (65.60) |
355.67 (58.65) |
0.277 |
"month4 (median [IQR])" |
400.00 [395.00, 419.25] |
370.00 [307.00, 386.00] |
0.008 |
"month4.imp (median [IQR])" |
400.00 [380.00, 419.00] |
372.00 [320.50, 395.00] |
0.169 |
Table 2: Univariate analyses for relevant variables. The statistical analyses explored differences between control (ctrl) and treated patients (ivt). In this table, the measures obtained at month four were reported with missing values (month) or as imputed variables (month4.imp) where missing data were replaced using Last Observation Carried Forward (LOCF) method using values from time zero (baseline) to gener- ate the new variable moonth4.imp, in order to create a new set of measurements imputed.
|
"ctrl" |
"ivt" |
"p" |
"month6 (mean (SD))" |
373.33 (30.55) |
320.40 (72.69) |
0.255 |
"month6.imp (mean (SD))" |
395.00 (32.95) |
327.77 (64.91) |
0.014 |
"month6 (median [IQR])" |
380.00 [360.00, 390.00] |
312.00 [277.50, 363.50] |
0.176 |
"month6.imp (median [IQR])" |
400.00 [377.50, 405.00] |
334.00 [300.00, 368.00] |
0.007 |
Table 3: Univariate analyses for relevant variables at six months. In this table, the measures obtained at month 6 were reported with missing value (month6) or as imputed variables (month6.imp) where missing data were replaced using Last Observation Carried Forward (LOCF) method using values from month4 to generate the new variable moonth6.imp, in order to create a new set of measurements imputed.
Diagram 1: CONSORT 2010 Flow diagram describing randomizing process and follow-up
Figure 1 and Figure 2: CMT standard deviation over follow-up period; ctrl=control group; ivt=treated group
Figure 3: Mean standard deviation of central macular thickness at time 0, time 4 months and time 6 months
Figure 4: OCT overview report of a patient in the ivt (treatment) group: in the upper part at tima 0, in the lower part at time 6 months after treatment
Tables at a glance
Figures at a glance