Table 3. Secondary analyses by study arm—efficacy outcome measures at 12 months from baselinea.
| Fixed dosing | PRN dosing | ||
|---|---|---|---|
| BCVA (ETDRS letters) | No. of patients, n (%) (N) | No. of patients, n (%) (N) | Odds ratio |
| Improvement | |||
| ≥10 letters | 12 (24) (49) | 11 (23) (48) | 0.82 (0.3, 2.3) |
| ≥15 letters | 7 (14) (49) | 4 (8) (48) | 1.3 (0.33, 5.40) |
| ≥5 and<15 letters | 14 (29) (49) | 12 (25) (48) | 1.3 (0.50, 3.36) |
| Stabilization | |||
| <15 letters loss | 42 (86) (49) | 44 (92) (48) | 0.56 (0.15, 2.18) |
| No change | |||
| ≥−4 and ≤4 letters | 17 (35) (49) | 21 (44) (48) | 0.7 (0.3, 1.7) |
| Worsening | |||
| ≥5 and <15 letters | 4 (8) (49) | 7 (15) (48) | 0.65 (0.17, 2.60) |
| ≥15 letters | 7 (14) (49) | 4 (8) (48) | 1.76 (0.46, 6.76) |
| ETDRS grade of retinopathy | No. of patients, n (%) (N) | No. of patients, n (%) (N) | Odds ratio |
| Mild NPDR | 13 (28) (47) | 18 (40) (45) | — |
| Moderate NPDR | 16 (34) (47) | 16 (36) (45) | — |
| Severe NPDR | 6 (13) (47) | 4 (9) (45) | — |
| Treated PDR | 12 (25) (47) | 7 (15) (45) | — |
| PROM—composite score change | Mean (SD) (N) | Mean (SD) (N) | Effect estimate (95% CI) |
| NEI-VFQ-25 | 3.02 (15.4) (49) | −0.45 (12.2) (47) | 3.1 (−2.1, 8.3) |
| RetDQoL | −0.38 (1.7) (49) | −0.14 (1.6) (48) | −0.16 (−0.8, 0.5) |
| RetTSQ | 4.4 (12.7) (49) | 3.6 (15.1) (47) | 2.7 (−2.3, 7.7) |
| Central subfield thickness | Mean (SD) (N) | Mean (SD) (N) | Effect estimate (95% CI) |
| At 12 months | 292.9 (118.9) (47) | 372.3 (117.3) (47) | — |
| Change from baseline | −179.9 (172.4) (47) | −90.1 (96.2) (47) | −71.34 (−117.33, −25.34) |
| Treatment | Mean (SD)/median (IQR) (N) | Mean (SD)/median (IQR) (N) | Effect estimate (95% CI) |
| No. of injections per patient | 2.86 (0.45)/3 (3, 3) (50) | 2.60 (0.70)/3 (2, 3) (50) | 0.26 (0.03, 0.49) |
Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; ETDRS, Early Treatment Diabetic Retinopathy Study; IQR, interquartile range; n, number of patients; N, total number of patients; NEI-VFQ-25, National Eye Institute Visual Functioning Questionnaire; NPDR, non-proliferative diabetic retinopathy; PDR, proliferative diabetic retinopathy; PRN, pro-re-nata; PROM, patient-related outcome measures; RetDQoL, Retinopathy Dependent Quality of Life questionnaire; RetTSQ, Retinopathy Treatment Satisfaction Questionnaire.
a
Adjusted for baseline BCVA and study site.