Efficacy and Safety of an Aflibercept Treat-and-Extend Regimen in Treatment-Naïve Patients with Macular Oedema Secondary to Central Retinal Vein Occlusion (CRVO): A Prospective 12-Month, Single-Arm, Multicentre Trial
Table 2
BCVA and secondary endpoints after loading doses (month 3), at end of trial (month 12), and aflibercept exposure.
ITT population ()
value
BCVA score (ETDRS letters)
Week 0 (baseline),
24
Mean (SD) score
56.0 (16.5)
Month 3,
21
Mean (SD) score
70.8 (19.6)
95% CI
61.9, 79.7
Mean (95% CI) change from baseline
14.0 (7.8, 20.2)
0.0001
Month 12 (EOT),
21
Mean (SD) score
74.1 (17.6)
95% CI
66.1, 82.1
Mean (95% CI) change from baseline
14.8 (8.2, 21.4)
0.0001
Proportion gaining ≥15 ETDRS letters at EOT, (%)
Yes
12 (50.0)
No
9 (37.5)
Not available
3 (12.5)
Retinal (foveal) thickness by SD-OCT (μm)
Week 0 (baseline),
24
Mean (SD) score
569.4 (216.8)
Month 3,
21
Mean (SD) score
291.9 (151.2)
95% CI
223.1, 360.7
Mean (95% CI) change from baseline
−272.2 (−377.4, −167.0)
<0.0001
Month 12 (EOT),
21
Mean (SD) score
257.4 (48.4)
95% CI
235.4, 279.5
Mean (SD) change from baseline
−296.0 (−395.1, −196.8)
<0.0001
Proportion with MO (SD-OCT), (%)
Week 0 (baseline),
24
Yes
24 (100.0)
Month 3,
21
Yes
2 (8.3)
No
19 (79.2)
Month 12 (EOT),
21
Yes
2 (8.3)
No
19 (79.2)
Exposure: number of aflibercept injections
Number of injections
Mean (SD)
8.3 (3.0)
Median (IQR)
8.0 (8.0, 10.5)
TAE injection interval (weeks)
Mean (SD)
7.0 (2.2)
Median (IQR)
6.1 (5.2, 9.1)
BCVA: best-corrected visual acuity; ETDRS: early treatment diabetic retinopathy study; EOT: end of trial; IQR: interquartile range; ITT: intention-to-treat; MO: macular oedema; SD: standard deviation; SD-OCT: spectral-domain optical coherence tomography. TAE: treat-and-extend. All values compared to baseline using Student’s t-test for paired samples.
