Journal of Ophthalmology / 2018 / Article / Tab 2

Clinical Study

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) score56.0 (16.5)
Month 3, 21
 Mean (SD) score70.8 (19.6)
 95% CI61.9, 79.7
 Mean (95% CI) change from baseline14.0 (7.8, 20.2)0.0001
Month 12 (EOT), 21
 Mean (SD) score74.1 (17.6)
 95% CI66.1, 82.1
 Mean (95% CI) change from baseline14.8 (8.2, 21.4)0.0001

Proportion gaining ≥15 ETDRS letters at EOT, (%)
Yes12 (50.0)
No9 (37.5)
Not available3 (12.5)

Retinal (foveal) thickness by SD-OCT (μm)
Week 0 (baseline), 24
 Mean (SD) score569.4 (216.8)
Month 3, 21
 Mean (SD) score291.9 (151.2)
 95% CI223.1, 360.7
 Mean (95% CI) change from baseline−272.2 (−377.4, −167.0)<0.0001
Month 12 (EOT), 21
 Mean (SD) score257.4 (48.4)
 95% CI235.4, 279.5
 Mean (SD) change from baseline−296.0 (−395.1, −196.8)<0.0001

Proportion with MO (SD-OCT), (%)
Week 0 (baseline), 24
 Yes24 (100.0)
Month 3, 21
 Yes2 (8.3)
 No19 (79.2)
Month 12 (EOT), 21
 Yes2 (8.3)
 No19 (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.

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