Real-World Outcomes of Intravitreal Aflibercept for Neovascular Age-Related Macular Degeneration: A Large-Scale Postmarketing Surveillance in Korea

Figures & data

Figure 1 Distribution of patients included in the study.

Abbreviations: BCVA, best-corrected visual acuity; CRF, case report form; CRT, central retinal thickness; LOCF, last observation carried forward; nAMD, neovascular age-related macular degeneration.

Table 1 Baseline Patient Demographics and Disease Characteristics

Variable	Total (n=3115)
Age (years)	70.0±8.9
Age Group, n (%)
<50 years	21 (0.7)
50–59 years	398 (12.8)
60–69 years	1052 (33.8)
70–79 years	1182 (38.0)
≥80 years	462 (14.8)
Sex, n (%)
Male	1925 (61.8)
Female	1190 (38.2)
Baseline BCVA, logMAR	0.62±0.40
Duration of nAMD, days (median; Q1, Q3)	16.3±119.9 (1.0; 1.0, 6.0)
Duration Category^a, n (%)
<1 month	2266 (96.3)
1 – <3 months	41 (1.7)
≥3 months	46 (2.0)
Pretreatment of nAMD, n (%)	21 (0.7)
PDT	2 (9.5)
Photocoagulation	4 (19.1)
Surgery	2 (9.5)
Other anti-VEGF agents	13 (61.9)
Subtype of nAMD, n (%)
PCV	825 (26.5)
Non-PCV	1529 (49.1)
Occult CNV	622 (40.7)
Predominantly classic CNV	604 (39.5)
Minimally classic CNV	189 (12.4)
RAP	100 (6.5)
Other	14 (0.9)
Unknown	761 (24.4)

Notes: Values are mean±standard deviation unless otherwise noted. ^aA total of 762 patients were excluded for analysis of duration.

Abbreviations: BCVA, best-corrected visual acuity; CNV, choroidal neovascularization; logMAR, logarithm of the minimum angle of resolution; nAMD, neovascular age-related macular degeneration; PCV, polypoidal choroidal vasculopathy; PDT, photodynamic therapy; RAP, retinal angiomatous proliferation; VEGF, vascular endothelial growth factor.

Table 2 Treatment Exposure Over 8 Months

Variables	Total (n=3115)
Mean number of injections	3.4±1.0
Patients with 1 to 5 Injections, n (%)
1 injection	215 (6.9)
2 injections	518 (16.6)
3 injections	1376 (44.2)
4 injections	596 (19.1)
5 injections	410 (13.2)
Mean number of visits	4.5±1.5
Patients with 1 to 6 Visits, n (%)
1 visit	66 (2.1)
2 visits	277 (8.9)
3 visits	586 (18.8)
4 visits	540 (17.3)
5 visits	491 (15.8)
6 visits	1155 (37.1)

Note: Values are mean±standard deviation unless otherwise noted.

Figure 2 BCVA and CRT over 8 months. (A) BCVA (logMAR), (B) CRT (µm).

Abbreviations: BCVA, best-corrected visual acuity; CRT, central retinal thickness; LOCF, last observation carried forward; logMAR, logarithm of minimum angle resolution.

Figure 3 Proportion of patients with vision outcome (3 categories) compared to baseline.

Abbreviations: LOCF, last observation carried forward; logMAR, logarithm of minimum angle resolution.

Figure 4 Mean change of BCVA and CRT depending on initial monthly dosing status (whether patients received three initial injections given at intervals of 1 month ± 14 days). (A) Mean change of BCVA depending on initial monthly dosing status. (B) The mean change of CRT depending on the initial monthly dosing status. *P < 0.05.

Abbreviations: BCVA, best-corrected visual acuity; CRT, central retinal thickness; LOCF, last observation carried forward; logMAR, logarithm of minimum angle resolution.

Figure 5 Mean change of BCVA and CRT depending on subtypes of nAMD. (A) The mean change of BCVA depending on subtypes of nAMD (PCV vs non-PCV). (B) the mean change of CRT depending on subtypes of nAMD (PCV vs non-PCV). *P < 0.001, **P < 0.05.

Abbreviations: BCVA, best-corrected visual acuity; CRT, central retinal thickness; LOCF, last observation carried forward; logMAR, logarithm of minimum angle resolution.

Table 3 Multivariate Regression Analysis Associated with BCVA and CRT Outcome at 8 Months

Variables	3-Line Gainers		CRT ≤ 250 µm
	P-value	OR (95% CI)	P-value	OR (95% CI)
Age, years	<0.001	0.97 (0.96, 0.98)	0.057	1.01 (1.00, 1.02)
Sex, male vs female	0.647	1.05 (0.86, 1.27)	0.027	0.83 (0.71, 0.98)
Number of injections	<0.001	1.56 (1.45, 1.68)	<0.001	1.43 (1.35, 1.51)
Subtype of nAMD (patients with vs without confirmed PCV)	0.001	1.44 (1.16, 1.78)	0.007	1.28 (1.07, 1.53)
Baseline CRT, µm	0.385	1.00 (1.00, 1.00)	<0.001	0.99 (0.99, 0.99)
Baseline BCVA, logMAR^a
First Quartile
Second quartile	<0.001	15.58 (8.68, 27.96)	0.100	0.84 (0.68, 1.04)
Third quartile	<0.001	41.44 (23.27, 73.81)	0.717	1.04 (0.84, 1.29)
Fourth quartile	<0.001	98.00 (54.56, 176.03)	0.236	1.16 (0.91, 1.47)

Notes: ^aBaseline BCVA was classified through quartiles: first quartile −0.079 ≤ BCVA (logMAR) ≤ 0.301; second quartile 0.301 < BCVA (logMAR) ≤ 0.523; third quartile 0.523 < BCVA (logMAR) ≤ 0.824; fourth quartile 0.824 < BCVA (logMAR) ≤ 2.000.

Abbreviations: BCVA, best-corrected visual acuity; CI, confidence interval; CRT, central retinal thickness; nAMD, neovascular age-related macular degeneration; OR, odds ratio; PCV, polypoidal choroidal vasculopathy.