Real-World Data on Intravitreal Aflibercept for Macular Edema Secondary to Central Retinal Vein Occlusion: 24-Month Outcomes

Figures & data

Figure 1 Flow of patients through the study.

Notes: ^aEnrolled patients who were confirmed to have been either previously treated with IVT-AFL or not according to the enrollment form. ^bIncludes one patient for whom no record of use of IVT-AFL was found on the CRF.

Abbreviations: BCVA, best corrected visual acuity; CRF, case report form; CRT, central retinal thickness.

Table 1 Patient Characteristics at Baseline

	Safety Analysis Set (n = 377)
Male, n (%)	193 (51.2)
Age, years
Mean ± SD	72.0 ± 11.6
Median (range)	73.0 (25–96)
Retinal perfusion status, n (%)
Non-ischemic	201 (53.3)
Ischemic	92 (24.4)
Unknown	84 (22.3)
Duration of disease at start of treatment, months
Median (range)	2.0 (0–144)
Duration of disease at start of treatment, months, n (%)
<2	95 (25.2)
≥2, <6	70 (18.6)
≥6, <12	20 (5.3)
≥12	33 (8.8)
Unknown	159 (42.2)
Best corrected visual acuity, logMAR [n = 370]
Mean ± SD	0.707 ± 0.538
Median (range)	0.523 (−0.08–2.00)
Best corrected visual acuity, decimal, n (%)
≤0.1 (logMAR 1.0)	130 (34.5)
0.1<, ≤0.5 (logMAR 0.3)	151 (40.1)
>0.5	89 (23.6)
Unknown	7 (1.9)
Central retinal thickness, μm [n = 217]
Mean ± SD	552.1 ± 210.2
Median (range)	537.0 (72–1,258)
Prior treatment, n (%)
No	236 (62.6)
Yes	134 (35.5)
Unknown	7 (1.9)
Medical history
Ocular	116 (30.8)
Non-ocular	79 (21.0)
Comorbidities, n (%)
Ocular	141 (37.4)
Cataract	102 (27.1)
Glaucoma	42 (11.1)
Conjunctivitis	6 (1.6)
Ocular hypertension	3 (0.8)
Uveitis	2 (0.5)
Other	16 (4.2)
Non-ocular	207 (54.9)
Hypertension	157 (41.6)
Diabetes mellitus	46 (12.2)
Hyperlipidemia	45 (11.9)
Renal impairment	9 (2.4)
Impaired liver function	6 (1.6)
Old cerebral infarction	5 (1.3)
Angina pectoris	5 (1.3)
Old myocardial infarction	4 (1.1)
Other	45 (11.9)

Abbreviation: SD, standard deviation.

Table 2 Incidence of Adverse Events

	Patients, n (%)
	All Adverse Events	Serious Adverse Events
Safety analysis set	377 (100)	377 (100)
Any adverse event	22 (5.84)^a	12 (3.18)^a
Infections and infestations	1 (0.27)	1 (0.27)
Pneumonia bacterial	1 (0.27)	1 (0.27)
Neoplasms, benign, malignant, and unspecified (including cysts and polyps)	1 (0.27)	1 (0.27)
Mesothelioma malignant	1 (0.27)	1 (0.27)
Nervous system disorders	1 (0.27)	1 (0.27)
Facial paralysis	1 (0.27)	1 (0.27)
Eye disorders	11 (2.92)^a	5 (1.33)
Retinal vein occlusion	2 (0.53)^b	2 (0.53)^b
Glaucoma	2 (0.53)	1 (0.27)^c
Ocular hypertension	2 (0.53)	0
Cataract	1 (0.27)	1 (0.27)
Malignant glaucoma	1 (0.27)	1 (0.27)
Conjunctivitis allergic	1 (0.27)	0
Corneal infiltrates	1 (0.27)	0
Posterior capsule opacification	1 (0.27)	0
Retinal hemorrhage	1 (0.27)	0
Vitreous hemorrhage	1 (0.27)	0
Cardiac disorders	2 (0.53)	2 (0.53)
Cardiac failure	1 (0.27)	1 (0.27)
Myocardial infarction	1 (0.27)^d	1 (0.27)^d
Congenital, familial and genetic disorders	1 (0.27)	1 (0.27)
Familial amyloidosis	1 (0.27)	1 (0.27)
General disorders and administration site conditions	1 (0.27)	1 (0.27)
Death	1 (0.27)	1 (0.27)
Investigations	5 (1.33)	0
Intraocular pressure increased	4 (1.06)	0
Intraocular pressure decreased	1 (0.27)	0
Surgical and medical procedures	2 (0.53)	1 (0.27)
Cataract operation	1 (0.27)	1 (0.27)
Retinal laser coagulation	1 (0.27)	0

Notes: ^aIncluding patients with multiple adverse events. ^bWorsened ischemic CRVO in one patient and development of CRVO in the fellow eye in another patient. ^cNeovascular glaucoma. ^dHistory of myocardial infarction.

Table 3 Safety Specifications: Incidence of Serious and Non-Serious Adverse Events

Safety Analysis Set (n = 377)	Adverse Events
	Serious	Non-Serious
	Patients, n (%)	Patients, n (%)
Important risks identified
Inflammatory intraocular response	0	0
Increased intraocular pressure	0	6 (1.6)
Retinal tear and retinal detachment	0	0
Traumatic cataract	0	0
Important potential risk
Arterial thromboembolic events	1 (0.3)	0

Notes: MedDRA terms for each type of event are listed in Supplementary Table 1.

Figure 2 BCVA and CRT across 24 months. (A) LogMAR BCVA and number of patients across 24 months. (B) CRT (μm) and number of patients across 24 months. Markers and whiskers show the mean and standard deviation of BCVA and CRT, respectively.

Abbreviations: BCVA, best corrected visual acuity; BL, baseline; CRT, central retinal thickness; logMAR, logarithm of the minimum angle of resolution.

Figure 3 Subgroup analysis based on presence or absence of prior treatment. (A) LogMAR BCVA and number of patients across 24 months. (B) CRT (μm) and number of patients across 24 months. Markers and whiskers show the mean and standard deviation of BCVA and CRT, respectively.

Abbreviations: BCVA, best corrected visual acuity; BL, baseline; CRT, central retinal thickness; logMAR, logarithm of the minimum angle of resolution.

Figure 4 Subgroup analysis based on baseline decimal BCVA. (A) LogMAR BCVA and number of patients across 24 months. (B) CRT (μm) and number of patients across 24 months. Markers and whiskers show the mean and standard deviation of BCVA and CRT, respectively.

Abbreviations: BCVA, best corrected visual acuity; BL, baseline; CRT, central retinal thickness; logMAR, logarithm of the minimum angle of resolution.