Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea

Figures & data

Figure 1 Subject flow diagram for post-hoc analysis of post-marketing surveillance (PMS) study of dexamethasone intravitreal implant use in patients with branch retinal vein or central retinal vein occlusion.

Table 1 Baseline Characteristics and Demographics of Patients Included in the Post-Hoc Analysis

Variables	Total (n = 700)	BRVO (n = 554)	CRVO (n = 146)	P value^a
Age (years), mean (SD)	62.5 (10.9)	62.6 (10.3)	62.0 (13.1)	0.606
Age groups, n (%)
<40	11 (1.6)	5 (0.9)	6 (4.11)	1.00
40–49	60 (8.6)	43 (7.8)	17 (11.6)
50–59	228 (32.6)	185 (33.4)	43 (29.5)
60–69	206 (29.4)	172 (31.1)	34 (23.3)
70–79	154 (22.0)	120 (21.7)	34 (23.3)
≥80	41 (5.9)	29 (5.2)	12 (8.2)
Sex, n (%)				0.219
Female	412 (58.9)	333 (60.1)	79 (54.1)
Male	288 (41.1)	221 (39.9)	67 (45.9)
Treated eye, n (%)				1.000
Left	356 (50.9)	282 (50.9)	74 (50.7)
Right	344 (49.1)	272 (49.1)	72 (49.3)
Baseline BCVA (LogMAR), mean (SD)	0.68 (0.39)	0.67 (0.38)	0.76 (0.42)	0.013
BCVA group, n (%)				0.006
<20/320	82 (11.7)	57 (10.6)	25 (20.3)
20/320-20/100	241 (34.4)	191 (35.6)	50 (40.7)
20/100-20/40	289 (41.3)	249 (46.4)	40 (32.5)
>20/40	48 (6.9)	40 (7.5)	8 (6.5)
Treatment history for macular edema				0.707
Yes	400 (57.1)	319 (57.6)	81 (55.5)
Details of treatment (overlapped)
Laser photocoagulation	93 (23.3)	81 (25.4)	12 (14.8)	0.055
Vitreous surgery	14 (3.5)	11 (3.4)	3 (3.7)	1.000
Intravitreal steroid injection	86 (21.5)	67 (21.0)	19 (23.5)	0.651
PDT	0	0	0
Other (ie, anti-VEGF agents)	332 (83.0)	264 (82.8)	68 (84.0)	0.870
No	300 (42.9)	235 (42.4)	65 (44.5)

Notes: ^aFor summaries of means, t-test; for categorical summaries, two-tailed Fisher’s exact test; BRVO vs CRVO. Age categories ≤65 and >65.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; LogMAR, Logarithm of the Minimum Angle of Resolution; PDT, photodynamic therapy; SD, standard deviation; VEGF, vascular endothelial growth factor.

Table 2 Number and Timing of DEX Implant Treatments

Parameter	Total Population (n = 700)	BRVO (n = 554)	CRVO (n = 146)
Number of DEX implant injections, n (%)
≥1	700	554	146
≥2	70	50	20
≥3	10	8	2
≥4	3	2	1
For patients who received second injection (n= 70 total):
Mean (SD) days from first to second injection	101.6 (63.4)	90.2 (66.1)	130.0 (46.3)
For patients who received third injection (n= 10 total):
Mean (SD) days from first to third injection	157.6 (90.9)	145.1 (79.4)	207.5 (154.9)
Mean (SD) days from second to third injection	91.8 (69.4)	90.9 (76.7)	95.5 (46.0)

Abbreviations: BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; DEX implant, dexamethasone intravitreal implant; SD, standard deviation.

Table 3 Mean BCVA in Specified Analysis Windows^a

Analysis Window^a	Mean LogMAR (SD)
	Total Population (n = 700)	BRVO (n = 554)	CRVO (n = 146)
Baseline (n = 660)	0.683 (0.392)	0.665 (0.383)	0.762 (0.421)
Month 1 (n = 569)	0.526 (0.378)	0.507 (0.367)	0.604 (0.412)
Month 2 (n = 313)	0.511 (0.365)	0.491 (0.356)	0.581 (0.392)
Month 4 (n = 363)	0.554 (0.382)	0.542 (0.378)	0.599 (0.397)
Month 6 (n = 104)	0.566 (0.394)	0.556 (0.397)	0.645 (0.383)

Notes: ^aAnalysis windows were defined as month 1: days 1–45; month 2: days 46–90; month 4: days 91–150; month 6: days ≥ 151. For each analysis window, patients’ visits closest to the target day were included in the analysis.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; LogMAR, Logarithm of the Minimum Angle of Resolution; SD, standard deviation.

Figure 2 (A) Mean best-corrected visual acuity and (B) mean change in best-corrected visual acuity from baseline in patients with BRVO or CRVO.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; approxETDRS, approximate Early Treatment Diabetic Retinopathy Study; LogMAR, Logarithm of the Minimum Angle of Resolution; (n), number of patients.

Figure 3 Mean change in best-corrected visual acuity from baseline in (A) BRVO patients and (B) CRVO patients by treatment naivety.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; approxETDRS, approximate Early Treatment Diabetic Retinopathy Study; LogMAR, Logarithm of the Minimum Angle of Resolution; (n), number of patients.

Figure 4 Improvements in best-corrected visual acuity of (A) ≥0 line, (B) ≥1 line, (C) ≥2 line, and (D) ≥3 line from baseline within each analysis window.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; (n), number of patients.

Figure 5 Distribution of best-corrected visual acuity of (A) ≥1 line, (B) ≥2 line, or (C) ≥3 line decreases from baseline within each analysis window.

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; (n), number of patients.

Table 4 Logistic Regression Analysis of Potential Associations with Line Improvement in BCVA in the Month 2 Analysis Windows

Parameter	Logistic Regression (Month 2 Analysis Window)
	≥1-Line Improvement			≥2-Line Improvement			≥3-Line Improvement
	OR	95% CI	P-value	OR	95% CI	P-value	OR	95% CI	P-value
Month 2 Analysis Window
Diagnosis (BRVO versus CRVO)	1.048	0.566–1.941	0.881	1.102	0.596–2.041	0.756	1.012	0.522–1.962	0.972
Treatment naivety (naïve versus non-naïve)	1.783	1.069–2.974	0.027	2.033	1.229–3.365	0.006	2.793	1.620–4.816	<0.001
Age	0.970	0.946–0.994	0.015	0.970	0.947–0.994	0.014	0.962	0.937–0.988	0.004
Baseline LogMAR BCVA	7.650	3.410–17.163	<0.0001	9.528	4.414–20.568	<0.0001	18.090	7.749–42.232	<0.0001

Abbreviations: BCVA, best-corrected visual acuity; BRVO, branch retinal vein occlusion; CI, confidence interval; CRVO, central retinal vein occlusion; LogMAR, Logarithm of the Minimum Angle of Resolution; OR, odds ratio.

Table 5 Summary of Ocular and Systemic AEs, All Eyes

Event, n (%)	Total (n= 700)	BRVO (n= 554)	CRVO (n= 146)
IOP elevation	37 (5.3)	26 (4.7)	11 (7.5)
Allergic conjunctivitis	2 (0.3)	1 (0.2)	1 (0.7)
Endophthalmitis	2 (0.3)	2 (0.4)	0
Eye discomfort	2 (0.3)	1 (0.2)	1 (0.7)
Eye pain	2 (0.3)	2 (0.4)	0
Subconjunctival hemorrhage	2 (0.3)	1 (0.2)	1 (0.7)
Cataract	1 (0.1)	0	1 (0.7)
Central chorioretinopathy	1 (0.1)	1 (0.2)	0
Conjunctival induration	1 (0.1)	1 (0.2)	0
Dizziness	1 (0.1)	0	1 (0.7)
Eye hemorrhage	1 (0.1)	1 (0.2)	0
Eye pingeculitis suspect	1 (0.1)	0	1 (0.7)
Macular hole	1 (0.1)	1 (0.2)	0
Eye redness	1 (0.1)	1 (0.2)	0
Total patients, n (%)	53 (7.6)	36 (6.5)	17 (11.6)

Abbreviations: AE, adverse event; BRVO, branch retinal vein occlusion; CRVO, central retinal vein occlusion; IOP, intraocular pressure.