Impact of Different Clinical Baseline Characteristics on Intravitreal Dexamethasone Implant Ozurdex^® Outcomes

Figures & data

Table 1 Baseline Demographic and Clinical Characteristics of the Study Sample

Number
Subjects	65
Eyes	97
Age, years
Mean (SD)	67.1 (9.9)
Range	37 to 85
Sex, n (%)*
Male	33 (50.8)
Female	32 (49.2)
BCVA, letters^†
Mean (SD)	64.7 (11.5)
CMT, µm
Mean (SD)	458.0 (120.0)
IOP, mm Hg
Mean (SD)	16.5 (2.9)
PUAM, n (%)	0 (0.0)
HbA1c, %*
Mean (SD)	8.2 (1.1)
Duration of DM, years
Mean (SD)	14.2 (9.5)
Duration of DME, months
Mean (SD)	12.6 (16.8)
Previous treatment, n (%)**
None	67 (69.1)
Focal/grid Laser	58 (59.8)
Anti-VEGF	34 (35.1)
IVC	0 (0.0)
DME perfusion status
Ischemic	76 /78.4)
Non-ischemic	21 (21.6)
Lens status, n (%)
Phakic	48 (49.5)
Pseudophakic	49 (50.5)

Notes: *Based on number of subjects. **Eyes could undergo multiple treatment types. ^†Letters in the Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Abbreviations: SD, standard deviation; BCVA, best corrected visual acuity; CMT, central macular thickness; IOP, intraocular pressure; PUAM, Patients using antiglaucoma medication; DM, Diabetes Mellitus; DME, diabetic macular edema; VEGF, vascular endothelial growth factor; IVC, intravitreal corticosteroids.

Figure 1 Mean best corrected visual acuity (BCVA) [Early Treatment Diabetic Retinopathy Study (ETDRS) charts] at baseline and at the end of the study. *Statistical significance was determined using the two-way paired Student’s t-test.

Figure 2 Mean central macular thickness (CMT) at baseline and at the end of the study. *Statistical significance was determined using the two-way paired Student’s t-test.

Table 2 Main Clinical Outcomes

Number
Eyes	97
Implants	192
DEX with BCVA improvement ≥ 15 letters*, n (%)	57 (29.7)
Time for achieving such improvement, days
Mean (SD)	82.9 (37.9)
DEX with BCVA improvement ≥ 10 letters, n (%)	84 (43.8)
Time for achieving such improvement, days
Mean (SD)	93.6 (38.2)
DEX with BCVA reduction ≥ 15 letters, n (%)	24 (12.5)
Time for achieving such reduction, days
Mean (SD)	101.0 (41.6)
DEX with BCVA reduction ≥ 10 letters, n (%)	31 (16.1)
Time for achieving such reduction, days
Mean (SD)	101.0 (42.7)
Change in BCVA, letters
Mean (SD)	7.5 (14.5)
Time for achieving peak improvement, days
Mean (SD)	97.9 (41.1)
Change in CMT, µm
Mean (SD)	−128.0 (151.0)
Time for achieving peak improvement, days
Mean (SD)	99.6 (41.4)
Number of DEX
Mean (SD)	1.8 (0.9)
Duration of the study, years
Mean (SD)	2.1 (1.0)

Notes: *Letters in the Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

Abbreviations: DEX, intravitreal dexamethasone implant; BCVA, best corrected visual acuity; SD, standard deviation; CMT, central macular thickness.

Figure 3 A comparison of baseline best corrected visual acuity among the different groups. P values were calculated by using the two-way independent sample Student t-test.

Abbreviations: DME, diabetic macular edema; Prev Tto, previously treated; DEX, intravitreal dexamethasone implant.

Table 3 Impact of Different Study Variables on Achieving an Improvement in BCVA ≥ 15 Letters

Variables	n	Achieved, %	OR (95 CI)	P value
Lens status
Phakic*	94	24.5	1.64 (0.88 to 3.07)	0.1225
Pseudophakic	98	34.7
DME perfusion status
No*	150	30.7	0.85 (0.41 to 1.79)	0.6766
Yes	42	26.2
DME status
Naïve*	129	33.3	0.67 (0.34 to 1.31)	0.2385
Previously treated	63	22.2
Duration of DME
<6 months	103	35.9	1.93 (1.02 to 3.67)	0.0434
≥6 months*	85	23.5
HbA1c
≤8%*	83	32.5	0.93 (0.51 to 1.69)	0.8156
>8%	99	30.3
DEX
First*	97	18.6	2.55 (1.38 to 4.72)	0.0028
Subsequents	95	36.9

Note: *Reference group. P-values were considered statistically significant at <0.05.

Abbreviations: n, Number; OR, Odds ratio; CI, confidence interval; DME, diabetic macular edema; DEX, intravitreal dexamethasone implant.

Table 4 Impact of Different Study Variables on Achieving an Improvement in BCVA ≥ 10 Letters

Variables	n	Achieved, %	OR (95 CI)	P value
Lens status
Phakic*	94	39.4	1.42 (0.80 to 2.52)	0.2306
Pseudophakic	98	48.0
DME perfusion status
Non-ischemia	150	45.3	1.35 (0.67 to 1.50)	0.4042
Ischemia*	42	38.1
DME status
Naïve	129	48.8	2.0 (1.07 to 3.73)	0.0295
Previously treated*	63	33.3
Duration of DME
<6 months	103	53.4	2.37 (1.32 to 4.27)	0.0040
≥6 months*	85	34.1
HbA1c
≤8%*	83	45.8	0.95 (0.53 to 1.70)	0.8565
>8%	99	44.4
DEX
First*	97	34.0	3.04 (1.69 to 5.48)	0.0002
Subsequents	95	47.5

Notes: *Reference group. P-values were considered statistically significant at <0.05.

Abbreviations: n, Number; OR, Odds ratio; CI, confidence interval; DME, diabetic macular edema; DEX, intravitreal dexamethasone implant.

Table 5 Overview of the Incidence of Adverse Events Over the Course of the Study Follow-Up

Adverse Events (AEs)	All Injections
	Eyes=97
	Injections=192
IOP ≥ 25mm Hg, n (%)	3 (1.6)
Increase of 10 mmHg from baseline, n (%)	4 (2.1)
Use of IOP lowering medication, n (%)	2 (7.1)
Cataract, n (%)	7 (100)
Other related AEs, n (%)	5 (62.5)