Efficacy and safety of sustained-delivery fluocinolone acetonide intravitreal implant in patients with chronic diabetic macular edema insufficiently responsive to available therapies: a real-life study

Figures & data

Table 1 Demographics and baseline characteristics of study patients and eyes

Characteristics	Group 1, prior laser only	Group 2, prior laser and anti-VEGF
Patients, n	6	10
Age, years, median (range)	67 (55–81)	64 (39–75)
Male sex, n (%)	4 (66)	5 (50)
Type 2 diabetes, n (%)	5 (83)	7 (70)
HbA1c, %, mean (SD)	8.2 (1.2)	8.1 (1.6)
Eyes, n	7	10
Right study eye, n (%)	4 (57)	6 (60)
Pseudophakic lens status, n (%)	7 (100)	5 (50)
Duration of DME, years, median (range)	7.6 (3.2–11.6)	3.6 (0.9–9.7)
Prior intravitreal corticosteroid, n (%)	6 (86)	8 (80)
BCVA, mean (SD), letters	47.7 (10.1)	44.8 (12.2)
BCVA Snellen, median (range)	20/100 (20/200–20/63)	20/125 (20/320–20/63)
CST, mean (SD), μm	573 (103)	701 (205)
Corneal thickness, mean (SD), μm	550.6 (39.7)	548.4 (52.6)
Diabetic retinopathy severity, n (%)
Severe nonproliferative diabetic retinopathy	0	1 (10)
Laser (pan-retinal photocoagulation)	7 (100)	9 (90)

Abbreviations: BCVA, best-corrected visual acuity; CST, center subfield thickness; DME, diabetic macular edema; HbA1c, hemoglobin A1c; VEGF, vascular endothelial growth factor; SD, standard deviation.

Figure 1 Evolution of central subfield thickness after intravitreal insertion of FAc implant. P-values are for comparison with baseline value.

Abbreviations: FAc, fluocinolone acetonide; VEGF, vascular endothelial growth factor.

Table 2 Efficacy results for CST and BCVA at defined times after insertion of the fluocinolone acetate implant (intention-to-treat population)

Study visits	Group 1, prior laser only (n=7 eyes)		Group 2, prior laser and anti-VEGF (n =10 eyes)
	Mean change (SD)	P-valuea	Mean change (SD)	P-valuea
Week 1
CST, μm	−156 (58)	<0.001	−110 (114)	0.013
BCVA score, letters	+4.7 (4.7)	0.037	+4.4 (11.4)	0.255
Month 1
CST, μm	−239 (77)	<0.001	−147 (196)	0.042
BCVA score, letters	+2.0 (5.9)	0.408	+6.4 (11.8)	0.120
Month 3
CST, μm	−227 (145)	0.006	−167 (208)	0.032
BCVA score, letters	+3.7 (6.1)	0.158	+7.8 (12.4)	0.077
Month 6
CST, μm	−281 (202)	0.010	−167 (249)	0.062
BCVA score, letters	+4.3 (5.5)	0.085	+4.8 (13.5)	0.291
Month 9
CST, μm	−295 (206)	0.009	−172 (235)	0.046
BCVA score, letters	+5.3 (7.0)	0.091	0.4 (5.1)	0.939
Month 12
CST, μm	−299 (206)	0.008	−251 (269)	0.016
BCVA score, letters	+5.6 (8.7)	0.141	+0.9 (15.8)	0.861
AUC0–last, letters
All eyes	+4.21 (5.77)	0.102	+3.97 (12.07)	0.326
Pseudophakic eyesb	+4.21 (5.77)	0.102	+9.54 (6.65)	0.225

Notes:

a Compared with baseline value (Student’s t-test) for paired values.

b n=7 for group 1 and n=5 for group 2.

Abbreviations: AUC0–last, area under the curve from baseline to last value; BCVA, best-corrected visual acuity; CST, central subfield thickness; VEGF, vascular endothelial growth factor.

Figure 2 Mean gain of visual acuity after 1 year of treatment after intravitreal insertion of FAc implant (intention-to-treat population with LOCF).

Abbreviations: FAc, fluocinolone acetonide; BCVA, best-corrected visual acuity; LOCF, last observation carried forward.

Figure 3 Mean gain of visual acuity during study in pseudophakic patients (intention-to-treat population).

Abbreviations: BCVA, best-corrected visual acuity; VEGF, vascular endothelial growth factor.