A novel intravitreal fluocinolone acetonide implant (Iluvien^®) in the treatment of patients with chronic diabetic macular edema that is insufficiently responsive to other medical treatment options: a case series

Figures & data

Table 1 Patient demographics and baseline values

Patients (n)	10
Eyes (n)	15
Mean age, (years) [range]	69.2 [52–83]
SD	9.5
Sex
Male, n (%)	9 (90.0)
Female, n (%)	1 (10.0)
BCVA at baseline – range	0.1–0.6
CFT (μm)a at baseline – range	291–729
IOP (mmHg) at baseline – range	12–19

Notes:

a For five eyes no baseline values for CFT were taken.

Abbreviations: BCVA, best-corrected visual acuity; CFT, central fovea thickness; IOP, intraocular pressure; SD, standard deviation.

Table 2 Individual patients: age, sex, best-corrected visual acuity (BCVA) at baseline, and prior medical treatments

Patient number	Sex (m/f)	Age (years)	Eye	BCVA at baseline	Prior medical treatment
					VEGF-antagonists	Corticosteroids
1	m	52	RE	0.25	Ran (3)	Tri (1) [10 mg], Dex (1)
			LE	0.25	Ran (3)	Tri (1) [10 mg], Dex (1)
2	f	64	RE	0.25	Bev (4), Ran (2)
			LE	0.2	Bev (3)
3	m	72	RE	0.3	Bev (14), Ran (5)	Tri (1) [4 mg], Tri (6) [25 mg]
			LE	0.6	Bev (15), Ran (4)	Tri (1) [10 mg], Tri (6) [25 mg]
4	m	83	LE	0.1	Ran (3), Bev (1)	Tri (1) [10 mg]
5	m	75	LE	0.4	Ran (3)
6	m	68	RE	0.32	Bev (3)	Tri (1) [4 mg], Tri (1) [10 mg]
7	m	77	LE	0.1	Ran (7), Bev (2)	Tri (2) [10 mg]
8	m	76	RE	0.2	Ran (6), Bev (1)	Tri (1) [4 mg]
9	m	57	RE	0.3	Bev (4), Ran (5)	Tri (4) [10 mg], Tri (1) [25 mg]
			LE	0.25	Bev (6), Ran (5)	Tri (4) [10 mg], Tri (1) [25 mg]
10	m	68	RE	0.1	Bev (9), Ran (6)	Tri (7) [10 mg] Tri (2) [25 mg], Dex (1)
			LE	0.1	Ran (5), Bev (7)	Tri (2) [10 mg], Dex (2)

Notes: Numbers in parentheses indicate the number of injections. Squared brackets indicate dosage.

Abbreviations: Bev, bevacizumab (1.25 mg); Dex, dexamethasone implant (700 μg); f, female; LE, left eye; m, male; Ran, ranibizumab (0.5 mg); RE, right eye; Tri, triamcinolone; VGEF, vascular endothelial growth factor.

Table 3 Individual patients: BCVA, CFT, and IOP pre- and postoperatively

Patient number	Eye	Follow-up (weeks)	Type of treatment	BCVA [pre/post]	Delta BCVA [post–pre]	CFT (μm) [pre/post]	IOP (mmHg) [pre/post]
1	RE	31	A/C	[0.25/1.0]a	+0.75	[406/321]	[16/15]
	LE	30	A/C	[0.25/0.8]a	+0.55	[491/381]	[16/35]
2	RE	7	A	[0.25/0.6]	+0.35	[541/240]	[18/26]
	LE	9	A	[0.2/0.4]	+0.20	[504/210]	[18/25]
3	RE	36	A/C	[0.3/0.5]	+0.20	[291/222]	[14/15]
	LE	35	A/C	[0.6/1.0]	+0.40	[297/228]	[12/16]
4	LE	2	A/C	[0.1/0.2]	+0.10	[nd/371]	[19/19]
5	LE	8	A	[0.4/0.4]	±0	[nd/nd]	[14/17]
6	RE	9	A/C	[0.32/0.4]	±0.08	[nd/300]	[19/21]
7	LE	13	A/C	[0.1/0.1]	±0	[nd/253]	[17/15]
8	RE	25	A/C	[0.2/0.1]	−0.10	[nd/312]	[16/10]
9	RE	26	A/C	[0.3/0.6]	+0.30	[729/355]	[12/20]
	LE	21	A/C	[0.25/0.3]	+0.05	[661/396]	[14/21]
10	RE	37	A/C	[0.1/0.1]	±0	[497/251]	[14/20]
	LE	36	A/C	[0.1/0.05]	−0.05	[677/427]	[14/19]

Notes: Values for last post-op follow-up visit given.

a Preplanned cataract surgery conducted 5–6 weeks after the intravitreal injection of 190-μg FAc implant.

Abbreviations: A, prior treatment with VEGF antagonists; A/C, prior treatment with VEGF antagonists followed by a treatment with corticosteroids; BCVA, best-corrected visual acuity (decimal scale); CFT, central fovea thickness; IOP, intraocular pressure; LE, left eye; nd, no OCT data available in the registry; RE, right eye; VEGF, vascular endothelial growth factor.

Figure 1 BCVA at the preop versus the last follow-up visit for each individual patient.

Notes: Above the line: increase in BCVA. On the line: no change in BCVA. Below the line: decrease in BCVA. Mean follow-up period: 21.7 weeks (range: 2–37 weeks).
Abbreviation: BCVA, best-corrected visual acuity.

Figure 2 CFT at the preop visit versus the last follow-up visit for each individual eye.

Notes: Above the line: increase in CFT. On the line: no change in CFT. Below the line: decrease in CFT. Mean follow-up period: 21.7 weeks (range: 2–37 weeks).
Abbreviation: CFT, central fovea thickness.

Figure 3 Fluorescence angiographic findings for patient number 5, left eye pre- and 2 months postinjection of 190 μg FAc. The intravitreal injection of FAc took place on September 26, 2013.

Abbreviation: FAc, fluocinolone acetonide.

Figure 4 IOP at the preop visit versus the last follow-up visit for all individual eyes.

Notes: Above the line: increase in IOP. On the line: no change in IOP. Below the line: decrease in IOP. Mean follow-up period: 21.7 weeks (range: 2–37 weeks).
Abbreviation: IOP, intraocular pressure.

Figure 5 Data from patient number 2 showing OCT scans at pre- and postop visits.

Abbreviation: OCT, optical coherence tomography.

Figure 6 Data from patient number 2 showing BCVA at preop and postop visits.

Abbreviation: BCVA, best-corrected visual acuity.

Figure 7 Data from patient number 2 showing CFT at preop and postop visits.

Abbreviation: CFT, central fovea thickness.

Figure 8 Data from patient number 3 showing OCT scans at pre- and postop visits.

Abbreviation: OCT, optical coherence tomography.

Figure 9 Data from patient number 3 showing visual acuity (BCVA) at preop and postop visits.

Abbreviation: BCVA, best-corrected visual acuity.

Figure 10 Data from patient number 3 showing CFT at pre- and postop visits.

Abbreviation: CFT, central fovea thickness.