Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment

Figures & data

Table 1 Summary of Published Studies for Injectable Fluocinolone Acetonide Implants in Non-Infectious Uveitis (0.18 mg and 0.19 mg)

Authors, Year	Evidence Level	Uveitis Description	Intervention and Type of Study	Details	Extracted Outcomes	Follow-Up (Months)
Jaffe et al 2019^Citation25 Jaffe et al, 2020^Citation26	1	NIU-PS in ≥1 eye for ≥1 year & ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids	0.2 μg/day FAi or sham (2:1 randomisation). Multi-centre, randomized, prospective, double-masked, sham-controlled 3-year phase 3 clinical trial NCT01694186	129 patients FAi treated n=87, sham n= 42. Multi-centre, worldwide	Difference between the proportion of FA & sham-treated patients with uveitis recurrence (6 months) Secondary outcomes: time to first recurrence, no. of recurrences, BCVA, resolution of CME, CRT & number of adjunctive treatments. Adverse events: IOP, cataract development & surgery, conjunctival haemorrhage, discomfort and eye pain	6, 12 36
NCT 02746991^Citation24	1	NIU-PS	0.2 μg/day 0.18 mg FAi or sham. Phase 3 study	153 patients FAi treated n=101,sham=52 Multi-centre, India	Adjunctive systemic and local therapy CME, BCVA, IOP and cataract	36
Jaffe 2016^Citation14	2	NIU-PS and anterior and intermediate uveitis	Non-comparative, interventional, dose-randomised, dose-masked, prospective, interventional study of 0.18mg FAi doses: 0.2 μg/day (n=5) vs 0.5 μg/day (n=6) (1:1 randomisation)	11 patients, 11 eyes USA	Uveitis activity, BCVA, adjuvant systemic and local therapy, safety parameters (BCVA, IOP and need to control with medication and/or surgery), subjective ocular tolerability and discomfort	24
Cai 2020^Citation29	3	Chronic NIU-PS and anterior and intermediate uveitis	Retrospective longitudinal extension study from prospective trial of 0.18mg FAi	12 patients, 12 eyes USA	Primary: Time to disease recurrence or time to CME Secondary: BCVA, IOP, cataract and adverse events	Mean 34.2 (range 12.0–56.9)
Weber, 2019^Citation30	4	Chronic NIU-PS CME	0.19mg FAi Retrospective observational case series study	8 patients, 11 eyes Germany	CRT, uveitis activity, BCVA, IOP	Median 19 (range 8–24)
Ajamil Rodanes et al, 2020^Citation33	4	Birdshot chorioretinopathy	0.19mg FAi Single-center, retrospective, interventional case series	11 patients, 15 eyes UK	FFA leakage/ICG lesion change, CME, ERG function. IOP, cataract	Mean 31 (range 12–36)

Abbreviations: FAi, fluocinolone acetonide implant; NIU-PS, non-infectious uveitis affecting the posterior segment; CME, cystoid macular edema; BCVA, best-corrected visual acuity; IOP, intraocular pressure; FFA, fundus fluorescein angiography, ICG, indocyanine green angiography; ERG, electroretinogram.

Table 2 Summary of Outcomes of Phase 3 Clinical Trial Evaluation of Fluocinolone Implant versus Sham in Chronic Non-Infectious Uveitis Until 36-Months

	Jaffe et al 2019, 2020 NCT01694186^Citation25,Citation26		NCT02746991^Citation24,Citation27,Citation28
	Implant n = 87	Sham n= 42	Implant n=101	Sham n=52
Outcome	Uveitis recurrence
Total number of recurrences within 6 mo	36	70	59	53
Total number of recurrences within 36 mo	149	223	n.a.	n.a.
Percentage of eyes with recurrence within 6 mo	28	91	26	60
Percentage of eyes with recurrence within 12 mo	38	98	n.a.	n.a.
Percentage of eyes with recurrence within 36 mo	66	98	47	75
Median no. of recurrences per study eye by 12 mo (median time/days)	0.7 (378)	2.5 (75)	n.a (1116)	n.a (191)
Mean no. of recurrences per study eye by 36 mo ±SD (median time/days)	1.7±2.4 (657)	5.3±3.8 (71)
	Need for adjunctive therapy
No. of recurrences within 6 mo requiring systemic steroid or immunosuppressant	21	24	25	14
No. of recurrences within 6 morequiring intra/periocular steroid	5	35	2	19
No. of recurrences within 6 morequiring topical steroid	17	22	11	17
Adjunctive local injection meds by 12 mo (% eyes)	7	62	n.a.	n.a
Adjunctive local injection meds by 36 mo (% eyes)	20	69	9	52
Any adjunctive treatments by 36 mo (% eyes)	58	98	n.a.	n.a.
Mean no of adjunctive treatment per eye by 36 mo	0.5	1.5	n.a.	n.a.
Adjunctive systemic medication by 12 mo (% eyes)	19	40	n.a.	n.a.
Adjunctive systemic medication by 36 mo (% eyes)	35	50	32	33
	Cystoid macular edema (CME)
CME resolution by 12 mo (% eyes)	71	48	n.a.	n.a.
CME resolution by 36 mo (% eyes)	n.a	n.a	76	54
	Cataract surgery
Cataract surgery within 12 mo (% eyes)	33	5	18%	11%
Cataract surgery within 36 mo (% eyes)	74	24	0.71%	27%
	Intraocular pressure (IOP)
IOP meds within 12mo (% eyes)	26	26	n.a.	n.a.
IOP meds within 36 mo (% eyes)	43	33	74	73
IOP >25 up to month 36 (% eyes)	24	24	n.a.	n.a.
IOP >30 up to month 36 (% eyes)	16	12	n.a.	n.a.
IOP at 36mo	14.5±5.1	14.8±5.3	14.8	13.4
Mean change from baseline IOP at 36 mo	0.8±5.0	1.4±5.7	n.a.	n.a.
IOP surgery within 12 mo (% eyes)	n.a.	n.a.	1	0
IOP surgery within 36 mo (% eyes)	6	12	2	0
	Visual acuity (VA) and uveitis activity
VA gain >15 letters* at 36 mo (% eyes)	33	15	n.a.	n.a.
VA mean change 36 mo letters*(SD)	+9.1(13)	+2.5 (14)	n.a.	n.a.
No AC cells at 36 mo (% eyes)	85	85	n.a.	n.a.
No vitreous haze at 36 mo (% eyes)	89	91	n.a.	n.a.

Notes: 36 month data for NCT02746991 sourced from published conference abstract/press release. *letters, Early Treatment Diabetic Retinopathy Study letters.

Abbreviations: mo, months; No, number; SD, standard deviation; d, days; CME, cystoid macular oedema; IOP, intraocular pressure (mmHg); meds, medication; %, percentage; VA, visual acuity; n.a., not available or not applicable; AC, anterior chamber.

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