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 201925 Jaffe et al, 202026 |
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 0274699124 |
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 201614 | 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 202029 | 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, 201930 | 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, 202033 | 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.