Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network
Abstract
:1. Introduction
2. Methods
3. Results
3.1. Patients’ Characteristics at Baseline
3.2. Functional and Anatomical Outcomes of FAi
3.3. Systemic Treatments
3.4. Exploratory Predictive Factors of Functional and Anatomical Response to FAi
3.5. Predictive Factors of Rescue DEXi Injections
3.6. Adverse Events
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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n = 26 Eyes (22 Patients) | n (%) or Mean ± SD (Range) |
---|---|
Gender (females), n (%) | 16 (73.1%) |
Mean age (years) | 60.4 ± 15.8 (31–87) |
Mean follow-up duration (months) | 11.4 ± 2.0 (3–12) |
Uveitis type, n (%) | |
Anterior Intermediate Posterior Panuveitis | 0 (0%) 3 (11.5%) 9 (34.6%) 14 (53.8%) |
Etiology of uveitis, n (%) | |
Idiopathic Sarcoidosis Vogt–Koyanagi–Harada Autoimmune HLA-B27+ Immune restauration syndrome | 15 (57.7%) 5 (19.2%) 2 (7.7%) 2 (7.7%) 1 (3.8%) 1 (3.8%) |
Baseline signs of inflammation, n (%) | |
Anterior chamber cells Vitreous haze Vasculitis Optic nerve swelling Macular edema Serous retinal detachment (SRD) Cystoid spaces Hyper-reflective foci (HRF) Disorganization of the inner retinal layers (DRIL) | 11 (42.3%) 17 (65.4%) 10 (38.5%) 10 (38.5%) 26 (100%) 10 (38.5%) 19 (73.1%) 14 (53.8%) 8 (30.8%) |
Lens status before FAi, n (%) | |
Pseudophakic | 25 (96.2%) |
Number of antiglaucoma drops before FAi, n (%) | |
0 1 2 3 4 | 20 (76.9%) 3 (11.5%) 3 (11.5%) 0 (0%) 0 (0%) |
Number of DEXi per eye before FAi, n (%) | |
Not mentioned 2–5 5–10 10–20 >20 Mean number (per eye) | 2 (7.7%) 7 (26.9%) 11 (42.3%) 5 (19.2%) 1 (3.8%) 8.5 ± 6.1 (2–33) |
Use of systemic treatments before FAi, n (%) Corticosteroids only Immunosuppressive treatment only Corticosteroids + immunosuppressive treatment | 13 (59.1%) 3 (13.6%) 5 (22.7%) 5 (22.7%) |
Baseline | After Latest DEXi | After FAi | ||||
---|---|---|---|---|---|---|
M2 | M1 | M3 | M6 | M12 | ||
n (%) or Mean ± SD (Range) | ||||||
Eyes | 26 | 26 | 24 | 24 | 23 | 24 |
BCVA (LogMAR), Mean ± SD (range) | 0.43 ± 0.36 (1.40–0) | 0.37 ± 0.44 (1.40–0) | 0.32 ± 0.45 (1.70–0.08) | 0.21 ± 0.27 (1.10–0.08) | 0.18 ± 0.23 (1–0.08) | 0.27 ± 0.35 (1.30–0.08) |
Central macular thickness (µm), Mean ± SD (range) | 429 ± 112 (275–617) | 293 ± 56 (216–439) | 307 ± 65 (226–483) | 317 ± 91 (218–544) | 320 ± 86 (223–591) | 321 ± 85 (217–626) |
Intraocular pressure (mmHg), Mean ± SD (range) | 12.9 ± 3.5 (8–21) | 13.9 ± 6.3 (5–25) | 12.9 ± 6.4 (5–33) | 11.0 ± 3.4 (5–21) | 13.8 ± 4.1 (7–26) | 11.1 ± 3.1 (7–19) |
Glaucoma treatment, n (%) | ||||||
None Monotherapy Dual therapy Triple therapy Quadruple therapy Filtering surgery | 20 (71.4%) 3 (11.5%) 3 (11.5%) 0 (0%) 0 (0%) 0 (0%) | 15 (57.7%) 4 (15.4%) 5 (19.2%) 0 (0%) 0 (0%) 2 (7.7%) | 15 (62.5%) 3 (12.5%) 6 (25.0%) 0 (0%) 0 (0%) 0 (0%) | 13 (54.2%) 2 (8.3%) 7 (29.2%) 0 (0%) 2 (8.3%) 0 (0%) | 12 (52.2%) 2 (8.7%) 7 (30.4%) 0 (0%) 2 (8.7%) 0 (0%) | 13 (54.2%) 2 (8.3%) 7 (29.2%) 0 (0%) 2 (8.3%) 0 (0%) |
Anterior chamber cells (+) a, Mean ± SD (range) | 0.8 ± 1.2 (0–3) | 0.0 ± 0.0 (0–0) | 0.0 ± 0.0 (0–0) | 0.08 ± 0.3 (0–1) | 0.0 ± 0.0 (0–0) | 0.2 ± 0.6 (0–2) |
Anterior chamber cells, N (%) | 11 (42.3%) | 1 (3.8%) | 0 (0%) | 1 (4.2%) | 0 (0%) | 0 (0%) |
Vitreous Haze (+) a, Mean ± SD (range) | 1.11 ± 0.80 (0–3) | 0.14 ± 0.40 (0–1) | 0.11 ± 0.20 (0–0.5) | 0.04 ± 0.10 (0–0.5) | 0.0 ± 0.0 (0–0) | 0.0 ± 0.0 (0–0) |
Vitritis, n (%) | 17 (65.4%) | 4 (15.4%) | 2 (8.3%) | 1 (4.2%) | 0 (0%) | 0 (0%) |
Optic nerve swelling, n (%) | 10 (38.5%) | 4 (15.4%) | 1 (4.2%) | 0 (0%) | 0 (0%) | 0 (0%) |
Retinal vasculitis, n (%) | 10 (38.5%) | 1 (3.8%) | 1 (4.2%) | 1 (4.2%) | 0 (0%) | 0 (0%) |
Dexamethasone rescue injection, n (%) | / | / | 0 (0%) | 2 (8.3%) | 4 (17.4%) | 3 (12.5%) |
FAi reinjection, n (%) | / | / | 0 (0%) | 0 (0%) | 0 (0%) | 1 (4.2%) |
Baseline | After Latest DEXi | After FAi | ||||
---|---|---|---|---|---|---|
M2 | M1 | M3 | M6 | M12 | ||
n (%) or Mean ± SD (Range) | ||||||
Eyes | 26 | 26 | 24 | 24 | 23 | 24 |
Presence of macular edema, n (%) HRF SRD Cystoid spaces DRIL | 26 (100%) 14 (53.8%) 10 (38.5%) 19 (73.1%) 8 (30.8%) | 9 (34.6%) 6 (23.1%) 0 (0%) 9 (34.6%) 3 (11.5%) | 4 (16.7%) 1 (4.1%) 1 (4.1%) 3 (12.5%) 0 (0%) | 4 (16.7%) 2 (8.3%) 1 (4.1%) 3 (12.5%) 2 (8.3%) | 4 (17.4%) 2 (8.7%) 1 (4.3%) 4 (17.4%) 2 (8.7%) | 7 (29.2%) 5 (20.8%) 1 (4.1%) 3 (12.5%) 4 (16.6%) |
Complete resolution of UME, n (%) | / | 17 (65.4%) | 20 (83.3%) | 20 (83.3%) | 19 (82.6%) | 17 (70.8%) |
Incomplete resolution of UME, n (%) | / | 2 (7.6%) | 2 (8.3%) | 1 (4.1%) | 1 (4.3%) | 2 (8.3%) |
Absence of CMT decrease, n (%) | 3 (11.5%) | 0 (0%) | 2 (8.3%) | 2 (8.7%) | 4 (16.6%) |
Baseline | After Latest DEXi | After FAi | ||||
---|---|---|---|---|---|---|
M1 | M3 | M6 | M12 | |||
n (%) or Mean ± SD (Range) | ||||||
Patients | 22 | 22 | 20 | 20 | 19 | 20 |
Associated systemic treatment, n (%) Corticosteroids (CS) only Immunosuppressive (IS) therapy only CS + IS | 13 (59.1%) 3 (13.6%) 5 (22.7%) 5 (22.7%) | 11 (50.0%) 3 (13.6%) 6 (27.2%) 2 (9.1%) | 10 (50.0%) 5 (25.0%) 4 (20.0%) 1 (5.0%) | 10 (50.0%) 5 (25.0%) 4 (20.0%) 1 (5.0%) | 10 (52.6%) 5 (26.3%) 4 (21.1%) 1 (5.3%) | 9 (45.0%) 2 (10.0%) 4 (20.0%) 3 (15.0%) |
CS dose (milligrams) among treated, Mean ± SD (range) | 12.4 ± 5.6 (5–20) | 10.6 ± 5.3 (5–20) | 9.5 ± 5.4 (4–20) | 8.9 ± 5.0 (4–20) | 8.8 ± 5.1 (3–20) | 8.3 ± 6.2 (3–20) |
CS dose, p-value vs. baseline | Ref | 0.50 | 0.19 | 0.19 | 0.19 | 0.37 |
Anti TNF, n (%) | 4 (18.2%) | 5 (22.7%) | 3 (15.0%) | 3 (15.0%) | 3 (15.8%) | 5 (25.0%) |
Interferon, n (%) | 1 (4.5%) | 1 (4.5%) | 1 (5.0%) | 1 (5.0%) | 1 (5.3%) | 1 (5.0%) |
Methotrexate, n (%) | 3 (13.6%) | 3 (13.6%) | 3 (15.0%) | 3 (15.0%) | 3 (15.8%) | 3 (15.0%) |
Hydroxychloroquine, n (%) | 1 (4.5%) | 1 (4.5%) | 1 (5.0%) | 1 (5.0%) | 1 (5.3%) | 1 (5.0%) |
Tocilizumab, n (%) | 2 (9.1%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) |
Best Result during Follow-up | 12 Month Follow-up | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Mean BCVA Gain (LogMAR) | p | Mean CMT Decrease (µm) | p | Complete Anatomical Response n (%) | p | Mean BCVA Gain (LogMAR) | p | Mean CMT Decrease (µm) | p | Complete Anatomical Response n (%) | p | |
Age | ||||||||||||
-<60 years ->60 years | 0.27 0.16 | Ref 0.47 | 110 178 | Ref 0.08 | 12 (100%) 12 (86%) | Ref 0.48 | 0.17 0.20 | Ref 0.25 | 61 154 | Ref 0.20 | 10 (83.3%) 7 (58.3%) | Ref 0.37 |
Gender | ||||||||||||
-Female -Male | 0.27 0.16 | Ref 0.48 | 110 178 | Ref 0.25 | 18 (94.7%) 6 (85.7%) | Ref 0.47 | 0.23 0.07 | Ref 0.23 | 77 191 | Ref 0.14 | 12 (66.7%) 5 (83.3%) | Ref 0.63 |
Etiology of uveitis | ||||||||||||
-Idiopathic -Sarcoidosis -Others | 0.20 0.17 0.35 | Ref 0.66 0.65 | 143 140 96 | Ref 0.88 0.40 | 15 (100%) 4 (80.0%) 5 (83.3%) | Ref 0.25 0.29 | 0.13 0.17 0.33 | Ref 0.83 0.04 | 128 92 81 | Ref 0.86 0.34 | 12 (80.0%) 3 (75.0%) 2 (40%) | Ref 1 0.13 |
Type of uveitis | ||||||||||||
-Posterior -Intermediate -Panuveitis | 0.36 0.15 0.17 | Ref 0.71 0.24 | 11 115 129 | Ref 0.48 0.90 | 8 (88.9%) 3 (100%) 13 (92.9%) | Ref 1 1 | 0.31 0.07 0.09 | Ref 0.60 0.26 | 100 223 96 | Ref 0.33 0.74 | 6 (66.7%) 2 (100%) 9 (69.2%) | Ref 1 1 |
Number of previous DEXi | ||||||||||||
-1–5 -6–10 ->10 | 0.22 0.24 0.32 | Ref 0.81 0.55 | 53 193 58 | Ref 0.07 1 | 5 (83.3%) 10 (90.9%) 6 (100%) | Ref 1 1 | 0.22 0.16 0.24 | Ref 1 0.97 | −13 188 46 | Ref 0.03 0.69 | 3 (60%) 6 (60%) 5 (83.3) | Ref 1 0.42 |
Complete anatomic response to DEXi | ||||||||||||
-No -Yes | 0.34 0.19 | Ref 0.51 | 90 89 | Ref 0.82 | 4 (66.7%) 15 (100%) | Ref 0.07 | 0.36 0.11 | Ref 0.45 | 24 71 | Ref 0.55 | 1 (25.0%) 11 (73.3%) | Ref 0.12 |
Partial anatomic response to DEXi | ||||||||||||
-No -Yes | 0.44 0.16 | Ref 0.53 | 102 65 | Ref 1 | 2 (50.0%) 2 (100%) | Ref 0.47 | 0.45 0.08 | Ref 0.80 | 16 49 | Ref 1 | 0 (0%) 1 (100%) | Ref 0.25 |
Vitritis grade a: | ||||||||||||
-<1+ -≥1+ | 0.28 0.22 | Ref 0.38 | 145 119 | Ref 0.53 | 13 (100.0%) 11 (84.6%) | Ref 0.48 | 0.21 0.17 | Ref 0.61 | 122 98 | Ref 0.54 | 9 (69.2%) 8 (72.7%) | Ref 1 |
Posterior inflammation other than UME | ||||||||||||
-No -Yes | 0.28 0.23 | Ref 0.51 | 172 115 | Ref 0.36 | 9 (100.0%) 15 (88.2%) | Ref 0.53 | 0.23 0.17 | Ref 0.41 | 147 95 | Ref 0.48 | 6 (66.7%) 11 (73.3%) | Ref 1 |
Associated systemic treatment at the initial visit: | ||||||||||||
-None -CS only -IS rx only -CS + IS rx | 0.40 0.10 0.18 0.16 | Ref 0.14 0.71 0.35 | 145 172 107 121 | Ref 1 0.67 0.67 | 5 (71.4%) 3 (100%) 5 (100%) 7 (100%) | Ref 1 0.47 1 | 0.38 0.09 0.14 0.06 | Ref 0.31 0.86 0.52 | 83 171 101 101 | Ref 0.55 0.91 0.91 | 4 (57.1%) 3 (100%) 3 (75.0%) 5 (71.4%) | Ref 0.29 1 1 |
Presence of biomarkers HRF | ||||||||||||
-None -Presence SRD -None -Presence DRIL -None -Presence | 0.11 0.33 0.35 0.07 0.16 0.32 | Ref 0.17 Ref 0.03 Ref 0.15 | 79 163 121 143 152 160 | Ref 0.09 Ref 0.75 Ref 0.95 | 11 (91.7%) 13 (92.3%) 15 (93.7%) 9 (90.0%) 13 (92.9%) 7 (87.5%) | Ref 1 Ref 1 Ref 1 | 0.04 0.28 0.28 0.01 0.12 0.25 | Ref 0.26 Ref 0.05 Ref 0.16 | 43 151 100 126 139 138 | Ref 0.07 Ref 0.87 Ref 0.92 | 8 (72.7%) 9 (69.2%) 10 (62.5%) 7 (87.5%) 10 (83.3%) 5 (62.5%) | Ref 1 Ref 0.35 Ref 0.35 |
Eyes without Additional DEXi n = 20 | Eyes with at Least One Rescue DEXi n = 6 | p-Value | |
---|---|---|---|
Age | |||
-<60 years ->60 years | 10 (83.3%) 10 (71.4%) | 2 (16.7%) 4 (28.6%) | Ref 0.65 |
Gender | |||
-Female -Male | 16 (84.2%) 4 (57.1%) | 3 (15.8%) 3 (42.9%) | Ref 0.29 |
Etiology of uveitis | |||
-Idiopathic -Sarcoidosis -Others | 12 (80.0%) 5 (100%) 3 (50.0%) | 3 (20.0%) 0 (0%) 3 (50.0%) | Ref 0.54 0.29 |
Type of uveitis | |||
-Posterior -Intermediate -Panuveitis | 5 (55.6%) 3 (100%) 12 (85.7%) | 4 (44.4%) 0 (0%) 2 (14.3%) | Ref 0.49 0.16 |
Number of previous DEXi | |||
-1–5 -6–10 ->10 -No data | 6 (85.7%) 7 (63.4%) 5 (83.3%) 2 (100%) | 1 (16.7%) 4 (36.4%) 1 (16.7%) 0 (0%) | Ref 0.60 1 - |
Complete anatomic response to DEXi | |||
-No -Yes -No data | 5 (83.3%) 10 (66.7%) 5 (100%) | 1 (16.7%) 5 (33.3%) 0 (0%) | Ref 0.62 - |
Partial anatomic response to DEXi | |||
-No * -Yes ** | 3 (75.0%) 2 (100%) | 1 (25.0%) 0 (0.0%) | Ref 1 |
Associated systemic treatment at Baseline | |||
-None -Corticosteroids only -Immunosuppressive rx only -Corticosteroids + immunosuppressive rx -No data | 5 (55.6%) 3 (100%) 6 (100%) 4 (66.7%) 2 (100%) | 4 (44.4%) 0 (0%) 0 (0%) 2 (33.3%) 0 (0%) | Ref 0.49 0.10 0.49 - |
Presence of biomarkers at baseline | |||
HRF -None -Presence SDR -None -Presence DRIL -None -Presence -No data | 11 (91.7%) 9 (64.3%) 11 (68.7%) 9 (90.0%) 14 (100%) 2 (25.0%) 4 (100%) | 1 (8.33%) 5 (35.7%) 5 (31.3%) 1 (10.0%) 0 (0%) 6 (75.0%) 0 (0%) | Ref 0.17 Ref 0.35 Ref <0.001 - |
Baseline | After Latest DEXi | After FAi | ||||
---|---|---|---|---|---|---|
M2 | M1 | M3 | M6 | M12 | ||
n (%) or Mean ± SD (Range) | ||||||
Eyes | 26 | 26 | 24 | 24 | 23 | 24 |
Intraocular pressure (mmHg), Mean ± SD (range) | 12.9 ± 3.5 (8–21) | 13.9 ± 6.3 (5–25) | 12.9 ± 6.4 (5–33) | 11.0 ± 3.4 (5–21) | 13.8 ± 4.1 (7–26) | 11.1 ± 3.1 (7–19) |
p-value vs. baseline | Ref | 0.42 | 0.81 | 0.08 | 0.06 | 0.08 |
Eyes with IOP > 21 mmHg, n (%) | 0 (0%) | 3 (11.5%) | 2 (8.3%) | 0 (0%) | 1 (4.3%) | 0 (0%) |
p-value vs. baseline | Ref | 0.62 | 0.62 | 1 | 1 | 1 |
Eyes with IOP > 30 mmHg, n (%) | 0 (0%) | 1 (3.8%) | 1 (4.2%) | 0 (0%) | 0 (0%) | 0 (0%) |
p-value vs. baseline | Ref | 1 | 0.50 | 1 | 1 | 1 |
Glaucoma treatment, n (%) | ||||||
No treatment Monotherapy Dual therapy Triple therapy Quadruple therapy Filtering surgery | 20 (71.4%) 3 (11.5%) 3 (11.5%) 0 (0%) 0 (0%) 0 (0%) | 15 (57.7%) 4 (15.4%) 5 (19.2%) 0 (0%) 0 (0%) 2 (7.7%) | 15 (62.5%) 3 (12.5%) 6 (25.0%) 0 (0%) 0 (0%) 0 (0%) | 13 (54.2%) 2 (8.3%) 7 (29.2%) 0 (0%) 2 (8.3%) 0 (0%) | 12 (52.2%) 2 (8.7%) 7 (30.4%) 0 (0%) 2 (8.7%) 0 (0%) | 13 (54.2%) 2 (8.3%) 7 (29.2%) 0 (0%) 2 (8.3%) 0 (0%) |
n of anti-glaucoma drops, Mean ± SD (range) | 0.35 ± 0.70 | 0.50 ± 0.81 | 0.35 ± 0.75 | 0.92 ± 1.30 | 0.88 ± 1.30 | 0.88 ± 1.30 |
p-value vs. baseline | Ref | 0.73 | 0.98 | 0.05 | 0.08 | 0.08 |
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Jabbour, M.; Kodjikian, L.; Bourdin, A.; Rougier, M.-B.; Serrar, Y.; Weber, M.; Massé, H.; Mazhar, D.; Perez-Roustit, S.; Chiquet, C.; et al. Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network. J. Pers. Med. 2024, 14, 245. https://doi.org/10.3390/jpm14030245
Jabbour M, Kodjikian L, Bourdin A, Rougier M-B, Serrar Y, Weber M, Massé H, Mazhar D, Perez-Roustit S, Chiquet C, et al. Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network. Journal of Personalized Medicine. 2024; 14(3):245. https://doi.org/10.3390/jpm14030245
Chicago/Turabian StyleJabbour, Matthieu, Laurent Kodjikian, Alexandre Bourdin, Marie-Bénédicte Rougier, Yasmine Serrar, Michel Weber, Hélène Massé, Driss Mazhar, Sara Perez-Roustit, Christophe Chiquet, and et al. 2024. "Efficacity and Safety of the Fluocinolone Acetonide Implant in Uveitic Macular Edema: A Real-Life Study from the French Uveitis Network" Journal of Personalized Medicine 14, no. 3: 245. https://doi.org/10.3390/jpm14030245