Effect of a Fluocinolone Acetonide Insert on Recurrence Rates in Noninfectious Intermediate, Posterior, or Panuveitis

医学 氟辛醇酮 葡萄膜炎 皮质类固醇 眼科 视力 黄斑水肿 外科 耐火材料(行星科学) 随机对照试验 水肿 天体生物学 物理
作者
Glenn J. Jaffe,Carlos Pavésio
出处
期刊:Ophthalmology [Elsevier BV]
卷期号:127 (10): 1395-1404 被引量:71
标识
DOI:10.1016/j.ophtha.2020.04.001
摘要

PurposeTo examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS).DesignPhase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186).ParticipantsAdults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids.MethodsParticipants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment.Main Outcome MeasuresThe primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments.ResultsOne hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P < 0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P < 0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively).ConclusionsFluocinolone acetonide insert–treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes. To examine the 36-month efficacy and safety of a 0.2 μg/day fluocinolone acetonide insert (FAi) to treat noninfectious uveitis of the posterior segment (NIU-PS). Phase 3, prospective, double-masked, multicenter study (clinicaltrials.gov, NCT01694186). Adults (≥18 years old) with a diagnosis of NIU-PS in ≥1 eye for ≥1 year and ≥2 recurrences of uveitis requiring systemic corticosteroid, immunosuppressive treatment, or intraocular corticosteroids. Participants were randomized 2:1 to FAi or sham (injection plus standard of care) treatment. The primary outcome was the difference between the proportion of FAi-treated and sham-treated patients who had a uveitis recurrence. Secondary outcomes included time to first recurrence, number of recurrences, best-corrected visual acuity (BCVA) change from baseline, resolution of macular edema, and number of adjunctive treatments. One hundred twenty-nine participants (n = 87 FAi-treated; n = 42 sham-treated) were enrolled. Over 36 months of treatment, cumulative uveitis recurrences were significantly reduced with FAi compared with sham (65.5% vs. 97.6%, respectively; P < 0.001); time to first recurrence was commensurately longer (median 657.0 and 70.5 days, respectively; P < 0.001). The number of recurrences per eye was significantly lower in the FAi-treated compared with the sham-treated group (mean 1.7 vs. 5.3, respectively, P < 0.001). At 36 months, more FAi-treated eyes had a ≥15-letter increase in BCVA from baseline and fewer FAi-treated eyes had investigator-determined macular edema at month 36 compared with sham-treated eyes (33.3% vs. 14.7% and 13.0% vs. 27.3% for BCVA and macular edema, respectively). Fewer FAi compared with sham-treated participants required adjunctive treatments (57.5% vs. 97.6%, respectively). Intraocular pressure (IOP) was similar for both study groups at month 36 (mean ± standard deviation 14.5±5.1 and 14.8±5.3, respectively), and approximately half as many eyes in the FAi-treated group when compared with the sham-treated group underwent IOP-lowering surgery (5.7% vs. 11.9%). Cataract surgery was required more frequently over 36 months in the FAi-treated compared with the sham-treated group (73.8% vs. 23.8% of eyes, respectively). Fluocinolone acetonide insert–treated eyes had significantly reduced uveitis recurrence rates throughout the study duration, significantly increased recurrence-free durations, fewer recurrence episodes among those with recurrences, less adjunctive therapy, and an acceptable side-effect profile compared with sham-treated eyes.
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