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 物理 天体生物学
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.
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
PDF的下载单位、IP信息已删除 (2025-6-4)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
刚刚
cocobear完成签到 ,获得积分10
1秒前
欢城发布了新的文献求助10
2秒前
研友_CCQ_M完成签到,获得积分10
4秒前
沟通亿心完成签到,获得积分10
4秒前
争气完成签到 ,获得积分10
5秒前
乾坤完成签到,获得积分10
6秒前
完美的友蕊应助木木三采纳,获得10
6秒前
JudgeGoodwin完成签到,获得积分10
8秒前
Jzhaoc580完成签到 ,获得积分10
8秒前
Jeffrey完成签到,获得积分10
8秒前
11秒前
猪肉铺完成签到,获得积分10
11秒前
李晨晨完成签到 ,获得积分10
11秒前
橘灯完成签到,获得积分10
13秒前
狂野元枫完成签到 ,获得积分10
13秒前
15秒前
夏夏发布了新的文献求助10
15秒前
lgf完成签到,获得积分10
17秒前
南浔完成签到 ,获得积分10
17秒前
欢城完成签到,获得积分10
18秒前
晗晗有酒窝完成签到,获得积分10
18秒前
shenglll完成签到 ,获得积分10
18秒前
18秒前
祁乾完成签到 ,获得积分10
20秒前
等待谷南完成签到,获得积分10
21秒前
南城雨落完成签到,获得积分10
22秒前
djbj2022发布了新的文献求助10
23秒前
futianyu完成签到 ,获得积分0
28秒前
Akim应助科研通管家采纳,获得20
29秒前
飞快的盼易完成签到,获得积分10
30秒前
纯真的德地完成签到 ,获得积分10
30秒前
Michael完成签到 ,获得积分10
32秒前
魏凡之完成签到,获得积分10
33秒前
Neo完成签到,获得积分10
34秒前
yulong完成签到 ,获得积分10
37秒前
xiong完成签到,获得积分10
37秒前
sherwing2009发布了新的文献求助10
37秒前
YBR完成签到 ,获得积分10
38秒前
忧虑的花卷完成签到,获得积分10
38秒前
高分求助中
A new approach to the extrapolation of accelerated life test data 1000
Cognitive Neuroscience: The Biology of the Mind 1000
Technical Brochure TB 814: LPIT applications in HV gas insulated switchgear 1000
Immigrant Incorporation in East Asian Democracies 600
Nucleophilic substitution in azasydnone-modified dinitroanisoles 500
不知道标题是什么 500
A Preliminary Study on Correlation Between Independent Components of Facial Thermal Images and Subjective Assessment of Chronic Stress 500
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 遗传学 基因 物理化学 催化作用 冶金 细胞生物学 免疫学
热门帖子
关注 科研通微信公众号,转发送积分 3968578
求助须知:如何正确求助?哪些是违规求助? 3513393
关于积分的说明 11167478
捐赠科研通 3248836
什么是DOI,文献DOI怎么找? 1794499
邀请新用户注册赠送积分活动 875131
科研通“疑难数据库(出版商)”最低求助积分说明 804664