Jaffe Glenn J, Martin Daniel, Callanan David, Pearson P Andrew, Levy Brian, Comstock Timothy
Duke University Eye Center, Duke University Medical Center, Durham, North Carolina 27710, USA.
Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
To report the interim 34-week safety and efficacy results of a 3-year study to evaluate an investigational intravitreal fluocinolone acetonide (FA) implant in patients with noninfectious posterior uveitis.
Prospective, dose-masked, dose-randomized, historically controlled, multicenter trial in patients with unilateral or bilateral disease.
A total of 278 patients with recurrent noninfectious posterior uveitis were randomized to receive a 0.59-mg (n = 110) or 2.1-mg (n = 168) implant. In patients with bilateral disease, the more severely affected eye received the implant.
The implant was inserted surgically into the vitreous cavity through a pars plana incision. Follow-up visits were scheduled on day 2, week 1, and then every 4 to 6 weeks through 34 weeks after implantation. Systemic, periocular, and topical therapies were reduced as allowed by the clinical response.
The primary efficacy outcome was a comparison of the recurrence rate in the implanted eye from the 34 weeks before implantation to the 34 weeks after implantation. Visual acuity (VA), need for adjunctive therapy, and safety also were assessed.
Combining both doses, the FA implant reduced the rate of recurrences from 51.4% in the 34 weeks preceding implantation to 6.1% postimplantation (P<0.0001) in the study eyes. Comparatively, there was a significant increase in the recurrence rate in the fellow nonimplanted eyes from 20.3% preimplantation to 42.0% postimplantation (P<0.0001). Visual acuity was stabilized or improved in 87% of implanted eyes and generally was associated with reductions in the area of macular hyperfluorescence. The percentage of eyes that required systemic medications, periocular injections, and topical corticosteroids decreased from 52.9%, 63.0%, and 35.7%, respectively, preimplantation to 12.1%, 2.2%, and 16.5% postimplantation (P< or =0.0001 in all cases). At week 34, 51.1% of implanted eyes required ocular antihypertensive drops, and 5.8% underwent glaucoma filtering surgery. Lens opacity scores increased by > or =2 grades in 19.8% of phakic implanted eyes, and 9.9% required cataract surgery. There were no statistically significant differences in any of the parameters studied for the 0.59-mg implant, compared with the 2.1-mg implant.
The FA implant significantly reduced uveitis recurrences, improved VA, and decreased the need for adjunctive therapy in the studied patient population. The most common side effects included increased intraocular pressure and cataract progression.
报告一项为期3年的研究的34周中期安全性和有效性结果，该研究旨在评估一种用于非感染性后葡萄膜炎患者的玻璃体内注射曲安奈德（FA）植入物。
对单侧或双侧疾病患者进行的前瞻性、剂量盲法、剂量随机、历史对照、多中心试验。
共有278例复发性非感染性后葡萄膜炎患者被随机分为接受0.59毫克（n = 110）或2.1毫克（n = 168）植入物。对于双侧疾病患者，病情较重的眼睛接受植入物。
通过平坦部切口将植入物手术插入玻璃体腔。术后第2天、第1周进行随访，然后在植入后34周内每4至6周进行一次随访。根据临床反应酌情减少全身、眼周和局部治疗。
主要疗效指标是比较植入眼在植入前34周与植入后34周的复发率。还评估了视力（VA）、辅助治疗需求和安全性。
综合两种剂量，FA植入物使研究眼中的复发率从植入前34周的51.4%降至植入后的6.1%（P<0.0001）。相比之下，未植入的对侧眼的复发率从植入前的20.3%显著增加至植入后的42.0%（P<0.0001）。87%的植入眼视力稳定或提高，且通常与黄斑高荧光面积减少有关。需要全身用药、眼周注射和局部使用皮质类固醇的眼的百分比分别从植入前的52.9%、63.0%和35.7%降至植入后的12.1%、2.2%和16.5%（所有情况P≤0.0001）。在第34周时，51.1%的植入眼需要使用降眼压滴眼液，5.8%的患者接受了青光眼滤过手术。在有晶状体的植入眼中，19.8%的患者晶状体混浊评分增加≥2级，9.9%的患者需要进行白内障手术。与2.1毫克植入物相比，0.59毫克植入物在任何研究参数上均无统计学显著差异。
FA植入物显著降低了葡萄膜炎复发率，改善了视力，并减少了研究患者群体对辅助治疗的需求。最常见的副作用包括眼压升高和白内障进展。
