Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial.

Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial.
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DOI:
10.1016/j.ophtha.2018.08.021
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发表时间:
2019-03
期刊:
影响因子:
13.7
通讯作者:
Multicenter Uveitis Steroid Treatment Trial Research Group
Multicenter Uveitis Steroid Treatment Trial Research Group
中科院分区:
医学1区
文献类型:
--
作者:
Thorne JE;Sugar EA;Holbrook JT;Burke AE;Altaweel MM;Vitale AT;Acharya NR;Kempen JH;Jabs DA;Multicenter Uveitis Steroid Treatment Trial Research Group

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评估三种局部皮质类固醇注射治疗葡萄膜炎性黄斑水肿的疗效比较:眼周曲安奈德 (PTA)、玻璃体内曲安奈德 (ITA) 和玻璃体内地塞米松植入物 (IDI)。多中心随机临床试验 葡萄膜炎性黄斑水肿患者 患者按 1:1:1 随机接受三种疗法中的一种。双侧黄斑水肿患者双眼接受相同的治疗。主要结果是由蒙面读者通过光学相干断层扫描 (OCT) 评估的 8 周时基线 (PropBL) 中心子区域厚度 (CST) 的比例(8 周时的 CST/BL 时的 CST)。次要结局包括 24 周内黄斑水肿、最佳矫正视力 (BCVA) 和眼压 (IOP) 事件改善和消退≥20%。所有治疗组在随访期间均表现出 CST 改善。第 8 周时,各组的 CST 相对于基线都有临床意义的降低(PropBL:分别为 0.77、0.61 和 0.54,这意味着 PTA、ITA 和 IDI 分别降低 23%、39% 和 46%)。玻璃体内注射曲安奈德(PropBL ITA/PropBL PTA,99.87% 置信区间 [CI]:0.79, 0.65–0.96)和 IDI(PropBL IDI/PropBL PTA,99.87% CI:0.69, 0.56–0.86)比 PTA 具有更大的 CST 降低幅度(p <0.0001)。 8周时玻璃体内地塞米松植入物不劣于ITA(PropBL IDI/PropBL ITA,99.87%CI:0.88,0.71-1.08)。 ITA 和 IDI 治疗在改善和解决葡萄膜黄斑水肿方面也优于 PTA 治疗。所有治疗组在整个随访过程中均表现出 BCVA 改善。 8 周时,ITA 和 IDI 组的 BCVA 均有改善,比 PTA 组高 5 个字母(p <0.004)。与眼周治疗组相比,玻璃体内治疗组 IOP ≥24 mmHg 的风险更高(ITA 和 IDI 的风险比 [HR],95% CI:分别为 1.83、0.91-3.65 和 2.52、1.29-4.91);然而,两个玻璃体内治疗组之间没有显着差异。玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎性黄斑水肿方面优于 PTA,但会适度增加 IOP 升高的风险。这种风险在玻璃体内治疗之间没有显着差异。在一项为期 6 个月的多中心、随机、比较试验中,玻璃体内曲安西龙和玻璃体内地塞米松植入物在治疗葡萄膜炎性黄斑水肿方面均优于眼周曲安西龙。玻璃体内治疗之间的眼压升高没有显着差异。
To evaluate the comparative effectiveness of three regional corticosteroid injections for uveitic macular edema: periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI). Multicenter randomized clinical trial Patients with uveitic macular edema Patients were randomized 1:1:1 to receive one of the three therapies. Patients with bilateral macular edema were assigned the same treatment for both eyes. The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at BL) assessed with optical coherence tomography (OCT) by masked readers. Secondary outcomes included ≥20% improvement and resolution of macular edema, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks. All treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, 99.87% Confidence Interval [CI]: 0.79, 0.65–0.96) and IDI (PropBL IDI/PropBL PTA, 99.87% CI: 0.69, 0.56–0.86) had larger reductions in CST than PTA (p <0.0001). Intravitreal dexamethasone implant was non-inferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, 99.87%CI: 0.88, 0.71–1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic macular edema. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than the PTA group at 8 weeks (p <0.004). The risk of having IOP ≥24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (Hazard ratio [HR], 95% CI: 1.83, 0.91–3.65 and 2.52, 1.29–4.91 for ITA and IDI, respectively); however, there was no significant difference between the two intravitreal treatment groups. Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic macular edema with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments. In a 6-month multicenter, randomized, comparative trial, both intravitreal triamcinolone and intravitreal dexamethasone implant were superior to periocular triamcinolone for treating uveitic macular edema. Intraocular pressure elevation did not differ significantly between the intravitreal treatments.
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