当前位置: X-MOL 学术Ophthalmology › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
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.
Ophthalmology ( IF 13.7 ) Pub Date : 2018-09-27 , DOI: 10.1016/j.ophtha.2018.08.021
Jennifer E Thorne 1 , Elizabeth A Sugar 2 , Janet T Holbrook 3 , Alyce E Burke 3 , Michael M Altaweel 4 , Albert T Vitale 5 , Nisha R Acharya 6 , John H Kempen 7 , Douglas A Jabs 8 ,
Affiliation  

PURPOSE To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI). DESIGN Multicenter, randomized clinical trial. PARTICIPANTS Patients with uveitic ME. METHODS Patients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes. MAIN OUTCOME MEASURES The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ≥20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks. RESULTS 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, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in 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 (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups. CONCLUSIONS Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

中文翻译:

眼周曲安西龙与玻璃体内曲安西龙与玻璃体内地塞米松植入物治疗葡萄膜炎性黄斑水肿:眼周与玻璃体内皮质类固醇治疗葡萄膜炎性黄斑水肿 (POINT) 试验。

目的 评估 3 种局部皮质类固醇注射治疗葡萄膜炎性黄斑水肿 (ME) 的比较效果: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)。设计多中心、随机临床试验。参与者 葡萄膜炎 ME 患者。方法 患者按 1:1:1 随机分配接受 3 种疗法中的 1 种。双侧 ME 患者的双眼均接受相同的治疗。主要结果测量 主要结果是 8 周时基线 (PropBL) 中央亚区厚度 (CST) 的比例(8 周时的 CST/基线时的 CST)由蒙面读者用 OCT 评估。次要结局包括 24 周内 ME、最佳矫正视力 (BCVA) 和眼压 (IOP) 事件≥20% 的改善和分辨率。结果 所有治疗组在随访期间均表现出改善的 CST。在 8 周时,每组 CST 相对于基线有临床意义的降低(PropBL:分别为 0.77、0.61 和 0.54,这意味着 PTA、ITA 和 IDI 分别降低了 23%、39% 和 46% )。玻璃体内注射曲安奈德(PropBL ITA/PropBL PTA,风险比 [HR],0.79;99.87% 置信区间 [CI],0.65-0.96)和 IDI(PropBL IDI/PropBL PTA,HR,0.69;99.87% CI,0.56-0.86 ) CST 的降低幅度大于 PTA (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,HR,0.88;99.87% CI,0.71-1.08)。ITA 和 IDI 治疗在改善和解决葡萄膜炎 ME 方面也优于 PTA 治疗。在整个随访过程中,所有治疗组均表现出 BCVA 改善。在 8 周时,ITA 和 IDI 组的 BCVA 都比 PTA 组提高了 5 个字母(P < 0.004)。与眼周组相比,玻璃体内治疗组眼压≥24 mmHg 的风险更高(ITA 和 IDI 的 HR,1.83;95% CI,0.91-3.65 和 HR,2.52;95% CI,1.29-4.91,分别); 然而,两个玻璃体内治疗组之间没有显着差异。结论 玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎 ME 方面优于 PTA,但眼压升高的风险适度增加。这种风险在玻璃体内治疗之间没有显着差异。与眼周组相比,玻璃体内治疗组眼压≥24 mmHg 的风险更高(ITA 和 IDI 的 HR,1.83;95% CI,0.91-3.65 和 HR,2.52;95% CI,1.29-4.91,分别); 然而,两个玻璃体内治疗组之间没有显着差异。结论 玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎 ME 方面优于 PTA,但眼压升高的风险适度增加。这种风险在玻璃体内治疗之间没有显着差异。与眼周组相比,玻璃体内治疗组眼压≥24 mmHg 的风险更高(ITA 和 IDI 的 HR,1.83;95% CI,0.91-3.65 和 HR,2.52;95% CI,1.29-4.91,分别); 然而,两个玻璃体内治疗组之间没有显着差异。结论 玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎 ME 方面优于 PTA,但眼压升高的风险适度增加。这种风险在玻璃体内治疗之间没有显着差异。结论 玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎 ME 方面优于 PTA,但眼压升高的风险适度增加。这种风险在玻璃体内治疗之间没有显着差异。结论 玻璃体内注射曲安奈德和 IDI 在治疗葡萄膜炎 ME 方面优于 PTA,但眼压升高的风险适度增加。这种风险在玻璃体内治疗之间没有显着差异。
更新日期:2018-09-27
down
wechat
bug