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经导航的激光联合阿柏西普与阿柏西普单药治疗未经治疗的分支视网膜静脉阻塞:一项 12 个月随机试验。

Navigated laser and aflibercept versus aflibercept monotherapy in treatment-naïve branch retinal vein occlusion: A 12-month randomized trial.

机构信息

Department of Ophthalmology, Odense University Hospital, Odense, Denmark.

Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

出版信息

Acta Ophthalmol. 2022 Nov;100(7):e1503-e1509. doi: 10.1111/aos.15182. Epub 2022 May 25.

Abstract

PURPOSE

Angiostatic agents have proven effective in the treatment of macular oedema in patients with branch retinal vein occlusion (BRVO). However, treatment is inconvenient and expensive, and novel treatment regimens are warranted. We aimed to evaluate if combination treatment of navigated central retinal laser and aflibercept lowered the treatment burden in these patients.

METHODS

Treatment-naïve patients with BRVO and macular oedema were included at two centres and randomized 1:1 to three monthly injections of 2.0 mg aflibercept with (Group A) or without (Group B) navigated central laser, followed by aflibercept as needed from month 4 through 12. Re-treatment need was evaluated, and secondary endpoints included functional and anatomical outcomes and safety evaluated by retinal microperimetry.

RESULTS

We evaluated 41 eyes of 41 patients with a mean age of 69.6 years. Baseline median best-corrected visual acuity (BCVA) was 70.0 letters, and median central retinal thickness (CRT) was 502 μm with no difference between Groups A (n = 21) and B (n = 20). Percentage of patients needing re-treatment after month three was 71% and 80% (p = 0.72). At month 12, groups did not differ in number of injections after loading (1 versus 2, p = 0.43), change in BCVA (+12.8 versus +15.1 letters, p = 0.48), CRT (-195 versus -181 μm, p = 0.82), or retinal sensitivity (+3.3 versus +4.1 dB, p = 0.67).

CONCLUSION

In treatment-naïve BRVO patients, addition of navigated central laser to aflibercept did not lower treatment burden or affect functional or anatomical outcomes. A low number of intravitreal injections were needed for successful outcome in both treatment arms.

摘要

目的

血管生成抑制剂已被证明在治疗视网膜分支静脉阻塞(BRVO)患者的黄斑水肿方面有效。然而,这种治疗方法既不方便又昂贵,因此需要新的治疗方案。我们旨在评估导航中心视网膜激光联合阿柏西普是否能降低这些患者的治疗负担。

方法

在两个中心纳入未经治疗的 BRVO 和黄斑水肿患者,并按 1:1 比例随机分为三组,每月接受 2.0mg 阿柏西普注射治疗,其中一组(A 组)联合导航中心激光治疗,另一组(B 组)不联合治疗,然后从第 4 个月至第 12 个月按需接受阿柏西普治疗。评估再次治疗的需求,次要终点包括功能和解剖学结果,并通过视网膜微视野评估安全性。

结果

我们评估了 41 名 41 只眼患者的情况,平均年龄为 69.6 岁。基线时最佳矫正视力(BCVA)中位数为 70.0 个字母,中央视网膜厚度(CRT)中位数为 502μm,A 组(n=21)和 B 组(n=20)之间无差异。在第 3 个月后需要再次治疗的患者比例分别为 71%和 80%(p=0.72)。在第 12 个月时,两组在负荷期后注射次数(1 次与 2 次,p=0.43)、BCVA 变化(+12.8 与 +15.1 个字母,p=0.48)、CRT 变化(-195 与-181μm,p=0.82)或视网膜敏感度变化(+3.3 与 +4.1dB,p=0.67)方面均无差异。

结论

在未经治疗的 BRVO 患者中,导航中心激光联合阿柏西普并不能降低治疗负担,也不会影响功能或解剖学结果。在这两种治疗方案中,都需要较少的玻璃体内注射来获得成功的结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a0b5/9790367/37e91ab5fc7e/AOS-100-e1503-g001.jpg

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