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IF 10.9 1区医学

Ophthalmology Pub Date : 2026-09-07 DOI: 10.1016/j.ophtha.2026.08.022

David Cui, Priya M Mathews, Esen K Akpek

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REPLY. 对“人工晶状体置换眼睛人工晶状体度数新计算公式”评论的回复。

IF 10.9 1区医学

Ophthalmology Pub Date : 2026-09-07 DOI: 10.1016/j.ophtha.2026.08.038

Li Wang, Douglas D Koch

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Efficacy and Safety of Satralizumab for Thyroid Eye Disease: Week 24 Results from the Phase III SatraGO-1 and SatraGO-2 Randomized Trials. Satralizumab治疗甲状腺眼病的疗效和安全性：SatraGO-1和SatraGO-2随机试验的第24周结果

IF 10.9 1区医学

Ophthalmology Pub Date : 2026-09-07 DOI: 10.1016/j.ophtha.2026.08.039

César A Briceño, Oluwatobi O Idowu, Jwu Jin Khong, Thomas Kuenzel, Ann Q Tran, Christopher Brittain, Atsushi Azumi, Laura Brockwell, Nima Ghadiri, Mariano Coronel, Thorsten Ruf, Dongmei Li, Mario Salvi, Antonio Manuel Garrido-Hermosilla, Giulio Barteselli, Santiago Ortiz-Perez

{"title":"Efficacy and Safety of Satralizumab for Thyroid Eye Disease: Week 24 Results from the Phase III SatraGO-1 and SatraGO-2 Randomized Trials.","authors":"César A Briceño, Oluwatobi O Idowu, Jwu Jin Khong, Thomas Kuenzel, Ann Q Tran, Christopher Brittain, Atsushi Azumi, Laura Brockwell, Nima Ghadiri, Mariano Coronel, Thorsten Ruf, Dongmei Li, Mario Salvi, Antonio Manuel Garrido-Hermosilla, Giulio Barteselli, Santiago Ortiz-Perez","doi":"10.1016/j.ophtha.2026.08.039","DOIUrl":"10.1016/j.ophtha.2026.08.039","url":null,"abstract":"Purpose: To evaluate the primary efficacy and safety of satralizumab, an anti-interleukin-6 receptor antibody, in patients with thyroid eye disease (TED).Design: SatraGO-1 (NCT05987423) and SatraGO-2 (NCT06106828) are identically designed, 72-week, double-masked, placebo-controlled, multicenter, 2-stage randomization phase III trials.Participants: Aged ≥18 years with active, moderate-to-severe TED (Clinical Activity Score [CAS] ≥3 for ≤12 months) or inactive TED (CAS <3 for ≥6 months).Methods: Participants (SatraGO-1: N = 131; SatraGO-2: N = 127) were randomized 1:1 to receive loading doses of subcutaneous satralizumab or placebo at weeks 0, 2, and 4, followed by an every-4-week dosing regimen through week 20 (part 1).Main outcome measures: The primary end point was the proportion of participants with active TED who achieved a proptosis response (≥2-mm reduction from baseline) at week 24. Secondary end points included the proportion of participants with a ≥2-point CAS reduction, disease inactivation (CAS of 0 or 1), and an ≥1-grade diplopia reduction at week 24. Efficacy outcomes were also reported for the combined active and inactive TED population. Safety was assessed in all participants exposed to the study treatment.Results: In participants with active TED, the satralizumab arm of both trials consistently showed an increased proportion achieving a proptosis response (SatraGO-1: 49.0% vs. 31.2%; P = 0.0715; SatraGO-2: 52.9% vs. 23.4%; P = 0.0011), CAS reduction (SatraGO-1: 78.0% vs. 54.9%; P = 0.0120; SatraGO-2: 89.6% vs. 63.3%; P = 0.0009), CAS of 0 or 1 (SatraGO-1: 68.0% vs. 45.1%; P = 0.0146; SatraGO-2: 68.8% vs. 40.8%; P = 0.0042), and diplopia reduction (SatraGO-1: 44.4% vs. 34.4%; P = 0.3371; SatraGO-2: 60.7% vs. 25.8%; P = 0.0044) compared with placebo, although not all comparisons reached statistical significance. Similar clinical benefits were observed in the combined active and inactive TED population. Satralizumab was well tolerated, with low rates of serious adverse events, treatment discontinuations, and infections, and no serious infections.Conclusions: Satralizumab demonstrated clinically meaningful improvements in proptosis, CAS, and diplopia and had a favorable safety profile in participants with TED. Interleukin-6 pathway inhibition with subcutaneous satralizumab represents an efficacious and well-tolerated treatment option for patients with TED.Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":" ","pages":""},"PeriodicalIF":10.9,"publicationDate":"2026-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Valsalva-Associated Preretinal Hemorrhage with Prepapillary Vascular Loops. 瓣膜相关性视网膜前出血伴毛细血管前袢。

IF 10.9 1区医学

Ophthalmology Pub Date : 2026-09-04 DOI: 10.1016/j.ophtha.2026.08.016

Tingye Zhou, Chun Yang

引用次数: 0

Beyond Big Data: Building Trustworthy Real-World Evidence in Ophthalmology. 超越大数据：在眼科中建立可信赖的真实证据。

IF 10.9 1区医学

Ophthalmology Pub Date : 2026-09-03 DOI: 10.1016/j.ophtha.2026.08.015

Gui-Shuang Ying, Huilin Tang

引用次数: 0

Unmasking Peripheral Retinal Ischemia in Shaken Baby Syndrome. 揭露摇晃婴儿综合征的外周视网膜缺血。