Pub Date : 2025-02-01DOI: 10.1016/j.ophtha.2024.08.017
Ursula Schmidt-Erfurth MD , Julia Mai MD , Gregor S. Reiter MD, PhD , Sophie Riedl MD, PhD , Wolf-Dieter Vogl PhD , Amir Sadeghipour PhD , Alex McKeown PhD , Emma Foos BA, MPH , Lukas Scheibler PhD , Hrvoje Bogunovic PhD
Purpose
To quantify morphological changes of the photoreceptors (PRs) and retinal pigment epithelium (RPE) layers under pegcetacoplan therapy in geographic atrophy (GA) using deep learning–based analysis of OCT images.
Design
Post hoc longitudinal image analysis.
Participants
Patients with GA due to age-related macular degeneration from 2 prospective randomized phase III clinical trials (OAKS and DERBY).
Methods
Deep learning–based segmentation of RPE loss and PR degeneration, defined as loss of the ellipsoid zone (EZ) layer on OCT, over 24 months.
Main Outcome Measures
Change in the mean area of RPE loss and EZ loss over time in the pooled sham arms and the pegcetacoplan monthly (PM)/pegcetacoplan every other month (PEOM) treatment arms.
Results
A total of 897 eyes of 897 patients were included. There was a therapeutic reduction of RPE loss growth by 22% and 20% in OAKS and 27% and 21% in DERBY for PM and PEOM compared with sham, respectively, at 24 months. The reduction on the EZ level was significantly higher with 53% and 46% in OAKS and 47% and 46% in DERBY for PM and PEOM compared with sham at 24 months. The baseline EZ-RPE difference had an impact on disease activity and therapeutic response. The therapeutic benefit for RPE loss increased with larger EZ-RPE difference quartiles from 21.9%, 23.1%, and 23.9% to 33.6% for PM versus sham (all P < 0.01) and from 13.6% (P = 0.11), 23.8%, and 23.8% to 20.0% for PEOM versus sham (P < 0.01) in quartiles 1, 2, 3, and 4, respectively, at 24 months. The therapeutic reduction of EZ loss increased from 14.8% (P = 0.09), 33.3%, and 46.6% to 77.8% (P < 0.0001) between PM and sham and from 15.9% (P = 0.08), 33.8%, and 52.0% to 64.9% (P < 0.0001) between PEOM and sham for quartiles 1 to 4 at 24 months.
Conclusions
Deep learning-based OCT analysis objectively identifies and quantifies PR and RPE degeneration in GA. Reductions in further EZ loss on OCT are even higher than the effect on RPE loss in phase 3 trials of pegcetacoplan treatment. The EZ-RPE difference has a strong impact on disease progression and therapeutic response. Identification of patients with higher EZ-RPE loss difference may become an important criterion for the management of GA secondary to AMD.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
目的：利用基于深度学习的光学相干断层扫描（OCT）图像分析方法，量化地理萎缩（GA）患者在培高康治疗下感光器（PR）和视网膜色素上皮（RPE）层的形态学变化：事后纵向图像分析：方法：基于深度学习对 SD-OCT 图像上 24 个月的 RPE 损失和 PR 退化（定义为 OCT 上椭圆形区 (EZ) 层的损失）进行分割：假治疗组和每月（PM）/每隔一个月（PEOM）治疗组的 RPE 和 EZ 平均损失面积随时间的变化 结果：共纳入了 897 名患者的 897 只眼睛。24 个月时，与假性治疗相比，OAKS 和 DERBY 的 PM/PEOM 治疗分别减少了 22%/20% 和 27%/21% 的 RPE 损耗增长。在24个月时，与假性疗法相比，OAKS和DERBY治疗PM/PEOM的EZ水平下降幅度分别为53%/46%和47%/46%。基线 EZ-RPE 差异对疾病活动性和治疗反应有影响。PM 与假体相比，随着 EZ-RPE 差异四分位数从 21.9%、23.1%、23.9% 到 33.6%（所有 pConclusion）的增大，RPE 损失增长的治疗获益也随之增加：基于 OCT 的 AI 分析客观地识别和量化了 GA 中的 PR 和 RPE 退化。OCT 上与 EZ 损失一致的 PR 退化的进一步减少甚至高于培加氯铵治疗 3 期试验中对 RPE 损失的影响。EZ-RPE 差异对疾病进展和治疗反应有很大影响。识别 EZ-RPE 损失差异较高的患者可能成为治疗继发于 AMD 的 GA 的一个重要标准。
{"title":"Disease Activity and Therapeutic Response to Pegcetacoplan for Geographic Atrophy Identified by Deep Learning-Based Analysis of OCT","authors":"Ursula Schmidt-Erfurth MD , Julia Mai MD , Gregor S. Reiter MD, PhD , Sophie Riedl MD, PhD , Wolf-Dieter Vogl PhD , Amir Sadeghipour PhD , Alex McKeown PhD , Emma Foos BA, MPH , Lukas Scheibler PhD , Hrvoje Bogunovic PhD","doi":"10.1016/j.ophtha.2024.08.017","DOIUrl":"10.1016/j.ophtha.2024.08.017","url":null,"abstract":"<div><h3>Purpose</h3><div>To quantify morphological changes of the photoreceptors (PRs) and retinal pigment epithelium (RPE) layers under pegcetacoplan therapy in geographic atrophy (GA) using deep learning–based analysis of OCT images.</div></div><div><h3>Design</h3><div>Post hoc longitudinal image analysis.</div></div><div><h3>Participants</h3><div>Patients with GA due to age-related macular degeneration from 2 prospective randomized phase III clinical trials (OAKS and DERBY).</div></div><div><h3>Methods</h3><div>Deep learning–based segmentation of RPE loss and PR degeneration, defined as loss of the ellipsoid zone (EZ) layer on OCT, over 24 months.</div></div><div><h3>Main Outcome Measures</h3><div>Change in the mean area of RPE loss and EZ loss over time in the pooled sham arms and the pegcetacoplan monthly (PM)/pegcetacoplan every other month (PEOM) treatment arms.</div></div><div><h3>Results</h3><div>A total of 897 eyes of 897 patients were included. There was a therapeutic reduction of RPE loss growth by 22% and 20% in OAKS and 27% and 21% in DERBY for PM and PEOM compared with sham, respectively, at 24 months. The reduction on the EZ level was significantly higher with 53% and 46% in OAKS and 47% and 46% in DERBY for PM and PEOM compared with sham at 24 months. The baseline EZ-RPE difference had an impact on disease activity and therapeutic response. The therapeutic benefit for RPE loss increased with larger EZ-RPE difference quartiles from 21.9%, 23.1%, and 23.9% to 33.6% for PM versus sham (all <em>P <</em> 0.01) and from 13.6% (<em>P =</em> 0.11), 23.8%, and 23.8% to 20.0% for PEOM versus sham (<em>P <</em> 0.01) in quartiles 1, 2, 3, and 4, respectively, at 24 months. The therapeutic reduction of EZ loss increased from 14.8% (<em>P =</em> 0.09), 33.3%, and 46.6% to 77.8% (<em>P <</em> 0.0001) between PM and sham and from 15.9% (<em>P =</em> 0.08), 33.8%, and 52.0% to 64.9% (<em>P <</em> 0.0001) between PEOM and sham for quartiles 1 to 4 at 24 months.</div></div><div><h3>Conclusions</h3><div>Deep learning-based OCT analysis objectively identifies and quantifies PR and RPE degeneration in GA. Reductions in further EZ loss on OCT are even higher than the effect on RPE loss in phase 3 trials of pegcetacoplan treatment. The EZ-RPE difference has a strong impact on disease progression and therapeutic response. Identification of patients with higher EZ-RPE loss difference may become an important criterion for the management of GA secondary to AMD.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found after the references.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 2","pages":"Pages 181-193"},"PeriodicalIF":13.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.ophtha.2024.08.021
Peter B. Veldman MD , Mark A. Greiner MD , Maria S. Cortina MD , Anthony N. Kuo MD , Jennifer Y. Li MD , Darby D. Miller MD, MPH , Roni M. Shtein MD, MS , Mitchell P. Weikert MD , Jia Yin MD, PhD, MPH , Stephen J. Kim MD , Joanne F. Shen MD
Objective
To evaluate the published literature on the efficacy of amniotic membrane grafting (AMG) in the management of acute chemical and thermal ocular surface burns with respect to the rate of corneal re-epithelialization and improvement of visual acuity or corneal clarity.
Methods
Literature searches were conducted in the PubMed database in May 2023 and updated in January 2024 and were limited to the English language without date restrictions. The searches yielded 474 citations; 58 were reviewed in full text, and 9 met the inclusion criteria. Four studies were rated level II, and 5 studies were rated level III. This assessment focuses on 3 level II articles that provided consistent primary and secondary outcomes but demonstrated suboptimal study design with respect to power calculations and lacked a priori sample-size calculations.
Results
Amniotic membrane grafting significantly improved corneal re-epithelialization compared with medical therapy alone in eyes with moderate-grade burns. For severely burned eyes, AMG demonstrated no advantage over medical therapy. Additionally, AMG demonstrated no significant advantage over medical therapy for improved visual acuity or corneal clarity for moderate or severe ocular surface burns.
Conclusions
The best available level II evidence suggests that AMG in the setting of acute ocular surface burns has efficacy in hastening re-epithelialization in moderate burns. As an adjuvant to medical therapy, it did not demonstrate a benefit in improving re-epithelialization in severe burns or visual acuity or corneal clarity in either moderate or severe burns.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
{"title":"Efficacy of Amniotic Membrane Grafting for the Treatment of Chemical and Thermal Ocular Surface Injuries","authors":"Peter B. Veldman MD , Mark A. Greiner MD , Maria S. Cortina MD , Anthony N. Kuo MD , Jennifer Y. Li MD , Darby D. Miller MD, MPH , Roni M. Shtein MD, MS , Mitchell P. Weikert MD , Jia Yin MD, PhD, MPH , Stephen J. Kim MD , Joanne F. Shen MD","doi":"10.1016/j.ophtha.2024.08.021","DOIUrl":"10.1016/j.ophtha.2024.08.021","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the published literature on the efficacy of amniotic membrane grafting (AMG) in the management of acute chemical and thermal ocular surface burns with respect to the rate of corneal re-epithelialization and improvement of visual acuity or corneal clarity.</div></div><div><h3>Methods</h3><div>Literature searches were conducted in the PubMed database in May 2023 and updated in January 2024 and were limited to the English language without date restrictions. The searches yielded 474 citations; 58 were reviewed in full text, and 9 met the inclusion criteria. Four studies were rated level II, and 5 studies were rated level III. This assessment focuses on 3 level II articles that provided consistent primary and secondary outcomes but demonstrated suboptimal study design with respect to power calculations and lacked a priori sample-size calculations.</div></div><div><h3>Results</h3><div>Amniotic membrane grafting significantly improved corneal re-epithelialization compared with medical therapy alone in eyes with moderate-grade burns. For severely burned eyes, AMG demonstrated no advantage over medical therapy. Additionally, AMG demonstrated no significant advantage over medical therapy for improved visual acuity or corneal clarity for moderate or severe ocular surface burns.</div></div><div><h3>Conclusions</h3><div>The best available level II evidence suggests that AMG in the setting of acute ocular surface burns has efficacy in hastening re-epithelialization in moderate burns. As an adjuvant to medical therapy, it did not demonstrate a benefit in improving re-epithelialization in severe burns or visual acuity or corneal clarity in either moderate or severe burns.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found after the references.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 2","pages":"Pages 154-163"},"PeriodicalIF":13.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471542","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}
Pub Date : 2025-02-01DOI: 10.1016/j.ophtha.2024.08.018
Armin Handzic MD , Jim Shenchu Xie MD , Nanthaya Tisavipat MD , Roisin Maire O’Cearbhaill MD , Deena A. Tajfirouz MD , Kevin D. Chodnicki MD , Eoin P. Flanagan MB, BCh , John J. Chen MD, PhD , Jonathan Micieli MD , Edward Margolin MD
<div><h3>Purpose</h3><div>This study aimed to determine whether magnetic resonance imaging (MRI) biomarkers are associated with visual prognosis in myelin oligodendrocyte protein (MOG)-associated optic neuritis (ON).</div></div><div><h3>Design</h3><div>Cross-sectional analysis.</div></div><div><h3>Participants</h3><div>Patients meeting 2023 international diagnostic criteria for MOG antibody-associated disease who were seen for first episodes of MOG-associated ON at 3 tertiary neuro-ophthalmology practices between January 2017 and July 2023 were enrolled. Patients who received < 3 months of neuro-ophthalmic follow-up and did not demonstrate visual recovery (visual acuity [VA] ≥ 20/20 and visual field mean deviation [VFMD] > –5.0 dB) during this time were excluded.</div></div><div><h3>Methods</h3><div>Patients underwent contrast-enhanced, fat-suppressed MRI of the brain and orbits within 1 month of symptom onset.</div></div><div><h3>Main Outcome Measures</h3><div>The associations between radiologic biomarkers and poor VA outcome (< 20/40), incomplete VA recovery (< 20/20), and poor VFMD outcome (VFMD < –5.0 dB) were assessed using multivariable logistic regression adjusting for time from symptom onset to treatment and nadir VA or VFMD. Radiologic biomarkers included length of optic nerve enhancement (> 25% vs. < 25%; > 50% vs. < 50%; and > 75% vs. < 75%); degree of orbital, canalicular, and intracranial or chiasmal optic nerve enhancement (mild vs. moderate to severe compared with the lacrimal gland); and absence versus presence of optic nerve sheath enhancement on baseline T1-weighted MRI.</div></div><div><h3>Results</h3><div>A total of 129 eyes of 92 patients (median age, 37.0 years [interquartile range, 20.8–51.3 years]; 65.2% female) were included. Poor VA outcome was seen in 6.2% of patients, incomplete VA recovery was seen in 19.4% of patients, and poor VFMD outcome was seen in 16.9% of patients. Compared with eyes with moderate to severe enhancement, eyes with mild orbital optic nerve enhancement were more likely to have poor VA outcome (odds ratio [OR], 8.57; 95% confidence interval [CI], 1.85–51.14; <em>P</em> = 0.009), incomplete VA recovery (OR, 7.31, 95% CI, 2.42–25.47; <em>P</em> = 0.001), and poor VFMD outcome (adjusting for time to treatment: OR, 6.81; 95% CI, 1.85–28.98; <em>P</em> = 0.005; adjusting for nadir VFMD: OR, 11.65; 95% CI, 1.60–240.09; <em>P</em> = 0.04). Lack of optic nerve sheath enhancement additionally was associated with incomplete VA recovery (OR, 3.86; 95% CI, 1.19–12.85; <em>P</em> = 0.02) compared with the presence of enhancement. These associations remained consistent in subgroup logistic regression analysis of MRIs performed before initiation of treatment but were not seen in pairwise analysis of MRIs performed after treatment.</div></div><div><h3>Conclusions</h3><div>In eyes with first MOG-associated ON episodes, milder enhancement in the orbital optic nerve was associated wit
研究目的本研究旨在确定磁共振成像（MRI）生物标志物是否与髓鞘少突胶质细胞蛋白（MOG）相关性视神经炎（MOG-ON）的视觉预后相关：设计：横断面分析：2017年1月至2023年7月期间在三家三级神经眼科诊所就诊的符合2023年国际MOG抗体相关疾病诊断标准的首次发作MOG-ON患者入选。排除接受神经眼科随访少于3个月且在此期间未显示视力恢复（视力[VA]≥20/20且视野平均偏差[VFMD]>-5.0 dB）的患者：方法：患者在症状出现后一个月内接受对比增强、脂肪抑制的脑部和眼眶 MRI 检查：主要结果测量：放射学生物标志物与不良视力评估结果之间的关联（结果：92 例患者的 129 只眼睛接受了核磁共振成像：共纳入92名患者的129只眼睛（中位数[IQR]年龄为37.0 [20.8-51.3]，65.2%为女性）。6.2%的病例视力结果不佳，19.4%的病例视力未完全恢复，16.9%的病例VFMD结果不佳。与中度-重度强化的眼睛相比，轻度眼眶视神经强化的眼睛更容易出现视力不良（OR 8.57；95% CI [1.85，51.14]，P=0.009）、视力不完全恢复（OR 7.31，95% CI [2.42，25.47]，P=0.001）和 VFMD 不良（根据治疗时间调整：调整治疗时间：OR 6.81，95% CI [1.85，28.98]，P=0.005；调整最低 VFMD：OR 11.65，95% CI [1.60，240.09]，P=0.04）。与存在视神经鞘强化相比，视神经鞘无强化与视力恢复不完全也有关系（OR 3.86，95% CI [1.19，12.85]，P=0.02）。在对开始治疗前进行的磁共振成像进行的亚组逻辑回归分析中，这些相关性保持一致，但在对治疗后进行的磁共振成像进行的配对分析中则未发现这些相关性：结论：在首次MOG-ON发作的患者中，眼眶视神经的轻度强化与较差的VA和VF恢复有关。需要进行前瞻性和机理研究，以确定 MRI 在 MOG-ON 中的预后作用。
{"title":"Radiologic Predictors of Visual Outcome in Myelin Oligodendrocyte Glycoprotein-Related Optic Neuritis","authors":"Armin Handzic MD , Jim Shenchu Xie MD , Nanthaya Tisavipat MD , Roisin Maire O’Cearbhaill MD , Deena A. Tajfirouz MD , Kevin D. Chodnicki MD , Eoin P. Flanagan MB, BCh , John J. Chen MD, PhD , Jonathan Micieli MD , Edward Margolin MD","doi":"10.1016/j.ophtha.2024.08.018","DOIUrl":"10.1016/j.ophtha.2024.08.018","url":null,"abstract":"<div><h3>Purpose</h3><div>This study aimed to determine whether magnetic resonance imaging (MRI) biomarkers are associated with visual prognosis in myelin oligodendrocyte protein (MOG)-associated optic neuritis (ON).</div></div><div><h3>Design</h3><div>Cross-sectional analysis.</div></div><div><h3>Participants</h3><div>Patients meeting 2023 international diagnostic criteria for MOG antibody-associated disease who were seen for first episodes of MOG-associated ON at 3 tertiary neuro-ophthalmology practices between January 2017 and July 2023 were enrolled. Patients who received < 3 months of neuro-ophthalmic follow-up and did not demonstrate visual recovery (visual acuity [VA] ≥ 20/20 and visual field mean deviation [VFMD] > –5.0 dB) during this time were excluded.</div></div><div><h3>Methods</h3><div>Patients underwent contrast-enhanced, fat-suppressed MRI of the brain and orbits within 1 month of symptom onset.</div></div><div><h3>Main Outcome Measures</h3><div>The associations between radiologic biomarkers and poor VA outcome (< 20/40), incomplete VA recovery (< 20/20), and poor VFMD outcome (VFMD < –5.0 dB) were assessed using multivariable logistic regression adjusting for time from symptom onset to treatment and nadir VA or VFMD. Radiologic biomarkers included length of optic nerve enhancement (> 25% vs. < 25%; > 50% vs. < 50%; and > 75% vs. < 75%); degree of orbital, canalicular, and intracranial or chiasmal optic nerve enhancement (mild vs. moderate to severe compared with the lacrimal gland); and absence versus presence of optic nerve sheath enhancement on baseline T1-weighted MRI.</div></div><div><h3>Results</h3><div>A total of 129 eyes of 92 patients (median age, 37.0 years [interquartile range, 20.8–51.3 years]; 65.2% female) were included. Poor VA outcome was seen in 6.2% of patients, incomplete VA recovery was seen in 19.4% of patients, and poor VFMD outcome was seen in 16.9% of patients. Compared with eyes with moderate to severe enhancement, eyes with mild orbital optic nerve enhancement were more likely to have poor VA outcome (odds ratio [OR], 8.57; 95% confidence interval [CI], 1.85–51.14; <em>P</em> = 0.009), incomplete VA recovery (OR, 7.31, 95% CI, 2.42–25.47; <em>P</em> = 0.001), and poor VFMD outcome (adjusting for time to treatment: OR, 6.81; 95% CI, 1.85–28.98; <em>P</em> = 0.005; adjusting for nadir VFMD: OR, 11.65; 95% CI, 1.60–240.09; <em>P</em> = 0.04). Lack of optic nerve sheath enhancement additionally was associated with incomplete VA recovery (OR, 3.86; 95% CI, 1.19–12.85; <em>P</em> = 0.02) compared with the presence of enhancement. These associations remained consistent in subgroup logistic regression analysis of MRIs performed before initiation of treatment but were not seen in pairwise analysis of MRIs performed after treatment.</div></div><div><h3>Conclusions</h3><div>In eyes with first MOG-associated ON episodes, milder enhancement in the orbital optic nerve was associated wit","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 2","pages":"Pages 170-180"},"PeriodicalIF":13.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.ophtha.2024.03.007
Ajay Kolli MD, MPH , Shreya Malli OD , Gerami D. Seitzman MD
{"title":"Lid Margin Demodex Without Eyelashes","authors":"Ajay Kolli MD, MPH , Shreya Malli OD , Gerami D. Seitzman MD","doi":"10.1016/j.ophtha.2024.03.007","DOIUrl":"10.1016/j.ophtha.2024.03.007","url":null,"abstract":"","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 2","pages":"Page e33"},"PeriodicalIF":13.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140782057","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}
Pub Date : 2025-02-01DOI: 10.1016/j.ophtha.2024.08.022
David M. Brown MD , Glenn J. Jaffe MD , Charles C. Wykoff MD, PhD , Eser Adiguzel PhD , Jeffrey S. Heier MD , Arshad M. Khanani MD, MA
Purpose
To report the safety and efficacy of brolucizumab (Beovu) 6 mg versus aflibercept (Eylea) 2 mg administered every 4 weeks in participants with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid after the week 52 up to week 104.
Study eyes were randomized 2:1 to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks for 100 weeks or until study termination.
Main Outcome Measures
All available efficacy (analysis of noninferiority in mean best-corrected visual acuity [BCVA], central subfield thickness [CST], fluid-free status [no intraretinal fluid and no subretinal fluid]) and safety data up to study termination, including data up to week 104 for those participants who completed the study before its termination. All P values after week 52 were nominal and reflect observed data for the efficacy analyses.
Results
Brolucizumab 6 mg every 4 weeks was noninferior to aflibercept 2 mg in mean BCVA change from baseline to week 104 (least squares mean difference, –0.4 ETDRS letters; 95% confidence interval [CI], –3.7 to 3.0; P = 0.0169). The proportion of eyes with ≥15-letter loss was 6.2% for brolucizumab and 4.7% for aflibercept (P = 0.7762), and a greater proportion of eyes were fluid free at week 104 (52.5% brolucizumab vs. 28.2% aflibercept; 95% CI, 11.9−37.3; P < 0.001) in eyes treated with brolucizumab versus aflibercept. Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, was 11.5% (0.8% and 2.2%) for brolucizumab versus 6.1% (0% and 0.6%) for aflibercept.
Conclusions
Consistent with 52-week results, brolucizumab 6 mg every 4 weeks was noninferior in mean BCVA change, with anatomic outcomes superior to aflibercept 2 mg every 4 weeks from baseline to week 104 or study termination. The incidence of IOI, including retinal vasculitis and retinal vascular occlusion, was higher with brolucizumab versus aflibercept; therefore, brolucizumab should not be used more frequently than every 8 weeks after the loading regimen.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
{"title":"MERLIN: Two-Year Results of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid","authors":"David M. Brown MD , Glenn J. Jaffe MD , Charles C. Wykoff MD, PhD , Eser Adiguzel PhD , Jeffrey S. Heier MD , Arshad M. Khanani MD, MA","doi":"10.1016/j.ophtha.2024.08.022","DOIUrl":"10.1016/j.ophtha.2024.08.022","url":null,"abstract":"<div><h3>Purpose</h3><div>To report the safety and efficacy of brolucizumab (Beovu) 6 mg versus aflibercept (Eylea) 2 mg administered every 4 weeks in participants with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid after the week 52 up to week 104.</div></div><div><h3>Design</h3><div>Multicenter, randomized, double-masked phase 3a study.</div></div><div><h3>Participants</h3><div>Participants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-VEGF treatment).</div></div><div><h3>Methods</h3><div>Study eyes were randomized 2:1 to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks for 100 weeks or until study termination.</div></div><div><h3>Main Outcome Measures</h3><div>All available efficacy (analysis of noninferiority in mean best-corrected visual acuity [BCVA], central subfield thickness [CST], fluid-free status [no intraretinal fluid and no subretinal fluid]) and safety data up to study termination, including data up to week 104 for those participants who completed the study before its termination. All <em>P</em> values after week 52 were nominal and reflect observed data for the efficacy analyses.</div></div><div><h3>Results</h3><div>Brolucizumab 6 mg every 4 weeks was noninferior to aflibercept 2 mg in mean BCVA change from baseline to week 104 (least squares mean difference, –0.4 ETDRS letters; 95% confidence interval [CI], –3.7 to 3.0; <em>P</em> = 0.0169). The proportion of eyes with ≥15-letter loss was 6.2% for brolucizumab and 4.7% for aflibercept (<em>P</em> = 0.7762), and a greater proportion of eyes were fluid free at week 104 (52.5% brolucizumab vs. 28.2% aflibercept; 95% CI, 11.9−37.3; <em>P</em> < 0.001) in eyes treated with brolucizumab versus aflibercept. Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, was 11.5% (0.8% and 2.2%) for brolucizumab versus 6.1% (0% and 0.6%) for aflibercept.</div></div><div><h3>Conclusions</h3><div>Consistent with 52-week results, brolucizumab 6 mg every 4 weeks was noninferior in mean BCVA change, with anatomic outcomes superior to aflibercept 2 mg every 4 weeks from baseline to week 104 or study termination. The incidence of IOI, including retinal vasculitis and retinal vascular occlusion, was higher with brolucizumab versus aflibercept; therefore, brolucizumab should not be used more frequently than every 8 weeks after the loading regimen.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found after the references.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 2","pages":"Pages 131-140"},"PeriodicalIF":13.1,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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