Pub Date : 2025-04-01DOI: 10.1016/j.oret.2024.10.001
Jan Hamouz MD , Agnieszka Nowosielska MD , Anna Święch-Zubilewicz MD , Santiago Abengoechea MD , Kristine Baumane MD , Attila Vajas MD , Małgorzata Siewierska MD , Milan Veselovsky MD , Miroslav Veith MD , Ágnes Kerényi MD , Shobhana Mange MD , Krishnapada Baidya MD , Guna Laganovska MD , Ignasi Jürgens MD , András Papp MD , Jignesh Gosai MD , Jana Štefanickova MD , Mei Han MD , Piotr Fryczkowski MD , Dominik Zalewski MD , Wenbin Wei MD
Objective
This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).
Design
This was a multicenter, double-masked, randomized, controlled phase III trial.
Participants
Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.
Methods
Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks.
Main Outcome Measures
The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between −3.49 and +3.49.
Results
Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, −2.23 to 0.13) and 95% CI (−2.46 to 0.36) of the difference between the 2 treatment groups (P = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.
Conclusions
QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration","authors":"Jan Hamouz MD , Agnieszka Nowosielska MD , Anna Święch-Zubilewicz MD , Santiago Abengoechea MD , Kristine Baumane MD , Attila Vajas MD , Małgorzata Siewierska MD , Milan Veselovsky MD , Miroslav Veith MD , Ágnes Kerényi MD , Shobhana Mange MD , Krishnapada Baidya MD , Guna Laganovska MD , Ignasi Jürgens MD , András Papp MD , Jignesh Gosai MD , Jana Štefanickova MD , Mei Han MD , Piotr Fryczkowski MD , Dominik Zalewski MD , Wenbin Wei MD","doi":"10.1016/j.oret.2024.10.001","DOIUrl":"10.1016/j.oret.2024.10.001","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).</div></div><div><h3>Design</h3><div>This was a multicenter, double-masked, randomized, controlled phase III trial.</div></div><div><h3>Participants</h3><div>Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.</div></div><div><h3>Methods</h3><div>Patients received intravitreal injection of QL1205 or reference ranibizumab at a dose of 0.5 mg in the study eye once every 4 weeks for 48 weeks.</div></div><div><h3>Main Outcome Measures</h3><div>The primary end point was change in best-corrected visual acuity (BCVA) by ETDRS letters at week 8 compared with baseline level. Biosimilarity of QL1205 to reference ranibizumab was assessed with an equivalence range for the difference in BCVA letters between −3.49 and +3.49.</div></div><div><h3>Results</h3><div>Between June 27, 2019 and June 8, 2021, 616 patients were randomized to the QL1205 group (n = 308) and the reference ranibizumab group (n = 308). The mean improvement of BCVA was +6.3 ± 9.13 ETDRS letters in the QL1205 group and +7.3 ± 8.82 ETDRS letters in the reference ranibizumab group at week 8. Both the 90% confidence interval (CI, −2.23 to 0.13) and 95% CI (−2.46 to 0.36) of the difference between the 2 treatment groups (<em>P</em> = 0.1434) were within the predefined equivalence range. Safety profiles were manageable in both groups.</div></div><div><h3>Conclusions</h3><div>QL1205 was biosimilar to reference ranibizumab regarding clinical efficacy, ocular and systemic safety, as well as immunogenicity and pharmacokinetics profiles in the treatment of patients with nAMD.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 4","pages":"Pages 343-351"},"PeriodicalIF":4.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142400909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-01DOI: 10.1016/j.oret.2024.10.018
Aurora Pecaku MD , Isabela Martins Melo MD , Jessica A. Cao BA , Shiva Sabour MD , Sumana C. Naidu MD , Sueellen Demian MD , Marko M. Popovic MD, MPH , Charles C. Wykoff MD, PhD , Andrea Govetto MD, PhD , Rajeev H. Muni MD, MSc
Objective
To describe the sequential morphological changes of the outer retina after full-thickness macular hole (FTMH) formation utilizing a novel, objective staging system based on OCT, and to determine its association with baseline visual acuity, duration of symptoms, and postoperative visual acuity at 3 months.
Design
Retrospective, observational, multicenter study.
Participants
Patients with idiopathic FTMH presenting to St. Michael’s Hospital, Toronto, Canada, and Retina Consultants of Texas, Houston, Texas from 2009 to 2022.
Methods
The medical charts of 1000 patients with FTMH were reviewed, and those with ≥2 preoperative spectral-domain OCTs (SD-OCTs) were analyzed. A staging system was developed by assessing outer retinal morphology on successive SD-OCT central foveal scans.
Main Outcome Measures
Sequential outer retinal morphological changes with SD-OCT over time and their association with baseline visual acuity, duration of symptoms, and postoperative functional outcomes.
Results
Fifty-two eyes of 52 patients with a mean age of 65.4 ± 8.4 years were included. Sequential outer retinal morphologic changes at the FTMH borders occurred in 4 distinct and reproducible stages: stage A, separation of the neurosensory retina from the retinal pigment epithelium with the well-defined external limiting membrane (ELM), ellipsoid zone (EZ), and interdigitation zone (4/52, 7.7%); stage B, thickening of the EZ (27/52, 52.0%); stage C, patchy (moth-eaten) photoreceptor loss (16/52, 30.7%); and stage D, severe or complete loss of inner and outer segments and bare ELM (5/52, 9.6%). When assessing the preoperative OCT scans closest to the time of surgery, over a mean follow-up period of 288.9 ± 350.4 days (range, 5–1841), 28.85% (15/52) of eyes were in stage B, 28.85% (15/52) were in stage C, and 42.3% (22/52) were in stage D. There was a statistically significant association between increasing stage at baseline and longer duration of macular hole symptoms (P = 0.032) and worse visual acuity at baseline (P < 0.001). Additionally, patients presenting with stages B and C at the time point closest to surgery had better visual acuity outcomes 3 months postoperatively than those with stage D (P = 0.04).
Conclusions
This SD-OCT staging system describes the sequential in vivo morphologic changes after FTMH formation, providing a novel imaging biomarker.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的利用基于光学相干断层扫描（OCT）的新型客观分期系统，描述全厚黄斑孔形成后外视网膜的连续形态变化，并确定其与基线视力、症状持续时间和术后3个月视力的关系：设计：回顾性、观察性、多中心研究：2009-2022年期间在加拿大多伦多圣迈克尔医院和美国休斯敦德克萨斯州视网膜顾问公司就诊的特发性全厚黄斑孔（FTMH）患者：方法：对 1000 名 FTMH 患者的病历进行了审查，并对至少进行过两次术前 SD-OCT 检查的患者进行了分析。通过评估连续SD-OCT中心眼窝扫描的视网膜外层形态，建立了一套分期系统：主要结果指标：SD-OCT视网膜外层形态随时间的连续变化及其与基线视力、症状持续时间和术后功能结果的关系：共纳入 52 名患者的 52 只眼睛，平均年龄为 65.4 ± 8.4 岁。FTMH 边界处视网膜外层形态的连续变化分为以下 4 个不同且可重复的阶段：A期：神经感觉视网膜与RPE分离，外缘膜（ELM）、椭圆体区（EZ）和连接区（IDZ）清晰可见（4/52，7.6%）；B期：EZ增厚（27/52，51.9%）；C期：斑片状（虫蛀状）感光体缺失（16/52，30.7%）；D期：IS和OS严重或完全缺失和/或ELM裸露（5/52，9.6%）。当评估最接近手术时间的术前 OCT 扫描结果时，在平均 288.9 天（SD 350.4，[5 -1841]）的随访期内，28.8%（15/52）的眼睛处于 B 期，28.8%（15/52）处于 C 期，42.3%（22/52）处于 D 期：这一 SD-OCT 分期系统描述了 FTMH 形成后体内形态的连续变化，提供了一种新的成像生物标志物。
{"title":"Morphologic Stages of Full-Thickness Macular Hole on Spectral-Domain OCT","authors":"Aurora Pecaku MD , Isabela Martins Melo MD , Jessica A. Cao BA , Shiva Sabour MD , Sumana C. Naidu MD , Sueellen Demian MD , Marko M. Popovic MD, MPH , Charles C. Wykoff MD, PhD , Andrea Govetto MD, PhD , Rajeev H. Muni MD, MSc","doi":"10.1016/j.oret.2024.10.018","DOIUrl":"10.1016/j.oret.2024.10.018","url":null,"abstract":"<div><h3>Objective</h3><div>To describe the sequential morphological changes of the outer retina after full-thickness macular hole (FTMH) formation utilizing a novel, objective staging system based on OCT, and to determine its association with baseline visual acuity, duration of symptoms, and postoperative visual acuity at 3 months.</div></div><div><h3>Design</h3><div>Retrospective, observational, multicenter study.</div></div><div><h3>Participants</h3><div>Patients with idiopathic FTMH presenting to St. Michael’s Hospital, Toronto, Canada, and Retina Consultants of Texas, Houston, Texas from 2009 to 2022.</div></div><div><h3>Methods</h3><div>The medical charts of 1000 patients with FTMH were reviewed, and those with ≥2 preoperative spectral-domain OCTs (SD-OCTs) were analyzed. A staging system was developed by assessing outer retinal morphology on successive SD-OCT central foveal scans.</div></div><div><h3>Main Outcome Measures</h3><div>Sequential outer retinal morphological changes with SD-OCT over time and their association with baseline visual acuity, duration of symptoms, and postoperative functional outcomes.</div></div><div><h3>Results</h3><div>Fifty-two eyes of 52 patients with a mean age of 65.4 ± 8.4 years were included. Sequential outer retinal morphologic changes at the FTMH borders occurred in 4 distinct and reproducible stages: stage A, separation of the neurosensory retina from the retinal pigment epithelium with the well-defined external limiting membrane (ELM), ellipsoid zone (EZ), and interdigitation zone (4/52, 7.7%); stage B, thickening of the EZ (27/52, 52.0%); stage C, patchy (moth-eaten) photoreceptor loss (16/52, 30.7%); and stage D, severe or complete loss of inner and outer segments and bare ELM (5/52, 9.6%). When assessing the preoperative OCT scans closest to the time of surgery, over a mean follow-up period of 288.9 ± 350.4 days (range, 5–1841), 28.85% (15/52) of eyes were in stage B, 28.85% (15/52) were in stage C, and 42.3% (22/52) were in stage D. There was a statistically significant association between increasing stage at baseline and longer duration of macular hole symptoms (<em>P</em> = 0.032) and worse visual acuity at baseline (<em>P</em> < 0.001). Additionally, patients presenting with stages B and C at the time point closest to surgery had better visual acuity outcomes 3 months postoperatively than those with stage D (<em>P</em> = 0.04).</div></div><div><h3>Conclusions</h3><div>This SD-OCT staging system describes the sequential in vivo morphologic changes after FTMH formation, providing a novel imaging biomarker.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 4","pages":"Pages 305-313"},"PeriodicalIF":4.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-01DOI: 10.1016/j.oret.2025.03.023
Jordana G Fein, Priya S Vakharia, A Paul Chous, Rutvi Desai, Fabiana Q Silva, Kimberly Reed, Alyson J Berliner, Robert Vitti, Charles C Wykoff
In this post hoc analysis of the CANDELA trial, eyes with neovascular age-related macular degeneration treated with aflibercept 8 mg achieved improved anatomic and visual outcomes, suggesting therapeutic benefit compared with aflibercept 2 mg.
{"title":"Clinical Outcomes in nAMD with Aflibercept 8 mg in the Phase 2 CANDELA Study.","authors":"Jordana G Fein, Priya S Vakharia, A Paul Chous, Rutvi Desai, Fabiana Q Silva, Kimberly Reed, Alyson J Berliner, Robert Vitti, Charles C Wykoff","doi":"10.1016/j.oret.2025.03.023","DOIUrl":"https://doi.org/10.1016/j.oret.2025.03.023","url":null,"abstract":"<p><p>In this post hoc analysis of the CANDELA trial, eyes with neovascular age-related macular degeneration treated with aflibercept 8 mg achieved improved anatomic and visual outcomes, suggesting therapeutic benefit compared with aflibercept 2 mg.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143780710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-01DOI: 10.1016/j.oret.2024.10.017
Nida Wongchaisuwat MD , Jie Wang PhD , Elizabeth S. White MS , Thomas S. Hwang MD , Yali Jia PhD , Steven T. Bailey MD
Purpose
To test the diagnostic performance of an artificial intelligence algorithm for detecting and segmenting macular neovascularization (MNV) with OCT and OCT angiography (OCTA) in eyes with macular edema from various diagnoses.
Design
Prospective cross-sectional study.
Participants
Study participants with macular edema due to either treatment-naïve exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO).
Methods
Study participants were imaged with macular 3 × 3–mm and 6 × 6–mm spectral-domain OCTA. Eyes with exudative AMD were required to have MNV in the central 3 × 3–mm area. A previously developed hybrid multitask convolutional neural network for MNV detection (aiMNV), and segmentation was applied to all images, regardless of image quality.
Main Outcome Measures
Sensitivity, specificity, positive predictive value, and negative predictive value of detecting MNV and intersection over union (IoU) score and F1 score for segmentation.
Results
Of 114 eyes from 112 study participants, 56 eyes had MNV due to exudative AMD and 58 eyes with macular edema due to either DME or RVO. The 3 × 3–mm OCTA scans with aiMNV detected MNV with 96.4% sensitivity, 98.3% specificity, 98.2% positive predictive value, and 96.6% negative predictive value. For segmentation, the average IoU score was 0.947, and the F1 score was 0.973. The 6 × 6–mm scans performed well; however, sensitivity for MNV detection was lower than 3 × 3–mm scans due to lower scan sampling density.
Conclusions
This novel aiMNV algorithm can accurately detect and segment MNV in eyes with exudative AMD from a control group of eyes that present with macular edema from either DME or RVO. Higher scan sampling density improved the aiMNV sensitivity for MNV detection.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Detection of Macular Neovascularization in Eyes Presenting with Macular Edema using OCT Angiography and a Deep Learning Model","authors":"Nida Wongchaisuwat MD , Jie Wang PhD , Elizabeth S. White MS , Thomas S. Hwang MD , Yali Jia PhD , Steven T. Bailey MD","doi":"10.1016/j.oret.2024.10.017","DOIUrl":"10.1016/j.oret.2024.10.017","url":null,"abstract":"<div><h3>Purpose</h3><div>To test the diagnostic performance of an artificial intelligence algorithm for detecting and segmenting macular neovascularization (MNV) with OCT and OCT angiography (OCTA) in eyes with macular edema from various diagnoses.</div></div><div><h3>Design</h3><div>Prospective cross-sectional study.</div></div><div><h3>Participants</h3><div>Study participants with macular edema due to either treatment-naïve exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or retinal vein occlusion (RVO).</div></div><div><h3>Methods</h3><div>Study participants were imaged with macular 3 × 3–mm and 6 × 6–mm spectral-domain OCTA. Eyes with exudative AMD were required to have MNV in the central 3 × 3–mm area. A previously developed hybrid multitask convolutional neural network for MNV detection (aiMNV), and segmentation was applied to all images, regardless of image quality.</div></div><div><h3>Main Outcome Measures</h3><div>Sensitivity, specificity, positive predictive value, and negative predictive value of detecting MNV and intersection over union (IoU) score and F1 score for segmentation.</div></div><div><h3>Results</h3><div>Of 114 eyes from 112 study participants, 56 eyes had MNV due to exudative AMD and 58 eyes with macular edema due to either DME or RVO. The 3 × 3–mm OCTA scans with aiMNV detected MNV with 96.4% sensitivity, 98.3% specificity, 98.2% positive predictive value, and 96.6% negative predictive value. For segmentation, the average IoU score was 0.947, and the F1 score was 0.973. The 6 × 6–mm scans performed well; however, sensitivity for MNV detection was lower than 3 × 3–mm scans due to lower scan sampling density.</div></div><div><h3>Conclusions</h3><div>This novel aiMNV algorithm can accurately detect and segment MNV in eyes with exudative AMD from a control group of eyes that present with macular edema from either DME or RVO. Higher scan sampling density improved the aiMNV sensitivity for MNV detection.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 4","pages":"Pages 378-385"},"PeriodicalIF":4.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-01DOI: 10.1016/j.oret.2024.10.015
Veeral S. Sheth MD , Nancy M. Holekamp MD , Arshad M. Khanani MD, FASRS , Aleksandra Rachitskaya MD, FASRS , Steven Blotner MS , Shamika Gune MD , Dominic Heinrich MD , Katie F. Maass PhD , Usha Chakravarthy MD, PhD
Purpose
To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.
Design
Post hoc analyses of phase 3 Archway trial (NCT03677934).
Participants
Adults with nAMD responsive to anti-VEGF therapy.
Intervention
Four hundred eighteen patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks.
Outcomes
Proportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1 mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA.
Results
Four hundred fifteen eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96, respectively. BCVA changes from baseline to week 96 were −1.1 letters with the PDS versus −1.4 with monthly ranibizumab in eyes with SRF/IRF, and −1.9 versus −1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were −2.1 with the PDS versus −6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] vs. 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were −2.5 versus −2.6 (mean BCVA at 96 weeks 72.7 [20/35] vs. 71.5 [20/38]).
Conclusions
Port Delivery System with ranibizumab Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections","authors":"Veeral S. Sheth MD , Nancy M. Holekamp MD , Arshad M. Khanani MD, FASRS , Aleksandra Rachitskaya MD, FASRS , Steven Blotner MS , Shamika Gune MD , Dominic Heinrich MD , Katie F. Maass PhD , Usha Chakravarthy MD, PhD","doi":"10.1016/j.oret.2024.10.015","DOIUrl":"10.1016/j.oret.2024.10.015","url":null,"abstract":"<div><h3>Purpose</h3><div>To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.</div></div><div><h3>Design</h3><div>Post hoc analyses of phase 3 Archway trial (NCT03677934).</div></div><div><h3>Participants</h3><div>Adults with nAMD responsive to anti-VEGF therapy.</div></div><div><h3>Intervention</h3><div>Four hundred eighteen patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks.</div></div><div><h3>Outcomes</h3><div>Proportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1 mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA.</div></div><div><h3>Results</h3><div>Four hundred fifteen eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96, respectively. BCVA changes from baseline to week 96 were −1.1 letters with the PDS versus −1.4 with monthly ranibizumab in eyes with SRF/IRF, and −1.9 versus −1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were −2.1 with the PDS versus −6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] vs. 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were −2.5 versus −2.6 (mean BCVA at 96 weeks 72.7 [20/35] vs. 71.5 [20/38]).</div></div><div><h3>Conclusions</h3><div>Port Delivery System with ranibizumab Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 4","pages":"Pages 330-342"},"PeriodicalIF":4.4,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-01DOI: 10.1016/j.oret.2024.12.010
Noah A. Brown MD , Daniel A. Balikov MD, PhD , Daniel Boyer MD, PhD , Bryan L. Betz PhD , Amir Behdad MD , Thérèse M. Sassalos MD , Hakan Demirci MD , Rajesh C. Rao MD
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