Srikanta Kumar Padhy, Deepika C Parameswarappa, Sumant Sharma, Tapas Ranjan Padhi, Subhadra Jalali, Brijesh Takkar, Raja Narayanan
{"title":"Widefield Retinal Imaging in Gyrate Atrophy: Correlation of Structural, Biochemical, and Functional Characteristics.","authors":"Srikanta Kumar Padhy, Deepika C Parameswarappa, Sumant Sharma, Tapas Ranjan Padhi, Subhadra Jalali, Brijesh Takkar, Raja Narayanan","doi":"10.1016/j.oret.2024.10.016","DOIUrl":"10.1016/j.oret.2024.10.016","url":null,"abstract":"<p><strong>Objective: </strong>To profile a cohort of gyrate atrophy patients classified by widefield retinal imaging and correlate the structural, biochemical, and functional characteristics.</p><p><strong>Design: </strong>Retrospective observational cohort study.</p><p><strong>Participants: </strong>Sixty-five patients (129 eyes) with gyrate atrophy.</p><p><strong>Methods: </strong>Data of participants with a diagnosis of gyrate atrophy were retrieved from their electronic medical records (January 2015 to December 2023). Retinal involvement was classified into 3 zones using widefield retinal images. Zone 3 had atrophic patches in the area anterior to the equator; zone 2 had involvement limited to the arcades but posterior to the equator; zone 1 had involvement within the vascular arcades and/or peripapillary region, with or without any other zone involvement. Macular assessment was performed using swept-source OCT (n = 104). Flash electroretinogram (ERG) was performed in 40 eyes. Serum ornithine levels (n = 35) were measured, and genetic analysis was conducted (n = 18).</p><p><strong>Main outcome measures: </strong>Demography, patient profile, zone of retina involved, macular features, and serum ornithine levels.</p><p><strong>Results: </strong>The average age at presentation was 26.4 (range, 5-67) years; the majority were male. Nyctalopia (n = 35, 53.8%) and blurred vision (n = 29, 44.6%) were the most common symptoms. Positive family history was reported in 32.3% of patients. Most eyes were myopic (69.8% <-3 diopters). Posterior subcapsular cataracts were documented in 36.4% of eyes. The highest frequency of retinal area affected was zone 1 (57.14%), followed by zone 2 (33.33%) and zone 3 (9.52%), correlating with the age at presentation. Foveoschisis was observed in 57.7% of eyes, with a higher prevalence in eyes with zone 1 disease. Elevated serum ornithine levels (>163 μmol/L) were found in 77.14% of patients. The ERG showed nonrecordable (n = 32) or severely reduced (n = 8) responses in scotopic and photopic phases. Genetic analysis of 18 patients identified mutations in the OAT gene, including a novel missense variant (c.290T>C).</p><p><strong>Conclusions: </strong>This large cohort of patients with gyrate atrophy revealed symmetrical involvement, predominantly in zone 1. Most patients presented between the first and third decades, experienced nyctalopia, vision reduction, early posterior subcapsular cataracts, and varying degrees of myopia. Zone 1 involvement was strongly associated with foveoschisis and visual compromise.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505232","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}
Min Seok Kim, Seonghee Nam, Si Un Lee, Sang Jun Park, Se Joon Woo, Jeongwoo Lee, Kwangsic Joo
{"title":"Moyamoya Disease Increased the Risk of Retinal Vascular Occlusion: A Nationwide Cohort Study in Korea.","authors":"Min Seok Kim, Seonghee Nam, Si Un Lee, Sang Jun Park, Se Joon Woo, Jeongwoo Lee, Kwangsic Joo","doi":"10.1016/j.oret.2024.10.013","DOIUrl":"10.1016/j.oret.2024.10.013","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate the risk of retinal vascular occlusion in patients with Moyamoya disease (MMD).</p><p><strong>Design: </strong>Retrospective, longitudinal cohort study using the Korean National Health Insurance Service database.</p><p><strong>Participants: </strong>Newly diagnosed MMD patients (n = 34 627), who were diagnosed between 2004 and 2022, and their propensity score matched controls (n = 136 945) were included.</p><p><strong>Methods: </strong>We identified retinal vascular occlusion events using diagnostic codes for central retinal artery occlusion, other retinal artery occlusion, and retinal vein occlusion. After a washout period from 2002 to 2003, information on the diagnosis of retinal vascular occlusion was extracted in both MMD and control group during the follow-up period. The association between MMD and the risk of subsequent retinal vascular occlusion was investigated using a time-dependent Cox proportional hazard model and Kaplan-Meier survival analysis with log-rank test adjusted for age, sex, and comorbidities.</p><p><strong>Main outcome measures: </strong>Hazard ratios (HRs) and 95% confidence intervals (CIs) for retinal vascular occlusion development according to the MMD.</p><p><strong>Results: </strong>Moyamoya disease was associated with an increased risk of subsequent retinal vascular occlusion even after adjusting for confounding variables (HR, 1.22; 95% CI, 1.09-1.36). Among the subtypes of retinal vascular occlusion, central retinal artery occlusion showed a highest HR (2.23; 95% CI, 1.35-3.7). Incidence probability of retinal vascular occlusion was significantly higher among MMD patients than controls (P < 0.001, log-rank test).</p><p><strong>Conclusions: </strong>In this nationwide population-based cohort study, patients with MMD in Korea had an elevated risk of retinal vascular occlusion, suggesting that the MMD is one of the risk factors for retinal vascular occlusion.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505230","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}
Wendy Yangyiran Xie, Zainab Rustam, Diep Tran, Dingfen Han, Mozhdeh Bahrainian, Roomasa Channa, Cindy X Cai
{"title":"Association of Neighborhood Socioeconomic Disadvantage with Proliferative Diabetic Retinopathy.","authors":"Wendy Yangyiran Xie, Zainab Rustam, Diep Tran, Dingfen Han, Mozhdeh Bahrainian, Roomasa Channa, Cindy X Cai","doi":"10.1016/j.oret.2024.10.012","DOIUrl":"10.1016/j.oret.2024.10.012","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the association between neighborhood socioeconomic deprivation, distance from ophthalmology clinics, and diagnosis of proliferative diabetic retinopathy (PDR).</p><p><strong>Design: </strong>Retrospective cohort study.</p><p><strong>Participants: </strong>Adult patients (≥18 years) with diabetes mellitus at Johns Hopkins Hospital and University of Wisconsin-Madison.</p><p><strong>Methods: </strong>Patient addresses were geocoded and the block group was linked to the 2021 national Area Deprivation Index (ADI). Area Deprivation Index was divided into quartiles, with higher quartiles indicating greater socioeconomic disadvantage. The distance between patient's residence and ophthalmology clinics was calculated. Multivariable logistic regression models were used to analyze the association between ADI quartile, distance from clinic, and PDR, adjusted for demographics and insurance status. The interaction between ADI and distance was tested.</p><p><strong>Main outcome measures: </strong>Diagnosis of PDR.</p><p><strong>Results: </strong>A total of 73 618 patients were included. A significant interaction was observed between ADI quartile and distance from ophthalmology clinics (P < 0.001). Among patients residing within 8 miles of clinics, those in higher ADI quartiles had increased odds of PDR compared with those in ADI Q1 (Q2: odds ratio [OR], 1.36; 95% confidence interval [CI], 1.12-1.65; Q3: OR, 1.79; 95% CI, 1.46-2.19; Q4: OR, 2.60; 95% CI, 2.09-3.25; P < 0.001 for trend). Conversely, for patients living more than 8 miles from clinics, the odds of PDR were similar across ADI quartiles (Q1: OR, 0.85; 95% CI, 0.73-0.98; Q2: OR, 1.02; 95% CI, 0.87-1.12; Q3: OR, 1.08; 95% CI, 0.90-1.30). However, patients in all ADI quartiles more than 8 miles had greater odds of PDR compared with those in the same ADI quartile within 8 miles (OR, 3.15; 95% CI, 2.61-3.80; OR, 1.97; 95% CI, 1.71-2.27; OR, 1.79; 95% CI, 1.51-2.12; and OR, 1.31; 95% CI, 1.07-1.61 in ADI Q1-Q4, respectively).</p><p><strong>Conclusions: </strong>Patients living in neighborhoods with greater socioeconomic disadvantage and farther from ophthalmology clinics have greater odds of PDR. These findings suggest the potential utility of targeted interventions in socioeconomically deprived and distant areas to reduce PDR-related blindness.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471482","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}
Tianyu Liu, Margaret Runner, Tamer H Mahmoud, Antonio Capone, Kimberly A Drenser, Sandeep Randhawa, George A Williams, Lisa J Faia
{"title":"A Modified Intravitreal Methotrexate Protocol for the Prevention of Proliferative Vitreoretinopathy after Silicone Oil Removal.","authors":"Tianyu Liu, Margaret Runner, Tamer H Mahmoud, Antonio Capone, Kimberly A Drenser, Sandeep Randhawa, George A Williams, Lisa J Faia","doi":"10.1016/j.oret.2024.10.006","DOIUrl":"10.1016/j.oret.2024.10.006","url":null,"abstract":"<p><strong>Objective: </strong>To utilize a modified intravitreal (IVT) methotrexate (MTX) protocol for the prevention of proliferative vitreoretinopathy (PVR) after silicone oil (SO) removal (SOR).</p><p><strong>Design: </strong>Single-center nonrandomized retrospective comparative case series.</p><p><strong>Subjects: </strong>Eyes with grade C PVR who underwent retinal detachment (RD) repair and SO placement between 2019 and 2022 with ≥6 months of follow-up after SOR. A control group of age- and sex-matched eyes was included.</p><p><strong>Methods: </strong>Eyes were treated with 1 of 2 MTX protocols. Eyes in Group 1 received 6 IVT MTX injections after SO placement and another 6 IVT MTX injections after SOR. Eyes in Group 2 received 6 IVT MTX after SO placement only. Each series of 6 IVT MTX injections (400 μg/0.1 mL) consisted of 3 injections every 2 weeks followed by 3 injections every 4 weeks.</p><p><strong>Main outcome measures: </strong>The primary outcome was the retinal attachment rate at 6 months post-SOR without redetachment or reoperation. Secondary outcomes included change in visual acuity and rates of complications after SOR.</p><p><strong>Results: </strong>Fifty-two eyes of 52 patients (13 Group 1, 13 Group 2, 26 control) (mean age 59.8 years, 80.8% male) were included with a mean follow-up of 31.0 months. In aggregate, Group 1 and Group 2 eyes received a median (interquartile range [IQR]) of 6 (5.25, 7) IVT MTX injections pre-SOR; eyes in Group 1 received a median (IQR) of 5 (3, 6) IVT MTX injections post-SOR. Twelve (92.3%) Group 1 eyes, 11 (84.6%) Group 2 eyes, and 21 (80.8%) control eyes had primary retinal attachment at 6 months post-SOR (P > 0.05). Visual acuity outcomes did not significantly differ between groups (P > 0.05). Rates of epiretinal membrane (ERM) and cystoid macular edema (CME) were significantly lower in Group 1 eyes (7.7% and 15.4%) compared with Group 2 (53.8% and 92.3%) and control (44.3% and 65.4%) eyes, respectively (P < 0.05).</p><p><strong>Conclusions: </strong>The use of IVT MTX injections in eyes with PVR undergoing RD repair was associated with a high rate of primary retinal attachment after SOR. Eyes that received IVT MTX injections after SOR had significantly lower rates of ERM and CME than eyes that did not.</p><p><strong>Financial disclosure(s): </strong>The author(s) have no proprietary or commercial interest in any materials discussed in this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":5.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471481","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}
Ankur Nahar, Dean Eliott, Robert L Avery, Jose Pulido, Ralph C Eagle, Jacqueline R Carrasco, Courtney Crawford, Tatyana Milman, Anna M Stagner
{"title":"Retinal Vasculopathy and Choroiditis after Pegcetacoplan Injection: Clinicopathologic Support for a Drug Hypersensitivity Reaction.","authors":"Ankur Nahar, Dean Eliott, Robert L Avery, Jose Pulido, Ralph C Eagle, Jacqueline R Carrasco, Courtney Crawford, Tatyana Milman, Anna M Stagner","doi":"10.1016/j.oret.2024.10.005","DOIUrl":"10.1016/j.oret.2024.10.005","url":null,"abstract":"<p><strong>Purpose: </strong>To report the detailed histopathology of 2 enucleated eyes from 2 patients who developed severe visual loss associated with retinal hemorrhages, vessel sheathing, and vascular nonperfusion after administration of an initial dose of intravitreal pegcetacoplan, and propose, with supportive histopathology, the pathogenesis of the clinical syndrome previously termed hemorrhagic occlusive retinal vasculitis.</p><p><strong>Design: </strong>Case series.</p><p><strong>Subjects: </strong>Two enucleated eyes from 2 patients treated with intravitreal pegcetacoplan.</p><p><strong>Methods: </strong>Retrospective, multicenter, consecutive clinical-pathologic analysis.</p><p><strong>Main outcome measures: </strong>Histopathologic review and immunophenotypic characterization.</p><p><strong>Results: </strong>Both patients presented with inflammation and significant vision loss 9 days after the initial injection of pegcetacoplan with no subsequent improvement and underwent enucleation for pain control. Histologic examination of the enucleated eyes (patient 1 at 4 months postinjection and patient 2 at 40 days) revealed extensive vascular thrombosis, retinal hemorrhages and necrosis, and a dense inflammatory infiltrate in the uvea and, variably, the optic nerve, episclera, and muscle tendons composed of predominantly of T cells, macrophages, and eosinophils. Notably, the inflammatory infiltrate was absent from the retina. In addition, 1 eye demonstrated multiple foci of glomerular-like vascular proliferations in the uveal tract and thrombosis with focal recanalization of vessels in the optic nerve.</p><p><strong>Conclusions: </strong>Drug-induced, immune-mediated, retinal vasculopathy and choroiditis (DIRVAC) is a rare complication after pegcetacoplan injection. Although some limitations arise in interpretation of histopathologic findings because of compensatory changes in the eyes over time (before enucleation), the authors propose that the combined clinical, histopathologic, and immunohistochemical findings suggest a mixed-type, delayed hypersensitivity reaction as the mechanism of initial injury.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471485","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}
Charles C Wykoff, Diana V Do, W Lloyd Clark, David S Boyer, Dilsher S Dhoot, Dennis M Marcus, Robert Vitti, Alyson J Berliner, Kimberly Reed, Yenchieh Cheng, Hadi Moini, David M Brown
{"title":"Longitudinal Changes in Diabetic Retinopathy Severity: Learnings from PANORAMA.","authors":"Charles C Wykoff, Diana V Do, W Lloyd Clark, David S Boyer, Dilsher S Dhoot, Dennis M Marcus, Robert Vitti, Alyson J Berliner, Kimberly Reed, Yenchieh Cheng, Hadi Moini, David M Brown","doi":"10.1016/j.oret.2024.10.007","DOIUrl":"10.1016/j.oret.2024.10.007","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471484","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}
Laura Sánchez-Vela, Claudia García-Arumí Fusté, Marta Castany-Aregall, Olaia Subirà-González, Diego Ruiz-Casas, Pablo de-Arriba-Palomero, José García-Arumí
{"title":"Reverse Pupillary Block after Implantation of a Sutureless Scleral Fixation Carlevale Intraocular Lens.","authors":"Laura Sánchez-Vela, Claudia García-Arumí Fusté, Marta Castany-Aregall, Olaia Subirà-González, Diego Ruiz-Casas, Pablo de-Arriba-Palomero, José García-Arumí","doi":"10.1016/j.oret.2024.10.004","DOIUrl":"10.1016/j.oret.2024.10.004","url":null,"abstract":"<p><strong>Purpose: </strong>To describe the incidence, complications and management of reverse pupillary block (RPB) after implantation of Carlevale intraocular lens (IOL).</p><p><strong>Design: </strong>Multicenter, retrospective, cross-sectional study.</p><p><strong>Participants: </strong>Of a sample of 128 patients that had undergone Carlevale IOL implantation, 19 patients were found to present RPB.</p><p><strong>Methods: </strong>Nineteen patients with RPB after Carlevale IOL implantation were evaluated and treated with laser peripheral iridotomy (LPI).</p><p><strong>Main outcome measures: </strong>Demographic data (age and gender), data on preexisting medication, axial length (Zeiss IOLMaster 500 and Zeiss IOLMaster 700), presence of pseudoexfoliation material, presence of RPB (anterior segment swept-source SS-OCT Anterion, Heidelberg Engineering), presence of macular edema (Irvine Gass syndrome, OCT Spectralis, Heidelberg Engineering), anterior chamber depth (ACD) before and after LPI, best-corrected visual acuity (BCVA) before and after LPI, and intraocular pressure (IOP) before and after LPI were analyzed.</p><p><strong>Results: </strong>An incidence of RPB of 14.8% was found. The prevalence of pseudoexfoliation syndrome was 21.1%, and 42.1% of patients presented an axial length >24.00 mm. Mean pre-LPI ACD was 4.78 ± 0.465 mm and post-LPI ACD was 4.23 ± 0.404 mm, a statistically significant increase of 0.54 mm (P < 0.001; 95% confidence interval, 0.26-0.83) of ACD was observed. There were no differences between pre- and post-LPI BCVA. Pre-LPI IOP was 17.10 (range, 12-34) mmHg and post-LPI IOP was 14.47 (range, 10-21) mmHg, (P = 0.391). Cystic macular edema (Irvine Gass) was identified in 4 of 19 patients, reporting an incidence of 21.1% in RPB cases.</p><p><strong>Conclusions: </strong>Reverse pupillary block is a relatively common complication after Carlevale lens implantation, which may be associated with an increase of macular edema incidence but does not clearly correlate an increase of IOP. Our hypothesis is that indentation of the sclera induces a posterior rotation of the peripheral iris, causing RPB. Our results encourage looking over the Carlevale IOL implantation technique to consider a routinely intraoperative surgical peripheral iridotomy to avoid RPB and its further complications.</p><p><strong>Financial disclosure(s): </strong>The authors have no proprietary or commercial interest in any materials discussed in this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471494","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}
Jan Hamouz, Agnieszka Nowosielska, Anna Święch-Zubilewicz, Santiago Abengoechea, Kristine Baumane, Attila Vajas, Małgorzata Siewierska, Milan Veselovsky, Miroslav Veith, Ágnes Kerényi, Shobhana Mange, Krishnapada Baidya, Guna Laganovska, Ignasi Jürgens, András Papp, Jignesh Gosai, Jana Štefanickova, Mei Han, Piotr Fryczkowski, Dominik Zalewski, Jing Wang, Wenbin Wei
{"title":"Efficacy and Safety of Ranibizumab Biosimilar QL1205 in Neovascular Age-Related Macular Degeneration: A Phase III Randomized Trial.","authors":"Jan Hamouz, Agnieszka Nowosielska, Anna Święch-Zubilewicz, Santiago Abengoechea, Kristine Baumane, Attila Vajas, Małgorzata Siewierska, Milan Veselovsky, Miroslav Veith, Ágnes Kerényi, Shobhana Mange, Krishnapada Baidya, Guna Laganovska, Ignasi Jürgens, András Papp, Jignesh Gosai, Jana Štefanickova, Mei Han, Piotr Fryczkowski, Dominik Zalewski, Jing Wang, Wenbin Wei","doi":"10.1016/j.oret.2024.10.001","DOIUrl":"10.1016/j.oret.2024.10.001","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to demonstrate the clinical equivalence of biosimilar QL1205 and reference ranibizumab, Lucentis, in patients with neovascular age-related macular degeneration (nAMD).</p><p><strong>Design: </strong>This was a multicenter, double-masked, randomized, controlled phase III trial.</p><p><strong>Participants: </strong>Treatment-naive patients with active nAMD were randomly assigned to receive QL1205 or reference ranibizumab.</p><p><strong>Methods: </strong>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.</p><p><strong>Main outcome measures: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-10-09","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}