Ophthalmology. Retina最新文献

{"title":"End-Stage PRPH2-associated Retinopathy Presenting with Macular Caldera.","authors":"Andrea Trinco, Giovanni Staurenghi, Francesco Romano","doi":"10.1016/j.oret.2024.10.024","DOIUrl":"https://doi.org/10.1016/j.oret.2024.10.024","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142801931","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}

{"title":"Influence of Common Medications on Diabetic Macular Edema in Type 2 Diabetes Mellitus.","authors":"Jawad Muayad, Asad Loya, Zain S Hussain, Debora H Lee, Muhammad Z Chauhan, Andrew G Lee, Asadolah Movahedan, Sami S Dahr","doi":"10.1016/j.oret.2024.12.006","DOIUrl":"10.1016/j.oret.2024.12.006","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to assess the impact of systemic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), fenofibrates, thiazolidinediones (TZDs), and calcium channel blockers (CCBs), on the risk of developing diabetic macular edema (DME) in patients with type 2 diabetes mellitus (T2DM).</p><p><strong>Design: </strong>A retrospective cohort study was conducted using electronic medical records (EMR) data from the TriNetX health research network, covering a period from October 2004 to 2024.</p><p><strong>Participants: </strong>The study population comprised patients diagnosed with T2DM who were newly initiated on GLP-1 RAs, fenofibrates, TZDs, or CCBs. Propensity score matched (PSM) controls were patients with T2DM who did not receive these medications within the same timeframe.</p><p><strong>Methods: </strong>Patients were observed for 1 to 2 years postmedication initiation to monitor the development of DME. The study used 1:1 propensity score matching to adjust for baseline characteristics and comorbidities.</p><p><strong>Main outcome measures: </strong>The primary outcome measure was the incidence rate of DME within the 2-year follow-up period. Hazard ratios (HRs) with 95% confidence interval (CI) were calculated to compare the risk of DME between treatment and control groups.</p><p><strong>Results: </strong>After PSM, the study analyzed data from 107 193 patients in the CCB cohort, 76 583 in the GLP-1 agonists cohort, 25 657 in the TZDs cohort, and 18 606 in the fenofibrates cohort. Calcium channel blocker-treated patients demonstrated a higher risk of DME development compared with controls (HR: 1.66, 95% CI: 1.54-1.78). In contrast, GLP-1 RA-treated patients showed a decreased risk of DME (HR: 0.77, 95% CI: 0.70-0.85), as did fenofibrate-treated patients (HR: 0.83, 95% CI: 0.68-0.98). No significant difference in DME risk was observed in the TZDs cohort (HR: 1.08, 95% CI: 0.94-1.25).</p><p><strong>Conclusions: </strong>Patients on GLP-1 RAs and fenofibrates experienced a lower risk of DME diagnosis, suggesting a protective effect against DME development in patients with T2DM, whereas those on CCBs experienced an increased risk. These findings suggest that systemic medications may significantly influence DME outcomes, warranting further investigation into their effects on retinal health.</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":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142792160","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}

{"title":"Unusual Posterior Atrophy from Persistent Fetal Vasculature-associated Peripapillary Retinoschisis","authors":"Ryan S. Meshkin MD,&nbsp;Sandra Hoyek MD,&nbsp;Nimesh A. Patel MD","doi":"10.1016/j.oret.2024.05.012","DOIUrl":"10.1016/j.oret.2024.05.012","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"8 12","pages":"Page e52"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141492904","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}

{"title":"Retinal Characteristics of Female Choroideremia Carriers","authors":"Sena A. Gocuk DOptom, MPhil ,&nbsp;Thomas L. Edwards PhD, FRANZCO ,&nbsp;Jasleen K. Jolly MSc, PhD ,&nbsp;Myra B. McGuinness MBioStat, PhD ,&nbsp;Robert E. MacLaren MBChB, DPhil ,&nbsp;Fred K. Chen MBBS, PhD ,&nbsp;Laura J. Taylor BSci (Hons) ,&nbsp;Terri L. McLaren BSc ,&nbsp;Tina M. Lamey PhD ,&nbsp;Jennifer A. Thompson PhD ,&nbsp;Lauren N. Ayton Boptom, PhD","doi":"10.1016/j.oret.2024.06.011","DOIUrl":"10.1016/j.oret.2024.06.011","url":null,"abstract":"<div><h3>Purpose</h3><div>To describe visual function and retinal features of female carriers of choroideremia (CHM), using multimodal imaging and microperimetry.</div></div><div><h3>Design</h3><div>Cross-sectional cohort study.</div></div><div><h3>Participants and Controls</h3><div>Choroideremia carriers seen in Australia (Melbourne or Perth) or the United Kingdom (Oxford or Cambridge) between 2012 and 2023. Healthy age-matched controls seen in Melbourne, Australia, between 2022 and 2023.</div></div><div><h3>Methods</h3><div>Participants had visual acuity, fundus-tracked microperimetry, OCT, and fundus autofluorescence imaging performed. Choroideremia carriers were either genetically or clinically confirmed (i.e., obligate carriers). Choroideremia carriers were grouped according to their retinal phenotype and compared with healthy controls. Statistical analyses were performed on StataBE (v18.0).</div></div><div><h3>Main Outcome Measures</h3><div>Best-corrected visual acuity (BCVA), low-luminance visual acuity (LLVA), average retinal sensitivity, volume of macular hill of vision (HoV), inner retinal thickness, and photoreceptor complex (PRC) thickness.</div></div><div><h3>Results</h3><div>Eighty-six eyes of 43 CHM carriers and 60 eyes of 30 healthy controls were examined using multimodal imaging and microperimetry. Median age was 54 and 48.5 years for CHM carriers and controls, respectively (<em>P</em> = 0.18). Most CHM carriers (86%) were genetically confirmed. Choroideremia carriers and controls had strong intereye correlation between eyes for BCVA and average retinal sensitivity (<em>P</em> &lt; 0.001). Low-luminance visual acuity and macular HoV tests were sensitive tests to detect changes in CHM carriers with mild phenotypes (i.e., fine and coarse). Choroideremia carriers with geographic or male-pattern phenotypes had reduced BCVA, LLVA, retinal sensitivity, and retinal thinning, compared with healthy controls. Retinal thickening of the inner retina was observed in the central 1°, despite generalized thinning of the PRC in the central 7°, indicating retinal remodeling in CHM carriers, compared with controls. There were no genotype–phenotype correlations observed.</div></div><div><h3>Conclusions</h3><div>Female carriers of CHM with severe retinal phenotypes (i.e., geographic or male pattern) have significantly decreased visual function and retinal structural changes when compared with age-matched controls and those carriers with milder phenotypes. Low-luminance visual acuity and volumetric measures of the macular HoV were found to be the most sensitive functional tests to detect milder retinal disease (fine and coarse phenotypes) in CHM carriers.</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":"8 12","pages":"Pages 1200-1210"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141469809","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}

{"title":"Vitelliform Lesions Associated with Leptochoroid and Pseudodrusen","authors":"Serena Fragiotta MD, PhD ,&nbsp;Mariacristina Parravano MD ,&nbsp;Giulia Corradetti MD ,&nbsp;Elodie Bousquet MD ,&nbsp;Maria Sole Polito MD ,&nbsp;Riccardo Sacconi MD, PhD ,&nbsp;Vittorio Capuano MD ,&nbsp;Eliana Costanzo MD ,&nbsp;Beatrice Tombolini MD ,&nbsp;Eric H. Souied MD, PhD ,&nbsp;Francesco Bandello MD ,&nbsp;SriniVas R. Sadda MD ,&nbsp;David Sarraf MD ,&nbsp;Giuseppe Querques MD, PhD","doi":"10.1016/j.oret.2024.07.003","DOIUrl":"10.1016/j.oret.2024.07.003","url":null,"abstract":"<div><h3>Objective</h3><div>To characterize clinical and prognostic implications of leptovitelliform maculopathy (LVM), a distinctive phenotype of vitelliform lesion characterized by the coexistence of subretinal drusenoid deposits (SDDs) and leptochoroid.</div></div><div><h3>Design</h3><div>Retrospective, cohort study.</div></div><div><h3>Subjects</h3><div>The study compared patients affected by LVM with cohorts displaying a similar phenotypic spectrum. This included patients with acquired vitelliform lesions (AVLs) and those with SDDs alone.</div></div><div><h3>Methods</h3><div>A total of 60 eyes of 60 patients were included, of which 20 eyes had LVM, 20 eyes had AVLs, and the remaining had SDDs. Patients &gt;50 years of age with complete medical records and multimodal imaging for ≥6 months of follow-up, including color fundus photography or MultiColor imaging, OCT, fundus autofluorescence, and OCT angiography were included.</div></div><div><h3>Main Outcome Measures</h3><div>Choroidal vascularity index (CVI); proportion of late-stage complications (macular neovascularization, atrophy).</div></div><div><h3>Results</h3><div>The AVL subgroup exhibited a significantly higher CVI compared with both LVM (<em>P</em> = 0.001) and SDD subgroups (<em>P</em> &lt; 0.001). The proportion of late-stage complications significantly differed among subgroups (chi-square = 7.5, <em>P</em> = 0.02). Eyes with LVM presented the greatest proportion of complications (55%) after a mean of 29.3 months, whereas the remaining eyes presented a similar proportion of complications, including 20% in the AVL group after 27.6 months and 20% in the SDD group after 36.9 months. Kaplan–Meier estimates of survival demonstrated a significant difference in atrophy development between groups (<em>P</em> &lt; 0.001), with a median survival of 3.9 years for the LVM group and 7.1 years for controls. The presence of LVM correlated with a fourfold increase in the likelihood of developing complications.</div></div><div><h3>Conclusions</h3><div>Leptovitelliform maculopathy, characterized by the association of vitelliform lesions with SDDs and leptochoroid, represents a distinct clinical phenotype in the broader spectrum of vitelliform lesions. The importance of a clinical distinction for these lesions is crucial due to their higher propensity for faster progression and elevated rate of complications, particularly atrophic conversion.</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":"8 12","pages":"Pages 1151-1162"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616910","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}

{"title":"Decreased Macular Choriocapillaris Perfusion Correlates with Contrast Sensitivity Function in Dry Age-Related Macular Degeneration","authors":"Francesco Romano MD ,&nbsp;Filippos Vingopoulos MD ,&nbsp;Melissa Yuan MD ,&nbsp;Xinyi Ding MD ,&nbsp;Mauricio Garcia MS ,&nbsp;Ioanna Ploumi MSc ,&nbsp;Jocelyn Rodriguez MD ,&nbsp;Itika Garg MD ,&nbsp;Jack H. Tracy MS ,&nbsp;Augustine Bannerman BSc ,&nbsp;Hanna Choi MS ,&nbsp;Isabella Stettler MS ,&nbsp;Cade Bennett BSc ,&nbsp;Katherine M. Overbey BSc ,&nbsp;Inês Laìns MD, PhD ,&nbsp;Leo A. Kim MD, PhD ,&nbsp;Demetrios G. Vavvas MD, PhD ,&nbsp;Deeba Husain MD ,&nbsp;Joan W. Miller MD ,&nbsp;John B. Miller MD","doi":"10.1016/j.oret.2024.06.005","DOIUrl":"10.1016/j.oret.2024.06.005","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the relationships between contrast sensitivity (CS), choriocapillaris perfusion, and other structural OCT biomarkers in dry age-related macular degeneration (AMD).</div></div><div><h3>Design</h3><div>Cross-sectional, observational study.</div></div><div><h3>Participants</h3><div>One hundred AMD eyes (22 early, 52 intermediate, and 26 late) from 74 patients and 45 control eyes from 37 age-similar subjects.</div></div><div><h3>Methods</h3><div>All participants had visual acuity (VA) assessment, quantitative CS function (qCSF) testing, macular OCT, and 6 × 6-mm swept-source OCT angiography scans on the same day. OCT volumes were analyzed for subretinal drusenoid deposits and hyporeflective drusen cores, and to measure thickness of the outer nuclear layer. OCT angiography scans were utilized to calculate drusen volume and inner choroid flow deficit percentage (IC-FD%), and to measure the area of choroidal hypertransmission defects (HTDs). Inner choroid flow deficit percentage was measured from a 16-μm thick choriocapillaris slab after compensation and binarization with Phansalkar’s method. Generalized linear mixed-effects models were used to evaluate the associations between functional and structural variables.</div></div><div><h3>Main Outcome Measures</h3><div>To explore the associations between qCSF-measured CS, IC-FD%, and various AMD imaging biomarkers.</div></div><div><h3>Results</h3><div>Age-related macular degeneration exhibited significantly reduced qCSF metrics eyes across all stages compared with controls. Univariate analysis revealed significant associations between various imaging biomarkers, reduced qCSF metrics, and VA in both groups. Multivariate analysis confirmed that higher IC-FD% in the central 5 mm was significantly associated with decreases in all qCSF metrics in AMD eyes (β = −0.74 to −0.25, all <em>P</em> &lt; 0.05), but not with VA (<em>P</em> &gt; 0.05). Outer nuclear layer thickness in the central 3 mm correlated with both VA (β = 2.85, <em>P</em> &lt; 0.001) and several qCSF metrics (β = 0.01–0.90, all <em>P</em> &lt; 0.05), especially in AMD eyes. Further, larger HTD areas were associated with decreased VA (β = −0.89, <em>P</em> &lt; 0.001) and reduced CS at low-intermediate frequencies across AMD stages (β = −0.30 to −0.29, <em>P</em> &lt; 0.001).</div></div><div><h3>Conclusions</h3><div>The significant association between IC-FD% in the central 5 mm and qCSF-measured CS reinforces the hypothesis that decreased macular choriocapillaris perfusion contributes to visual function changes in AMD, which are more pronounced in CS than in VA.</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":"8 12","pages":"Pages 1140-1150"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327723","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}

{"title":"Efficacy and Safety of 0.19-mg Fluocinolone Acetonide Implant in Postoperative Cystoid Macular Edema after Pars Plana Vitrectomy","authors":"Karolina Motloch MD, PhD ,&nbsp;Vincent Soler MD, PhD ,&nbsp;Marie-Noëlle Delyfer MD, PhD ,&nbsp;Vivien Vasseur ,&nbsp;Benjamin Wolff MD ,&nbsp;Mohamad Issa MD ,&nbsp;Corinne Dot MD, PhD ,&nbsp;Hélène Massé MD ,&nbsp;Michel Weber MD, PhD ,&nbsp;Alban Comet MD ,&nbsp;Wolfgang Hitzl PhD ,&nbsp;Frederic Matonti MD, PhD ,&nbsp;Catherine Creuzot-Garcher MD, PhD ,&nbsp;Ramin Tadayoni MD, PhD ,&nbsp;Laurent Kodjikian MD, PhD ,&nbsp;Aude Couturier MD, PhD","doi":"10.1016/j.oret.2024.07.004","DOIUrl":"10.1016/j.oret.2024.07.004","url":null,"abstract":"<div><h3>Purpose</h3><div>To assess the efficacy and safety of 0.19-mg fluocinolone acetonide (FAc) intravitreal implant (Iluvien) in treating chronic postoperative cystoid macular edema (PCME) after pars plana vitrectomy.</div></div><div><h3>Design</h3><div>Retrospective multicentric case series in clinical settings.</div></div><div><h3>Subjects</h3><div>Patients with chronic PCME who underwent vitrectomy in tertiary care centers in France.</div></div><div><h3>Methods</h3><div>Review of charts and OCT scans.</div></div><div><h3>Main Outcome Measures</h3><div>The primary end points were the best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Secondary end points were the intraocular pressure (IOP); proportion of patients maintaining a BCVA ≥20/40; need for additional nonstudy treatment; differences between eyes that underwent a single and multiple surgeries; and OCT biomarkers of better BCVA.</div></div><div><h3>Results</h3><div>Forty-nine eyes of 49 patients with a mean follow-up of 24.5 ± 3.87 months were included. The mean BCVA increased from 0.40 ± 0.26 logarithm of the minimum angle of resolution (logMAR) at baseline to 0.32 ± 0.24 logMAR at month 24 (<em>P</em> = 0.0035). The mean CRT decreased from 409 ± 139 μm at baseline to 340 ± 92 μm at month 24 (<em>P</em> = 0.0001). The mean IOP was 14.0 ± 4 mmHg at baseline and remained stable at 14.03 ± 4.1 mmHg at month 24 (<em>P</em> = 0.99). During the follow-up, the IOP exceeded 21 mmHg in 9 eyes, with one eye requiring cyclophotocoagulation. The BCVA was ≥20/40 in 47% of eyes (95% confidence interval [CI], 34%–61%) at baseline and in 58% of eyes at month 24 (95% CI, 41%–73%). At month 18, the likelihood of achieving a BCVA ≥20/40 was higher in eyes with intact external limiting membrane and ellipsoid zone. Additional dexamethasone (DEX) implant was injected in 14 eyes (28.6%). The treatment burden of 2.45 ± 1.35 DEX implant/y was decreased to 0.57 ± 0.60 DEX implant/y after FAc implantation (<em>P</em> = 0.001).</div></div><div><h3>Conclusions</h3><div>Fluocinolone acetonide implant improved the BCVA, reduced the CRT, and allowed reducing treatment burden in eyes with chronic PCME after vitrectomy. The safety profile was acceptable.</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":"8 12","pages":"Pages 1181-1191"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616908","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}

{"title":"Biosimilar Candidate CT-P42 in Diabetic Macular Edema","authors":"Sebastian Wolf MD, PhD ,&nbsp;Paulo-Eduardo Stanga MD, PhD ,&nbsp;Milan Veselovsky MD ,&nbsp;Miroslav Veith MD, PhD ,&nbsp;Andras Papp MD, PhD ,&nbsp;Shobhana Mange MBBS, MS(Oph) ,&nbsp;Lakshmi Kanta Mondal MBBS, MS(Oph) ,&nbsp;Dominika Romanczak MD ,&nbsp;Ladislav Janco PhD ,&nbsp;Rohan Chauhan MBBS, DO ,&nbsp;Bożena Romanowska-Dixon MD, PhD ,&nbsp;Alena Eremina MD, PhD ,&nbsp;Nataliya Zavgorodnya MD ,&nbsp;Jaroslava Dusova MD, PhD ,&nbsp;Min Sagong MD, PhD ,&nbsp;Sunghyun Kim PhD ,&nbsp;Keumyoung Ahn PhD ,&nbsp;Suyoung Kim RN, BSN ,&nbsp;Youngmin Bae DVM ,&nbsp;Sangmi Lee MS ,&nbsp;David M. Brown MD","doi":"10.1016/j.oret.2024.06.013","DOIUrl":"10.1016/j.oret.2024.06.013","url":null,"abstract":"<div><h3>Objective</h3><div>To demonstrate the therapeutic similarity of CT-P42 compared with reference aflibercept (Eylea) in adult patients with diabetic macular edema (DME).</div></div><div><h3>Design</h3><div>Randomized, active-controlled, double-masked, phase III clinical trial</div></div><div><h3>Participants</h3><div>Patients with a diagnosis of either type 1 or 2 diabetes mellitus with DME involving the center of the macula.</div></div><div><h3>Methods</h3><div>Patients were randomized (1:1) to receive either CT-P42 or reference aflibercept (2 mg/0.05 ml) by intravitreal injection every 4 weeks (5 doses), then every 8 weeks (4 doses), in the main study period. Results up to week 24 are reported herein.</div></div><div><h3>Main Outcome Measures</h3><div>The primary end point was mean change from baseline at week 8 in best-corrected visual acuity (BCVA) using the ETDRS chart. Equivalence between CT-P42 and reference aflibercept was to be concluded if the 2-sided 95% confidence interval (CI) (global assumptions) and 2-sided 90% CI (United States Food and Drug Administration [FDA] assumptions) for the treatment difference fell entirely within the equivalence margin of ±3 letters, as assessed in the full analysis set.</div></div><div><h3>Results</h3><div>Overall, 348 patients were randomized (CT-P42: 173; reference aflibercept: 175). Best-corrected visual acuity improved from baseline to week 8 in both groups, with a least squares mean (standard error) improvement of 9.43 (0.798) and 8.85 (0.775) letters in the CT-P42 and reference aflibercept groups, respectively. The estimated between-group treatment difference was 0.58 letters, with the CIs within the predefined equivalence margin of ±3 letters (95% CI, −0.73 to 1.88 [global]; 90% CI, −0.52 to 1.67 [FDA]). Through week 24, other efficacy results for the 2 groups, in terms of change in BCVA and retinal central subfield thickness, as well as ETDRS Diabetic Retinopathy Severity Scale score, supported therapeutic similarity. Pharmacokinetics, usability, safety (including the proportions of patients experiencing ≥1 treatment-emergent adverse event [CT-P42: 50.3%; reference aflibercept: 53.7%]), and immunogenicity were also comparable between groups.</div></div><div><h3>Conclusions</h3><div>This study in patients with DME demonstrated equivalence between CT-P42 and reference aflibercept (2 mg/0.05 ml) in terms of efficacy, with similar pharmacokinetic, usability, safety, and immunogenicity profiles.</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":"8 12","pages":"Pages 1163-1173"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141469808","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}

{"title":"A 3-Dimensional View of Prepapillary Vascular Loop","authors":"Savithiri Palanivel DOMS, DNB,&nbsp;Prabu Baskaran MS, DNB,&nbsp;Anand Rajendran DNB, FRCS","doi":"10.1016/j.oret.2024.05.005","DOIUrl":"10.1016/j.oret.2024.05.005","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"8 12","pages":"Page e49"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141284368","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}

{"title":"Impact of a Recall of Intravitreal Bevacizumab: a Health Analytics in Ophthalmology Registry Review","authors":"Hasenin Al-khersan MD ,&nbsp;Elioenai Garcia BS ,&nbsp;Kenneth C. Fan MD, MBA ,&nbsp;Patrick C. Staropoli MD ,&nbsp;Edward H. Wood MD ,&nbsp;Philip Storey MD ,&nbsp;Murtaza K. Adam MD ,&nbsp;David W. Parke III MD ,&nbsp;Lawrence S. Halperin MD ,&nbsp;Kevin Quinn BS ,&nbsp;Charles C. Wykoff MD, PhD","doi":"10.1016/j.oret.2024.08.021","DOIUrl":"10.1016/j.oret.2024.08.021","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"8 12","pages":"Pages 1211-1213"},"PeriodicalIF":4.4,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142133334","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}