JAMA ophthalmologyPub Date : 2025-04-10DOI: 10.1001/jamaophthalmol.2025.0588
Raymond T Kraker
{"title":"Telehealth for Children With Congenital Ectopia Lentis?","authors":"Raymond T Kraker","doi":"10.1001/jamaophthalmol.2025.0588","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2025.0588","url":null,"abstract":"","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"74 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819241","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}
JAMA ophthalmologyPub Date : 2025-04-10DOI: 10.1001/jamaophthalmol.2025.0526
Yiyuan Ma, Xinyu Zhang, Ling Jin, Siyuan Liu, Xiaolin Liang, Qian Ye, Xinxin Liu, Nathan Congdon, Danying Zheng, Guangming Jin
{"title":"Social Media Interventions and Postoperative Follow-Up in Congenital Ectopia Lentis","authors":"Yiyuan Ma, Xinyu Zhang, Ling Jin, Siyuan Liu, Xiaolin Liang, Qian Ye, Xinxin Liu, Nathan Congdon, Danying Zheng, Guangming Jin","doi":"10.1001/jamaophthalmol.2025.0526","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2025.0526","url":null,"abstract":"ImportanceCongenital ectopia lentis (CEL), often associated with systemic diseases such as Marfan syndrome, requires rigorous postoperative follow-up to reduce the risk of severe complications. However, follow-up rates are frequently suboptimal, indicating an urgent need for effective interventions to improve adherence.ObjectiveTo assess the effect of WeChat (Tencent Holdings Ltd), a social media smartphone communication application, in delivering phone reminders and health education to improve postoperative follow-up adherence among families of children with CEL.Design, Setting, and ParticipantsThis randomized clinical trial was conducted from December 2022 to October 2024. The study was conducted at the Zhongshan Ophthalmic Center, a tertiary ophthalmic hospital in Guangzhou, China. Families with children scheduled for lens surgery due to CEL were enrolled and randomized into the social media intervention group and the standard-care group.InterventionsParents in the social media intervention group received phone reminders and health education via the smartphone application before scheduled appointments at 1 week, 1 month, and 3 months after surgery.Main Outcomes and MeasuresThe primary outcome was follow-up attendance at 3 months after surgery.ResultsA total of 110 children were included in this study, 55 in the social media group (mean [SD] age, 6.9 [2.8] years; 32 male [58.2%]) and 55 in the standard-care group (mean [SD] age, 7.3 [3.4] years; 32 male [58.2%]). The intervention group exhibited higher attendance rates than the standard-care group across all 3 postoperative follow-ups (3 months: 83.6% [46 of 55] vs 41.8% [23 of 55]; 1 month: 81.8% [45 of 55] vs 58.2% [32 of 55]; 1 week: 92.7% [51 of 55] vs 87.3% [48 of 55]). Follow-up adherence at 3 months was significantly higher in the intervention group compared with the standard-care group (relative risk [RR], 2.05; 95% CI, 1.53-2.75; <jats:italic>P</jats:italic> &amp;lt; .001). In addition, the intervention group showed greater improvements in parental CEL knowledge accuracy (10.6%, 95% CI, 7.8%-13.5%) and higher rates of amblyopia treatments (RR, 2.40; 95% CI, 1.26-4.56).Conclusions and RelevanceResults of this randomized clinical trial reveal that social media smartphone application–based interventions significantly improved follow-up adherence and increased parental knowledge among families of children with CEL. These findings suggest that integrating mobile health technologies into standard care can enhance the management of progressive pediatric conditions with systemic risks, ultimately improving clinical outcomes.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT05628129\">NCT05628129</jats:ext-link>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"58 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819317","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}
JAMA ophthalmologyPub Date : 2025-04-10DOI: 10.1001/jamaophthalmol.2024.6371
M. Ali Khan, Lauren Hill, Ivaylo Stoilov, Julia A. Haller
{"title":"Race and Vision Outcomes in Ranibizumab-Treated Participants With Diabetic Macular Edema","authors":"M. Ali Khan, Lauren Hill, Ivaylo Stoilov, Julia A. Haller","doi":"10.1001/jamaophthalmol.2024.6371","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2024.6371","url":null,"abstract":"ImportanceVision outcomes in response to anti–vascular endothelial growth factor therapy for diabetic macular edema (DME) may differ between races. This meta-analysis investigated whether vision outcomes differed among racial subgroups treated with ranibizumab for DME in a clinical trial setting.ObjectiveTo assess the impact of race on vision outcomes in participants with DME treated with ranibizumab.Data SourcesFive randomized clinical trials were preselected for analysis, including the RIDE and RISE trials (Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus); Protocol I (Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination With Laser Photocoagulation for Diabetic Macular Edema), Protocol S (Prompt Panretinal Photocoagulation Versus Intravitreal Ranibizumab With Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy), and Protocol T (A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema).Study SelectionTargeted meta-analysis of data from 5 trials.Data Extraction and SynthesisTotal enrollment numbers allowed for comparison of Black and White participants with DME who were treated with ranibizumab (0.3 mg or 0.5 mg) and had best-corrected visual acuity (BCVA) data at baseline and month 24. Lower total enrollment of participants of other races precluded statistical analysis. All ranibizumab-treated arms were pooled. Differences in vision outcomes between Black and White participants were evaluated, adjusting for baseline vision. Propensity score–matched models for participants in RIDE/RISE were used to control for differences in baseline and on-study characteristics.Main Outcomes and MeasuresMean BCVA over time and mean change from baseline at month 24 by race (Black and White).ResultsAmong the 1109 participants, the mean age was 60.0 years (95% CI, 59.4-60.7); 621 participants were male and 488 were female; 181 participants were Black and 928 were White. BCVA was better at baseline in Black vs White participants (mean Early Treatment Diabetic Retinopathy Study [ETDRS] letter score, 66.7 [95% CI, 65.0-68.4] vs 62.0 [95% CI, 61.1-62.8], respectively) but similar at month 24 (mean ETDRS letter score, 72.8 [95% CI, 70.2-75.4] vs 72.2 [95% CI, 71.2-73.1]). Mean BCVA change from baseline at month 24 was lower in Black vs White participants (6.1 ETDRS letters [95% CI, 3.6-8.6] vs 10.2 ETDRS letters [95% CI, 9.3-11.1]) and after adjusting for differences in baseline BCVA (7.7 ETDRS letters [95% CI, 5.8-9.7] vs 9.9 ETDRS letters [95% CI, 9.0-10.7]). When groups were propensity score–matched in RIDE/RISE, mean BCVA change from baseline appeared similar between Black vs White participants (10.6 ETDRS letters [95% CI, 7.1-14.1] vs 10.1 ETDRS letters [95% CI, 7.3-12.9]; <jats:italic>P</jats:italic> = .83).Conclusions and RelevanceThis meta-analysis evaluating ranibizumab for DME found","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":"31 1","pages":""},"PeriodicalIF":8.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143819319","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}
JAMA ophthalmologyPub Date : 2025-04-01DOI: 10.1001/jamaophthalmol.2024.6492
Evgenia Konstantakopoulou, Gus Gazzard, David Garway-Heath, Mariam Adeleke, Gareth Ambler, Victoria Vickerstaff, Catey Bunce, Neil Nathwani, Keith Barton
{"title":"Selective Laser Trabeculoplasty After Medical Treatment for Glaucoma or Ocular Hypertension.","authors":"Evgenia Konstantakopoulou, Gus Gazzard, David Garway-Heath, Mariam Adeleke, Gareth Ambler, Victoria Vickerstaff, Catey Bunce, Neil Nathwani, Keith Barton","doi":"10.1001/jamaophthalmol.2024.6492","DOIUrl":"10.1001/jamaophthalmol.2024.6492","url":null,"abstract":"<p><strong>Importance: </strong>Primary selective laser trabeculoplasty (SLT) is a safe primary treatment for open-angle glaucoma (OAG) and ocular hypertension (OHT). However, there is limited evidence on its use as a secondary treatment, ie, after prior use of ocular hypotensive eye drops.</p><p><strong>Objective: </strong>To evaluate outcomes following SLT after using hypotensive eye drops for at least 3 years.</p><p><strong>Design, setting, and participants: </strong>This is a post hoc exploratory analysis of data from a multicenter randomized clinical trial conducted within the UK National Health Service. Participants were patients with OAG or OHT who participated in the LiGHT trial. Data were analyzed from February 2021 to December 2024.</p><p><strong>Intervention: </strong>Participants were initially randomized to either primary SLT or primary hypotensive eye drops and remained on the allocated treatment pathway for 3 years. Participants using eye drops were then allowed to have secondary SLT as a treatment switch (to reduce their medication load) or as a treatment escalation (if more intense treatment was needed). Participants were treated and monitored according to a predefined protocol.</p><p><strong>Main outcomes and measures: </strong>The outcomes of interest were rates of incisional glaucoma surgery, medication use, and intraocular pressure.</p><p><strong>Results: </strong>In total, 633 participants entered the extension of the LiGHT trial, and 524 participants (82.8%) completed the extension (72 months). Of 320 participants receiving primary hypotensive eye drops, 112 (35.0%) received SLT: 70 participants switched to SLT, 29 participants had SLT as a treatment escalation, and 13 participants had SLT as a treatment escalation in 1 eye and as a treatment switch in the other eye. Switching to SLT was associated with a reduction in the number of medications (mean [SD], 1.38 [0.62] to 0.59 [0.92] active ingredients; mean difference, 0.79 [95% CI 0.66 to 0.93] active ingredients; P < .001). At 72 months, 69 eyes that switched to SLT (60.5%) needed no medical or surgical treatment, and 62 eyes receiving 1 drug before switching (83.8%) needed no medical treatment. Escalating to SLT was associated with a mean intraocular pressure reduction of 4.6 mm Hg (21.8%), and 30 eyes (62.5%) reached target intraocular pressure at 72 months without the need for surgery; 9 eyes (18.7%) needed a trabeculectomy.</p><p><strong>Conclusions and relevance: </strong>This secondary analysis of a randomized clinical trial found that secondary SLT was associated with a reduction in the medication load for stable, medically treated eyes. For medically uncontrolled eyes, there is evidence that SLT could provide additional intraocular pressure control, but the need for trabeculectomy was not eliminated.</p><p><strong>Trial registration: </strong>isrctn.org Identifier: ISRCTN32038223.</p>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"295-302"},"PeriodicalIF":7.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11843460/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458117","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}
JAMA ophthalmologyPub Date : 2025-04-01DOI: 10.1001/jamaophthalmol.2024.6114
Elisabeth J Cohen, Andrea B Troxel, Mengling Liu, Judith S Hochman, Keith H Baratz, Shahzad I Mian, Mazen Y Choulakian, David B Warner, Ying Lu, Alberta Twi-Yeboah, Ting-Fang Lee, Jiyu Kim, Carlos Lopez-Jimenez, Sarah C Laury, Bennie H Jeng
{"title":"Low-Dose Valacyclovir in Herpes Zoster Ophthalmicus: The Zoster Eye Disease Randomized Clinical Trial.","authors":"Elisabeth J Cohen, Andrea B Troxel, Mengling Liu, Judith S Hochman, Keith H Baratz, Shahzad I Mian, Mazen Y Choulakian, David B Warner, Ying Lu, Alberta Twi-Yeboah, Ting-Fang Lee, Jiyu Kim, Carlos Lopez-Jimenez, Sarah C Laury, Bennie H Jeng","doi":"10.1001/jamaophthalmol.2024.6114","DOIUrl":"10.1001/jamaophthalmol.2024.6114","url":null,"abstract":"<p><strong>Importance: </strong>High-quality evidence regarding suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) is necessary to guide care.</p><p><strong>Objective: </strong>To determine whether suppressive valacyclovir compared with placebo delays the occurrence of new or worsening stromal keratitis (SK), endothelial keratitis (EK), iritis, or dendriform epithelial keratitis (DEK) during 12 months of treatment and if treatment benefit persisted at 18 months (secondary end point).</p><p><strong>Design, setting, and participants: </strong>The Zoster Eye Disease Study (ZEDS) was a randomized clinical trial conducted in 95 sites from November 2017 to June 2024. Immunocompetent, nonpregnant adults with a history of an HZO rash, documented active keratitis or iritis within 1 year, and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater were eligible. After determined to be eligible, participants were randomized in 4 strata: age at onset (<60 years vs ≥60 years) and disease duration (<6 months vs ≥6 months).</p><p><strong>Interventions: </strong>A total of 12 months of double-masked daily valacyclovir, 1000 mg, or placebo.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was time to first occurrence within 12 months of new or worsening SK, EK, iritis, or DEK.</p><p><strong>Results: </strong>A total of 527 participants (median [IQR] age, 60 [50-68] years; 266 female [50.5%]; 266 in the valacyclovir group; 261 in the placebo group) were randomized in 4 strata; 481 completed 12 months, and 460 completed 18 months. Data were analyzed by intention to treat. At 12 months, primary end points occurred in 86 participants (33%) assigned to placebo and 74 (28%) assigned to valacyclovir, and at 18 months in 104 participants (40%) assigned to placebo and 86 (32%) assigned to valacyclovir. The hazard ratio (HR) of the primary end point at 12 months was 0.77 for participants taking valacyclovir vs placebo (HR, 0.77; adjusted 95% CI, 0.56-1.05; P = .09) and 0.73 at the secondary end point at 18 months (HR, 0.73; adjusted 95% CI, 0.55-0.97; P = .03). There was a reduction of multiple other secondary end points at 12 months (HR, 0.70; 95% CI, 0.52-0.95; P = .02) and 18 months (HR, 0.72; 95% CI, 0.55-0.95; P = .02).</p><p><strong>Conclusions and relevance: </strong>Although the primary outcome did not show a benefit of suppressive valacyclovir treatment, secondary study outcomes showed treatment superiority at the 18-month end point and reduced number of multiple episodes of keratitis or iritis at both 12 and 18 months. These results support consideration of 1 year of suppressive valacyclovir treatment for HZO.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03134196.</p>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"269-276"},"PeriodicalIF":7.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567022","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}
JAMA ophthalmologyPub Date : 2025-04-01DOI: 10.1001/jamaophthalmol.2025.0001
Dante J Pieramici, Carl C Awh, Margaret Chang, Andres Emanuelli, Nancy M Holekamp, Allen Y Hu, Ivan J Suñer, Charles C Wykoff, Christopher Brittain, Dena Howard, Carlos Quezada-Ruiz, Anjana Santhanakrishnan, Paul Latkany
{"title":"Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial.","authors":"Dante J Pieramici, Carl C Awh, Margaret Chang, Andres Emanuelli, Nancy M Holekamp, Allen Y Hu, Ivan J Suñer, Charles C Wykoff, Christopher Brittain, Dena Howard, Carlos Quezada-Ruiz, Anjana Santhanakrishnan, Paul Latkany","doi":"10.1001/jamaophthalmol.2025.0001","DOIUrl":"10.1001/jamaophthalmol.2025.0001","url":null,"abstract":"<p><strong>Importance: </strong>Frequent prophylactic intravitreal anti-vascular endothelial growth factor injections can reduce risk of progression to vision-threatening complications in nonproliferative diabetic retinopathy (NPDR). A refillable drug delivery system for continuous intraocular ranibizumab release could offer less frequent treatment regimens.</p><p><strong>Objective: </strong>To evaluate the Port Delivery System (PDS) with ranibizumab, 100 mg/mL, with refill-exchange procedures every 36 weeks (PDS Q36W), vs no PDS (control) in moderately severe to severe NPDR without center-involved diabetic macular edema (CI-DME), monitoring both groups every 4 weeks.</p><p><strong>Design, setting, and participants: </strong>This was a randomized clinical trial at 50 US investigational sites. Participants aged 18 years or older with moderately severe or severe NPDR (Diabetic Retinopathy Severity Scale [DRSS] level 47 or 53) secondary to type 1 or 2 diabetes were eligible. Data analysis was performed from August 10, 2020, to October 3, 2022.</p><p><strong>Intervention: </strong>Participants were randomized (unmasked) 5:3 to PDS Q36W vs control. Both groups could receive intravitreal ranibizumab injections if CI-DME, proliferative diabetic retinopathy (PDR), or anterior segment neovascularization (ASNV) developed.</p><p><strong>Main outcomes and measures: </strong>Proportion of participants with an improvement of at least 2 levels in Early Treatment Diabetic Retinopathy Study DRSS from baseline at week 52.</p><p><strong>Results: </strong>A total of 174 participants (mean [SD] age, 53.9 [11.7] years; 74 [42.5%] female) were randomized to PDS Q36W (n = 106) or control (n = 68). At week 52, 80.1% of those receiving PDS Q36W vs 9.0% of control participants had at least a 2-step DRSS improvement from baseline (difference, 71.1% [95% CI, 61.0% to 81.2%]; P < .001). Secondary outcomes included rate of development of CI-DME, PDR, or ASNV through week 52 (PDS Q36W, 7.1%; control, 47.0%; hazard ratio, 0.12 [95% CI, 0.05 to 0.28]; P < .001) and best-corrected visual acuity (BCVA) change from baseline to week 52 (+1.4 letters [95% CI, -0.5 to 3.3 letters] for those receiving PDS Q36W vs -2.6 letters [95% CI, -5.0 to -0.1 letters] for control participants; difference, 4.0 letters [95% CI, 0.9 to 7.1 letters]; P = .01). The PDS Q36W group had a transient BCVA decrease of 7.4 letters (95% CI, -10.3 to -4.5 letters) at 4 weeks after implantation, resolving 8 weeks later. Ocular adverse events of special interest occurred in 17 of 105 participants (16.2%) receiving PDS Q36W (cataract, 7 participants [6.7%]; vitreous hemorrhage, 6 participants [5.7%]; conjunctival bleb, conjunctival retraction, and hyphema, each 2 participants [1.9%]; conjunctival erosion and retinal detachment, each 1 participant [1.0%]), with no endophthalmitis reported through week 52.</p><p><strong>Conclusions and relevance: </strong>At 1 year, PDS Q36W resulted in substantially more participant","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"317-325"},"PeriodicalIF":7.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886866/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567025","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}
JAMA ophthalmologyPub Date : 2025-04-01DOI: 10.1001/jamaophthalmol.2025.0006
Arshad M Khanani, Peter A Campochiaro, Jordan M Graff, Dennis M Marcus, Daniel Miller, Robert A Mittra, Carl Regillo, Veeral S Sheth, Ashwini Bobbala, Shamika Gune, Stephanie Lin, Carlos Quezada-Ruiz, Varun Malhotra
{"title":"Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial.","authors":"Arshad M Khanani, Peter A Campochiaro, Jordan M Graff, Dennis M Marcus, Daniel Miller, Robert A Mittra, Carl Regillo, Veeral S Sheth, Ashwini Bobbala, Shamika Gune, Stephanie Lin, Carlos Quezada-Ruiz, Varun Malhotra","doi":"10.1001/jamaophthalmol.2025.0006","DOIUrl":"10.1001/jamaophthalmol.2025.0006","url":null,"abstract":"<p><strong>Importance: </strong>Frequent visits and intravitreal anti-vascular endothelial growth factor (VEGF) injections are often required to manage diabetic macular edema (DME), burdening patients and their health care networks. The Port Delivery System (PDS) with ranibizumab is the first continuous anti-VEGF therapy that has the potential to reduce visit and treatment burden without sacrificing vision outcomes for patients with DME.</p><p><strong>Objective: </strong>To evaluate the efficacy and safety through 64 weeks of ranibizumab, 100 mg/mL, via PDS with refill exchanges every 24 weeks (PDS Q24W) in patients with DME vs intravitreal injections of ranibizumab, 0.5 mg, every 4 weeks (monthly ranibizumab).</p><p><strong>Design, setting, and participants: </strong>This randomized clinical trial was a phase 3, multicenter, noninferiority trial conducted across 87 sites in the US. Treatment-naïve patients at least 18 years old with center-involved DME were eligible for study participation. Enrollment was from September 30, 2019, to June 25, 2021; data were analyzed from September 30, 2019, to September 19, 2022.</p><p><strong>Intervention: </strong>Participants were randomized 3:2 to receive 4 monthly doses of ranibizumab, 0.5 mg, followed by ranibizumab, 100 mg/mL, via PDS Q24W or monthly ranibizumab.</p><p><strong>Main outcome and measure: </strong>The primary end point was change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 60 and 64.</p><p><strong>Results: </strong>A total of 634 participants were randomized (PDS Q24W group, n = 381; monthly ranibizumab, n = 253). The mean (SD) age at baseline was 60.7 (9.6) years; 363 (57.3%) participants were male and 271 (42.7%) female. Adjusted mean BCVA change from baseline averaged over weeks 60 and 64 was an increase of 9.6 letters for PDS Q24W and 9.4 letters for monthly ranibizumab (difference, 0.2; 95% CI, -1.2 to 1.6), meeting the primary end point of PDS noninferiority (margin, -4.5 letters). PDS Q24W participants had a mean (SD) decrease of 6.7 (12.0) letters 4 weeks after PDS insertion; mean BCVA was similar to monthly ranibizumab 16 weeks after implantation. Adverse events of special interest were more common in the PDS Q24W group (88 participants; 27.5%) than the monthly ranibizumab group (28 participants; 8.9%). No cases of endophthalmitis or retinal detachment were reported with PDS Q24W.</p><p><strong>Conclusions and relevance: </strong>This trial found that changes in BCVA from baseline averaged over weeks 60/64 in the PDS Q24W group were comparable to the monthly ranibizumab group. While AESIs were more common with PDS Q24W, there were no instances of endophthalmitis or retinal detachment. Continuous ranibizumab, 100 mg/mL, via PDS was approved in the US for patients with DME in February 2025 and provides effective, durable, and generally well-tolerated treatment for DME with retreatment every 6 months through at least 64 weeks.</p><p><strong>Trial registrati","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"326-335"},"PeriodicalIF":7.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11886869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566998","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}
JAMA ophthalmologyPub Date : 2025-04-01DOI: 10.1001/jamaophthalmol.2025.0005
Joseph F Rizzo, Jimena Tatiana Hathaway
{"title":"Semaglutide and Risk of NAION-Additional Insights.","authors":"Joseph F Rizzo, Jimena Tatiana Hathaway","doi":"10.1001/jamaophthalmol.2025.0005","DOIUrl":"10.1001/jamaophthalmol.2025.0005","url":null,"abstract":"","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":"315-316"},"PeriodicalIF":7.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143458119","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}