Pub Date : 2025-03-06DOI: 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
Importance: High-quality evidence regarding suppressive valacyclovir treatment in herpes zoster ophthalmicus (HZO) is necessary to guide care.
Objective: 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).
Design, setting, and participants: 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).
Interventions: A total of 12 months of double-masked daily valacyclovir, 1000 mg, or placebo.
Main outcomes and measures: The primary outcome was time to first occurrence within 12 months of new or worsening SK, EK, iritis, or DEK.
Results: 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).
Conclusions and relevance: 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.
{"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":"https://doi.org/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":""},"PeriodicalIF":7.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-06DOI: 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
<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
{"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":"https://doi.org/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":""},"PeriodicalIF":7.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-06DOI: 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
<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
{"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":"https://doi.org/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":""},"PeriodicalIF":7.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","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":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-06DOI: 10.1001/jamaophthalmol.2025.0111
Bryanna Lee, Jennifer Bu, Nathan Scott
{"title":"Conjunctival Nodule in a Female With Ulcerative Colitis.","authors":"Bryanna Lee, Jennifer Bu, Nathan Scott","doi":"10.1001/jamaophthalmol.2025.0111","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2025.0111","url":null,"abstract":"","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":""},"PeriodicalIF":7.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143566879","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-03-06DOI: 10.1001/jamaophthalmol.2024.6113
David B Warner, Bennie H Jeng, Jiyu Kim, Mengling Liu, Andrea B Troxel, Judith S Hochman, Keith H Baratz, Shahzad I Mian, Mazen Y Choulakian, Jay J Meyer, Ying Lu, Alberta Twi-Yeboah, Ting-Fang Lee, Carlos Lopez-Jimenez, Sarah C Laury, Elisabeth J Cohen
<p><strong>Importance: </strong>Evidence regarding suppressive valacyclovir treatment on postherpetic neuralgia is necessary to guide care.</p><p><strong>Objective: </strong>To test the hypothesis that suppressive treatment with 1000 mg/d of oral valacyclovir for 12 months reduces the prevalence, severity, and duration of postherpetic neuralgia compared with placebo at 12 and 18 months in participants with herpes zoster ophthalmicus (HZO).</p><p><strong>Design, setting, and participants: </strong>Multicenter, placebo-controlled randomized clinical trial including 527 immunocompetent, nonpregnant adults with history of HZO rash, documented keratitis, or iritis within 1 year and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater. The study was conducted at 95 participating sites (in Canada, New Zealand, and the US) from November 2017 to June 2024 and participant visits occurred every 3 months.</p><p><strong>Intervention: </strong>Treatment with 1000 mg/d of valacyclovir or placebo for 12 months.</p><p><strong>Main outcomes and measures: </strong>Prevalence of postherpetic neuralgia, severity as determined by pain score (a score of ≥3 on a scale of 1-10), pain duration (≥3 months after HZO onset), and total daily dose of pain medication.</p><p><strong>Results: </strong>Of the 527 participants (490 completed 12 months of treatment and 460 completed 18 months), 73 (14%) had postherpetic neuralgia and were analyzed by age at HZO onset (<60 years or ≥60 years) and disease duration (recent [<6 months] or chronic [≥6 months]). Of the 73 participants with postherpetic neuralgia (34 in the valacyclovir group and 39 in the placebo group), the mean age was 62.4 years (SD, 13.6 years), 59% were female, 5% were Black or African American, and 10% were Hispanic. The prevalence of postherpetic neuralgia at 12 months was not reduced by valacyclovir (12/32 [38%]) compared with placebo (14/35 [40%]) (between-group difference, 2.5% [95% CI, -20.8% to 25.8%]; P>.99). The participants who were younger than 60 years at HZO onset and had a chronic disease duration had lower pain scores in the valacyclovir group (mean score, 0.3 [SD, 0.9]) vs the placebo group (mean score, 0.8 [SD, 1.9]) at 12 months (P = .045) and at 18 months (mean score, 0.2 [SD, 0.9] vs 1.0 [SD, 2.3], respectively; P = .02). There was a decrease in pain duration in the valacyclovir group at 18 months (mean, 13.6 [SD, 11.4] months) vs the placebo group (mean, 18.7 [SD, 29.5] months) (linear mixed-effects model between-group difference, -3.39 months [95% CI, -6.73 to -0.04 months]; P = .046). The total daily dose of neuropathic pain medication was lower in the valacyclovir group (mean, 271.4 [SD, 593.8] mg/d) vs the placebo group (mean, 363.4 [SD, 592.2] mg/d) at 12 months (linear mixed-effects model P = .006) and at 18 months (mean, 209.0 [SD, 412.8] mg/d vs 286.2 [SD, 577.9] mg/d, respectively; linear mixed-effects model P = .01).</p><p><strong>Conclusions and relevance: </strong>O
{"title":"Low-Dose Valacyclovir for Postherpetic Neuralgia in the Zoster Eye Disease Study: A Randomized Clinical Trial.","authors":"David B Warner, Bennie H Jeng, Jiyu Kim, Mengling Liu, Andrea B Troxel, Judith S Hochman, Keith H Baratz, Shahzad I Mian, Mazen Y Choulakian, Jay J Meyer, Ying Lu, Alberta Twi-Yeboah, Ting-Fang Lee, Carlos Lopez-Jimenez, Sarah C Laury, Elisabeth J Cohen","doi":"10.1001/jamaophthalmol.2024.6113","DOIUrl":"https://doi.org/10.1001/jamaophthalmol.2024.6113","url":null,"abstract":"<p><strong>Importance: </strong>Evidence regarding suppressive valacyclovir treatment on postherpetic neuralgia is necessary to guide care.</p><p><strong>Objective: </strong>To test the hypothesis that suppressive treatment with 1000 mg/d of oral valacyclovir for 12 months reduces the prevalence, severity, and duration of postherpetic neuralgia compared with placebo at 12 and 18 months in participants with herpes zoster ophthalmicus (HZO).</p><p><strong>Design, setting, and participants: </strong>Multicenter, placebo-controlled randomized clinical trial including 527 immunocompetent, nonpregnant adults with history of HZO rash, documented keratitis, or iritis within 1 year and an estimated glomerular filtration rate of 45 mL/min/1.73 m2 or greater. The study was conducted at 95 participating sites (in Canada, New Zealand, and the US) from November 2017 to June 2024 and participant visits occurred every 3 months.</p><p><strong>Intervention: </strong>Treatment with 1000 mg/d of valacyclovir or placebo for 12 months.</p><p><strong>Main outcomes and measures: </strong>Prevalence of postherpetic neuralgia, severity as determined by pain score (a score of ≥3 on a scale of 1-10), pain duration (≥3 months after HZO onset), and total daily dose of pain medication.</p><p><strong>Results: </strong>Of the 527 participants (490 completed 12 months of treatment and 460 completed 18 months), 73 (14%) had postherpetic neuralgia and were analyzed by age at HZO onset (<60 years or ≥60 years) and disease duration (recent [<6 months] or chronic [≥6 months]). Of the 73 participants with postherpetic neuralgia (34 in the valacyclovir group and 39 in the placebo group), the mean age was 62.4 years (SD, 13.6 years), 59% were female, 5% were Black or African American, and 10% were Hispanic. The prevalence of postherpetic neuralgia at 12 months was not reduced by valacyclovir (12/32 [38%]) compared with placebo (14/35 [40%]) (between-group difference, 2.5% [95% CI, -20.8% to 25.8%]; P>.99). The participants who were younger than 60 years at HZO onset and had a chronic disease duration had lower pain scores in the valacyclovir group (mean score, 0.3 [SD, 0.9]) vs the placebo group (mean score, 0.8 [SD, 1.9]) at 12 months (P = .045) and at 18 months (mean score, 0.2 [SD, 0.9] vs 1.0 [SD, 2.3], respectively; P = .02). There was a decrease in pain duration in the valacyclovir group at 18 months (mean, 13.6 [SD, 11.4] months) vs the placebo group (mean, 18.7 [SD, 29.5] months) (linear mixed-effects model between-group difference, -3.39 months [95% CI, -6.73 to -0.04 months]; P = .046). The total daily dose of neuropathic pain medication was lower in the valacyclovir group (mean, 271.4 [SD, 593.8] mg/d) vs the placebo group (mean, 363.4 [SD, 592.2] mg/d) at 12 months (linear mixed-effects model P = .006) and at 18 months (mean, 209.0 [SD, 412.8] mg/d vs 286.2 [SD, 577.9] mg/d, respectively; linear mixed-effects model P = .01).</p><p><strong>Conclusions and relevance: </strong>O","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":""},"PeriodicalIF":7.8,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143567017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1001/jamaophthalmol.2024.6337
Hwa Young Ahn, Min Joung Lee, Kyong Yeun Jung, Hyo-Jeong Kim, Eun Hye Jung, Chae Won Chung, Kyungsik Kim, Jinsun Jang, Young Joo Park, Jeong Kyu Lee, Sun Wook Cho
Importance: Graves ophthalmopathy significantly diminishes patients' quality of life due to its immune-mediated inflammatory effects on the orbital tissues. Selenium, with its antioxidative properties, has shown potential for improving Graves ophthalmopathy progression and quality of life (QOL); however, its effectiveness in selenium-sufficient regions is not well established.
Objective: To determine whether selenium supplementation improves QOL in patients with mild to moderate Graves ophthalmopathy in selenium-sufficient regions.
Design, setting, and participants: The Efficacy of Selenium Supplementation for Mild-to-Moderate Graves' Ophthalmopathy in a Selenium-Sufficient Area (SeGOSS) trial was a randomized, open-label multicenter study. Eighty-four patients with mild to moderate Graves' ophthalmopathy were enrolled; 70 completed the study. Participants were selected based on Graves ophthalmopathy diagnosis and sufficient selenium levels. Data were analyzed from October 2023 to March 2024.
Interventions: Participants received selenium supplementation combined with vitamin B complex for 6 months.
Main outcomes and measures: The primary outcome was improvements in Graves ophthalmopathy QOL (GO-QOL) scores at 6 months. Secondary outcomes included changes in GO-QOL scores at 3 months, the proportion of patients showing improvement based on GO-QOL scores, clinical activity score, and ophthalmic examinations at 3 months and 6 months, and changes in thyroid autoantibodies at 3 months and 6 months.
Results: There was no improvement in changes in the total GO-QOL scores between the selenium group (31 female patients [83.8%] and 7 male patients [16.2%]; mean [SD] age, 40.8 [11.7] years) and control group (24 female patients [72.7%] and 9 male patients [27.3%]; mean [SD] age, 42.9 [14.2] years) for the primary outcome at 6 months (mean [SD], 12.2 [22.5] vs mean [SD], 11.2 [20.2]; difference, 0.9; 95% CI, -9.3 to 11.3; P = .85). However, at 3 months, a higher proportion of patients in the selenium group showed improved GO-QOL scores compared with the control group (78.4 vs 48.5%; difference, 0.30; 95% CI, 0.08-0.51; P = .01). The selenium group also had higher rates of improvement in proptosis reduction (49.5 vs 15.1%; difference, 0.31; 95% CI, 0.11-0.51; P = .01) at 3 months, though these effects were not sustained at 6 months.
Conclusions and relevance: These results suggest that selenium supplementation did not improve QOL or clinical parameters in patients with mild to moderate GO in selenium-sufficient regions at 6 months. Some potential QOL benefits noted at 3 months supports consideration of further investigation of selenium for patients seeking treatment for Graves ophthalmopathy .
Trial registration: Clinical Research Information Service Identifier KCT0004040.
{"title":"Selenium vs Control for Graves Ophthalmopathy in a Selenium-Sufficient Area: A Randomized Clinical Trial.","authors":"Hwa Young Ahn, Min Joung Lee, Kyong Yeun Jung, Hyo-Jeong Kim, Eun Hye Jung, Chae Won Chung, Kyungsik Kim, Jinsun Jang, Young Joo Park, Jeong Kyu Lee, Sun Wook Cho","doi":"10.1001/jamaophthalmol.2024.6337","DOIUrl":"10.1001/jamaophthalmol.2024.6337","url":null,"abstract":"<p><strong>Importance: </strong>Graves ophthalmopathy significantly diminishes patients' quality of life due to its immune-mediated inflammatory effects on the orbital tissues. Selenium, with its antioxidative properties, has shown potential for improving Graves ophthalmopathy progression and quality of life (QOL); however, its effectiveness in selenium-sufficient regions is not well established.</p><p><strong>Objective: </strong>To determine whether selenium supplementation improves QOL in patients with mild to moderate Graves ophthalmopathy in selenium-sufficient regions.</p><p><strong>Design, setting, and participants: </strong>The Efficacy of Selenium Supplementation for Mild-to-Moderate Graves' Ophthalmopathy in a Selenium-Sufficient Area (SeGOSS) trial was a randomized, open-label multicenter study. Eighty-four patients with mild to moderate Graves' ophthalmopathy were enrolled; 70 completed the study. Participants were selected based on Graves ophthalmopathy diagnosis and sufficient selenium levels. Data were analyzed from October 2023 to March 2024.</p><p><strong>Interventions: </strong>Participants received selenium supplementation combined with vitamin B complex for 6 months.</p><p><strong>Main outcomes and measures: </strong>The primary outcome was improvements in Graves ophthalmopathy QOL (GO-QOL) scores at 6 months. Secondary outcomes included changes in GO-QOL scores at 3 months, the proportion of patients showing improvement based on GO-QOL scores, clinical activity score, and ophthalmic examinations at 3 months and 6 months, and changes in thyroid autoantibodies at 3 months and 6 months.</p><p><strong>Results: </strong>There was no improvement in changes in the total GO-QOL scores between the selenium group (31 female patients [83.8%] and 7 male patients [16.2%]; mean [SD] age, 40.8 [11.7] years) and control group (24 female patients [72.7%] and 9 male patients [27.3%]; mean [SD] age, 42.9 [14.2] years) for the primary outcome at 6 months (mean [SD], 12.2 [22.5] vs mean [SD], 11.2 [20.2]; difference, 0.9; 95% CI, -9.3 to 11.3; P = .85). However, at 3 months, a higher proportion of patients in the selenium group showed improved GO-QOL scores compared with the control group (78.4 vs 48.5%; difference, 0.30; 95% CI, 0.08-0.51; P = .01). The selenium group also had higher rates of improvement in proptosis reduction (49.5 vs 15.1%; difference, 0.31; 95% CI, 0.11-0.51; P = .01) at 3 months, though these effects were not sustained at 6 months.</p><p><strong>Conclusions and relevance: </strong>These results suggest that selenium supplementation did not improve QOL or clinical parameters in patients with mild to moderate GO in selenium-sufficient regions at 6 months. Some potential QOL benefits noted at 3 months supports consideration of further investigation of selenium for patients seeking treatment for Graves ophthalmopathy .</p><p><strong>Trial registration: </strong>Clinical Research Information Service Identifier KCT0004040.</p>","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":""},"PeriodicalIF":7.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-27DOI: 10.1001/jamaophthalmol.2025.0002
Geronimo Bejarano, Hamid Torabzadeh, Durga Borkar, Christopher Whaley, Yashaswini Singh
{"title":"Private Equity Acquisitions and Industry Payments in Ophthalmology.","authors":"Geronimo Bejarano, Hamid Torabzadeh, Durga Borkar, Christopher Whaley, Yashaswini Singh","doi":"10.1001/jamaophthalmol.2025.0002","DOIUrl":"10.1001/jamaophthalmol.2025.0002","url":null,"abstract":"","PeriodicalId":14518,"journal":{"name":"JAMA ophthalmology","volume":" ","pages":""},"PeriodicalIF":7.8,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11869085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143515641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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