To determine the ultra-widefield fluorescein angiographic (UWFA) characteristics of patients with mild familial exudative vitreoretinopathy (FEVR) who had been confirmed to have pathogenic variants of the autosomal dominant (AD) genes of FEVR.
Design
Single center, observational case series.
Subjects and Controls
Thirty-seven patients with mild FEVR from 27 families who had pathogenic variants of the Norrin/β-catenin genes were studied. The controls consisted of 32 family members who had been confirmed not to carry the pathogenic variants or had heterozygous variants of the autosomal recessive inheritance gene.
Methods
Sixty-four UWFA images from the patients were compared with 60 UWFA images from the controls. The relative length of the temporal retina to the peripheral avascular retina was determined. The cut-off ratio of the relative lengths for a clinically significant avascular retina (csAR) associated with AD-FEVR was determined using the receiver operating characteristic (ROC) curves.
Main Outcome Measures
The presence or absence of 6 peripheral vascular changes (csAR, V-shaped vascular notch, brushy vascular ends, vascular stain, loop vessels or anastomosis, and capillary telangiectasia) were compared between the patients and the controls.
Results
The csAR was set at > 12% of the length from the ora serrata to the optic disc. The patients with AD-FEVR had more frequent retinal changes than the controls for the V-shaped vascular notch (69% vs. 2%; P < 0.001), brushy vascular ends (78% vs. 3%; P < 0.001), csAR (83% vs. 22%; P < 0.001), and vascular stain (70% vs. 35%, P < 0.001). Loop vessels and/or anastomosis of peripheral vessels were found significantly less frequently in the patients than in the controls (39% vs. 73%; P < 0.001). No significant difference was found for capillary telangiectasia between the 2 groups. The combination of the V-shaped vascular notches, brushy vascular ends, and csAR had a sensitivity of 82.8% and specificity of 98.3%, with the highest ROC curve of 0.9.
Conclusions
The combination of V-shaped vascular notch, brushy vascular ends, and csAR can be used as a biomarker for patients with AD-FEVR who have pathogenic variants of the Norrin/β-catenin genes. These findings will allow more accurate segregation analysis in FEVR families and allow better genetic counseling.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Angiographic Characteristics in Mild Familial Exudative Vitreoretinopathy with Genetically Confirmed Autosomal Dominant Inheritance","authors":"Misato Okamoto MD , Itsuka Matsushita MD, PhD , Tatsuo Nagata MD, PhD , Yoshihisa Fujino MD, PhD , Hiroyuki Kondo MD, PhD","doi":"10.1016/j.oret.2024.08.013","DOIUrl":"10.1016/j.oret.2024.08.013","url":null,"abstract":"<div><h3>Purpose</h3><div>To determine the ultra-widefield fluorescein angiographic (UWFA) characteristics of patients with mild familial exudative vitreoretinopathy (FEVR) who had been confirmed to have pathogenic variants of the autosomal dominant (AD) genes of FEVR.</div></div><div><h3>Design</h3><div>Single center, observational case series.</div></div><div><h3>Subjects and Controls</h3><div>Thirty-seven patients with mild FEVR from 27 families who had pathogenic variants of the Norrin/β-catenin genes were studied. The controls consisted of 32 family members who had been confirmed not to carry the pathogenic variants or had heterozygous variants of the autosomal recessive inheritance gene.</div></div><div><h3>Methods</h3><div>Sixty-four UWFA images from the patients were compared with 60 UWFA images from the controls. The relative length of the temporal retina to the peripheral avascular retina was determined. The cut-off ratio of the relative lengths for a clinically significant avascular retina (csAR) associated with AD-FEVR was determined using the receiver operating characteristic (ROC) curves.</div></div><div><h3>Main Outcome Measures</h3><div>The presence or absence of 6 peripheral vascular changes (csAR, V-shaped vascular notch, brushy vascular ends, vascular stain, loop vessels or anastomosis, and capillary telangiectasia) were compared between the patients and the controls.</div></div><div><h3>Results</h3><div>The csAR was set at > 12% of the length from the ora serrata to the optic disc. The patients with AD-FEVR had more frequent retinal changes than the controls for the V-shaped vascular notch (69% vs. 2%; <em>P</em> < 0.001), brushy vascular ends (78% vs. 3%; <em>P</em> < 0.001), csAR (83% vs. 22%; <em>P</em> < 0.001), and vascular stain (70% vs. 35%, <em>P</em> < 0.001). Loop vessels and/or anastomosis of peripheral vessels were found significantly less frequently in the patients than in the controls (39% vs. 73%; <em>P</em> < 0.001). No significant difference was found for capillary telangiectasia between the 2 groups. The combination of the V-shaped vascular notches, brushy vascular ends, and csAR had a sensitivity of 82.8% and specificity of 98.3%, with the highest ROC curve of 0.9.</div></div><div><h3>Conclusions</h3><div>The combination of V-shaped vascular notch, brushy vascular ends, and csAR can be used as a biomarker for patients with AD-FEVR who have pathogenic variants of the Norrin/β-catenin genes. These findings will allow more accurate segregation analysis in FEVR families and allow better genetic counseling.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 187-193"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142093653","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.08.004
Marie-Michele Macaron BSc , Nader Al Sabbakh BSc , M Zaid Shami MD , Dennis Akrobetu MD , Natalie E. Bourdakos BSc , Fatma A.M. Abdulsalam MBBS , Hayato Nakanishi MBBS, MS , Christian A. Than MBBS, PhD , Sophie J. Bakri MD
<div><h3>Topic</h3><div>To evaluate the efficacy and safety of anti-VEGF and panretinal photocoagulation (PRP) for the treatment of proliferative diabetic retinopathy (PDR). The outcomes examined are changes in best-corrected visual acuity (BCVA), neovascularization (NV), central macular thickness (CMT), and adverse outcomes.</div></div><div><h3>Clinical relevance</h3><div>Diabetic retinopathy is the leading cause of blindness in working-aged adults globally. At present, no consensus has been reached on the optimal choice for the treatment of PDR.</div></div><div><h3>Methods</h3><div>Cochrane, Embase, PubMed, Scopus, Web of Science, and CiNAHL were searched for articles from their inception to June 2023 according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis. The review was registered prospectively with PROSPERO (CRD42023437778). Tool data analysis was performed using RevMan software version 5.4 (Review Manager [RevMan] [computer program], The Cochrane Collaboration, 2020). Randomized control trials (RCTs) of PDR patients treated with anti-VEGF, PRP, or a combination were included. Risk of bias was assessed using the Rob2 assessment tool (revised tool for risk of bias in randomized trials), and certainty of evidence was assessed with the Grading Recommendations Assessment, Development and Evaluation (GRADE) approach.</div></div><div><h3>Results</h3><div>Nineteen studies were included, with 1361 patients (n = 1788 eyes) treated for PDR with either anti-VEGF (n = 274), PRP (n = 482), or combination (n = 320). Our results show more favorable BCVA outcomes with anti-VEGF compared with PRP at 3 months (mean difference [MD] = 2.35 letters; 95% confidence interval [CI], 1.18–3.52; I<sup>2</sup> = 0%) and 12 months follow-up (MD = 3.39 letters; 95% CI, 0.63–6.14; I<sup>2</sup> = 26%). Combination treatment showed better BCVA outcomes compared with PRP at 12 months (MD = 4.06 letters; 95% CI, 0.26–7.86; I<sup>2</sup> = 0%). Combination showed lower CMT at 3 months (MD = −33.10 μm; 95% CI, −40.12 to −26.08; I<sup>2</sup> = 25%) and 6 months (MD = −34.28 μm; 95% CI, −55.59 to −12.97; I<sup>2</sup> = 85%) compared with PRP, but CMT results were similar at 12 months. Complete regression of total NV (NVT) was more likely with anti-VEGF compared with PRP (odds ratio = 6.15; 95% CI, 1.39–27.15; I<sup>2</sup> = 80%). Posttreatment vitreous hemorrhage, vitrectomy, and increased intraocular pressure events were similar between the anti-VEGF and combination groups compared with PRP; however, macular edema results favored the anti-VEGF over the PRP group. Using the GRADE assessment, BCVA evidence was rated to be of moderate certainty, whereas CMT and NVT evidence certainty was rated as very low.</div></div><div><h3>Conclusion</h3><div>Anti-VEGF and combination treatments could be regarded as alternative approaches to PRP alone in the management of PDR after engaging in a shared decision-making process based on patients’ adherence, diabetic
{"title":"Anti-VEGF Injections vs. Panretinal Photocoagulation Laser Therapy for Proliferative Diabetic Retinopathy","authors":"Marie-Michele Macaron BSc , Nader Al Sabbakh BSc , M Zaid Shami MD , Dennis Akrobetu MD , Natalie E. Bourdakos BSc , Fatma A.M. Abdulsalam MBBS , Hayato Nakanishi MBBS, MS , Christian A. Than MBBS, PhD , Sophie J. Bakri MD","doi":"10.1016/j.oret.2024.08.004","DOIUrl":"10.1016/j.oret.2024.08.004","url":null,"abstract":"<div><h3>Topic</h3><div>To evaluate the efficacy and safety of anti-VEGF and panretinal photocoagulation (PRP) for the treatment of proliferative diabetic retinopathy (PDR). The outcomes examined are changes in best-corrected visual acuity (BCVA), neovascularization (NV), central macular thickness (CMT), and adverse outcomes.</div></div><div><h3>Clinical relevance</h3><div>Diabetic retinopathy is the leading cause of blindness in working-aged adults globally. At present, no consensus has been reached on the optimal choice for the treatment of PDR.</div></div><div><h3>Methods</h3><div>Cochrane, Embase, PubMed, Scopus, Web of Science, and CiNAHL were searched for articles from their inception to June 2023 according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis. The review was registered prospectively with PROSPERO (CRD42023437778). Tool data analysis was performed using RevMan software version 5.4 (Review Manager [RevMan] [computer program], The Cochrane Collaboration, 2020). Randomized control trials (RCTs) of PDR patients treated with anti-VEGF, PRP, or a combination were included. Risk of bias was assessed using the Rob2 assessment tool (revised tool for risk of bias in randomized trials), and certainty of evidence was assessed with the Grading Recommendations Assessment, Development and Evaluation (GRADE) approach.</div></div><div><h3>Results</h3><div>Nineteen studies were included, with 1361 patients (n = 1788 eyes) treated for PDR with either anti-VEGF (n = 274), PRP (n = 482), or combination (n = 320). Our results show more favorable BCVA outcomes with anti-VEGF compared with PRP at 3 months (mean difference [MD] = 2.35 letters; 95% confidence interval [CI], 1.18–3.52; I<sup>2</sup> = 0%) and 12 months follow-up (MD = 3.39 letters; 95% CI, 0.63–6.14; I<sup>2</sup> = 26%). Combination treatment showed better BCVA outcomes compared with PRP at 12 months (MD = 4.06 letters; 95% CI, 0.26–7.86; I<sup>2</sup> = 0%). Combination showed lower CMT at 3 months (MD = −33.10 μm; 95% CI, −40.12 to −26.08; I<sup>2</sup> = 25%) and 6 months (MD = −34.28 μm; 95% CI, −55.59 to −12.97; I<sup>2</sup> = 85%) compared with PRP, but CMT results were similar at 12 months. Complete regression of total NV (NVT) was more likely with anti-VEGF compared with PRP (odds ratio = 6.15; 95% CI, 1.39–27.15; I<sup>2</sup> = 80%). Posttreatment vitreous hemorrhage, vitrectomy, and increased intraocular pressure events were similar between the anti-VEGF and combination groups compared with PRP; however, macular edema results favored the anti-VEGF over the PRP group. Using the GRADE assessment, BCVA evidence was rated to be of moderate certainty, whereas CMT and NVT evidence certainty was rated as very low.</div></div><div><h3>Conclusion</h3><div>Anti-VEGF and combination treatments could be regarded as alternative approaches to PRP alone in the management of PDR after engaging in a shared decision-making process based on patients’ adherence, diabetic","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 105-121"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141917223","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.08.007
Grace S. Yin MD, MPhil , Zhuo Shao MDCM, PhD , Hanna Faghfoury MDCM, FRCPC , Brian G. Ballios MD, PhD
Objective
To investigate the ability of a new clinical model to improve accessibility and expedite the pathway to molecular diagnosis for patients with suspected inherited retinal diseases (IRDs).
Design
Retrospective cohort study of electronic patient records.
Participants
All patients referred to general medical genetic clinic between September 2017 and September 2019 and an ophthalmologist-led IRD clinic between October 2021 and July 2023 for suspected IRD were included.
Methods
The difference in timeliness and accessibility to diagnosis and genetics testing for patients referred for suspected IRDs were compared based on whether they were referred to a general medical genetics clinic or an ophthalmologist-led IRD clinic.
Main Outcome Measures
The primary outcomes were time to consult from referral; time from initial consult to molecular diagnosis; and the time from initial consult to genetics result disclosure and counseling. Secondary outcomes included number of prior providers investigating the chief complaint, the proportion of patients undergoing genetics testing, and the range of diagnostic investigations undertaken.
Results
Four hundred seventy-three patients were included, with 212 cases from a general medical genetics clinic and 261 from a medical retina clinic. The mean time from referral to initial consult was 14 months (±3.33 months) and 4 months (±3.4 months) for the general medical genetics and the ophthalmologist-led IRD clinics, respectively. The mean time from initial consult to genetics disclosure and counseling was 6 months (±3.6 months) and 3.5 months (±1.8 months) for the medical genetics and the ophthalmologist-led models, respectively. The total time from initial referral to genetics disclosure and counseling for the medical geneticist-led clinic model was 20 to 24 months. The total time from initial referral to genetics disclosure and counseling for the ophthalmologist-led retinal clinic was 5 to 8 months. The average number of prior providers seen before presenting to the ophthalmologist-led retina clinic was 2.05 (range, 1–10).
Conclusions
Shifting from the traditional medical genetics model to the new ophthalmologist-led IRD clinical model may improve accessibility and expedite the pathway to molecular diagnosis and subsequent gene therapy trials for patients with suspected IRDs.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Streamlined Ophthalmologist-Led Pathway to Diagnosis and Accessibility of Genetics Testing for Patients with Inherited Retinal Dystrophies in Canada","authors":"Grace S. Yin MD, MPhil , Zhuo Shao MDCM, PhD , Hanna Faghfoury MDCM, FRCPC , Brian G. Ballios MD, PhD","doi":"10.1016/j.oret.2024.08.007","DOIUrl":"10.1016/j.oret.2024.08.007","url":null,"abstract":"<div><h3>Objective</h3><div>To investigate the ability of a new clinical model to improve accessibility and expedite the pathway to molecular diagnosis for patients with suspected inherited retinal diseases (IRDs).</div></div><div><h3>Design</h3><div>Retrospective cohort study of electronic patient records.</div></div><div><h3>Participants</h3><div>All patients referred to general medical genetic clinic between September 2017 and September 2019 and an ophthalmologist-led IRD clinic between October 2021 and July 2023 for suspected IRD were included.</div></div><div><h3>Methods</h3><div>The difference in timeliness and accessibility to diagnosis and genetics testing for patients referred for suspected IRDs were compared based on whether they were referred to a general medical genetics clinic or an ophthalmologist-led IRD clinic.</div></div><div><h3>Main Outcome Measures</h3><div>The primary outcomes were time to consult from referral; time from initial consult to molecular diagnosis; and the time from initial consult to genetics result disclosure and counseling. Secondary outcomes included number of prior providers investigating the chief complaint, the proportion of patients undergoing genetics testing, and the range of diagnostic investigations undertaken.</div></div><div><h3>Results</h3><div>Four hundred seventy-three patients were included, with 212 cases from a general medical genetics clinic and 261 from a medical retina clinic. The mean time from referral to initial consult was 14 months (±3.33 months) and 4 months (±3.4 months) for the general medical genetics and the ophthalmologist-led IRD clinics, respectively. The mean time from initial consult to genetics disclosure and counseling was 6 months (±3.6 months) and 3.5 months (±1.8 months) for the medical genetics and the ophthalmologist-led models, respectively. The total time from initial referral to genetics disclosure and counseling for the medical geneticist-led clinic model was 20 to 24 months. The total time from initial referral to genetics disclosure and counseling for the ophthalmologist-led retinal clinic was 5 to 8 months. The average number of prior providers seen before presenting to the ophthalmologist-led retina clinic was 2.05 (range, 1–10).</div></div><div><h3>Conclusions</h3><div>Shifting from the traditional medical genetics model to the new ophthalmologist-led IRD clinical model may improve accessibility and expedite the pathway to molecular diagnosis and subsequent gene therapy trials for patients with suspected IRDs.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 180-186"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142000441","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.10.009
Jonathan C. Tsui MD, Brian L. VanderBeek MD, MSCE
{"title":"Providing for Proliferative Diabetic Retinopathy in Our Neighborhoods","authors":"Jonathan C. Tsui MD, Brian L. VanderBeek MD, MSCE","doi":"10.1016/j.oret.2024.10.009","DOIUrl":"10.1016/j.oret.2024.10.009","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 95-97"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143133668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.08.011
Tugche S. Chen MD(c) , Yasmin Motekalem MD(c) , Isabela Martins Melo MD , Roxane J. Hillier MD , Alan R. Berger MD , Louis R. Giavedoni MD , David T. Wong MD, FRCSC , Filiberto Altomare MD , Rajeev H. Muni MD, MSc
Purpose
To assess long-term redetachment rates of the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).
Design
Randomized controlled trial.
Subjects
PIVOT trial participants.
Methods
This study was performed at St. Michael’s Hospital, Unity Health Toronto, Toronto, Canada. PIVOT trial participants who had undergone either pneumatic retinopexy (PnR) or pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD) repair with a minimum follow-up of 2 years were assessed for long-term redetachment by chart review or telephone interview. The latter was the only accepted method for those with <2 years of follow-up. Patients were only eligible if no reintervention to reattach the retina was performed within the first year of the initial procedure.
Main Outcome Measures
Long-term redetachment rates for PnR vs. PPV after RRD repair.
Results
Sixty-one participants who underwent PPV and 62 who underwent PnR were analyzed. The long-term redetachment rates were 0% and 1.61% (1/62) in the PPV and PnR groups, respectively (P = 0.32). The mean follow-up duration in years was 5.43 ± 3.60 vs. 5.51 ± 3.03 in the PPV and PnR groups, respectively.
Conclusions
There was no statistically significant difference in long-term redetachment rates for PnR vs. PPV. Both procedures are durable treatment options for RRD over an extended period, rarely requiring additional intervention for redetachment.
Financial Disclosure(s)
The author(s) have no proprietary or commercial interest in any materials discussed in this article.
目的：评估气动视网膜剥离术与玻璃体切割术治疗原发性风湿性视网膜脱落结果随机试验（PIVOT）的长期再脱落率：设计：随机对照试验：方法：本研究在加拿大多伦多 Unity Health 多伦多圣迈克尔医院进行。通过病历审查或电话访谈的方式，对接受过气动视网膜修复术或ppv术进行rd修复的PIVOT试验参与者进行长期再脱落评估。对于随访时间不足两年的患者，后者是唯一可接受的方法。只有在初次手术后的第一年内未再次进行视网膜粘连干预的患者才符合条件：主要结果指标：RRD修复术后，气动视网膜剥离术与ppv术的长期再脱落率：结果：分析了61名ppv参与者和62名气动视网膜修复参与者。ppv组和气动视网膜修复组的长期再脱落率分别为0%和1.61%（1/62）（p= 0.32）。ppv组和气动视网膜修复组的平均随访时间分别为5.43+/-3.60年和5.51+/-3.03年：结论：气动视网膜剥脱术与ppv术的长期再脱落率在统计学上没有明显差异。这两种手术都是长期治疗视网膜脱落的持久方法，很少需要额外的再脱落干预。
{"title":"Long-Term Redetachment Rates of Pneumatic Retinopexy versus Pars Plana Vitrectomy in Retinal Detachment","authors":"Tugche S. Chen MD(c) , Yasmin Motekalem MD(c) , Isabela Martins Melo MD , Roxane J. Hillier MD , Alan R. Berger MD , Louis R. Giavedoni MD , David T. Wong MD, FRCSC , Filiberto Altomare MD , Rajeev H. Muni MD, MSc","doi":"10.1016/j.oret.2024.08.011","DOIUrl":"10.1016/j.oret.2024.08.011","url":null,"abstract":"<div><h3>Purpose</h3><div>To assess long-term redetachment rates of the Pneumatic Retinopexy versus Vitrectomy for the Management of Primary Rhegmatogenous Retinal Detachment Outcomes Randomized Trial (PIVOT).</div></div><div><h3>Design</h3><div>Randomized controlled trial.</div></div><div><h3>Subjects</h3><div>PIVOT trial participants.</div></div><div><h3>Methods</h3><div>This study was performed at St. Michael’s Hospital, Unity Health Toronto, Toronto, Canada. PIVOT trial participants who had undergone either pneumatic retinopexy (PnR) or pars plana vitrectomy (PPV) for rhegmatogenous retinal detachment (RRD) repair with a minimum follow-up of 2 years were assessed for long-term redetachment by chart review or telephone interview. The latter was the only accepted method for those with <2 years of follow-up. Patients were only eligible if no reintervention to reattach the retina was performed within the first year of the initial procedure.</div></div><div><h3>Main Outcome Measures</h3><div>Long-term redetachment rates for PnR vs. PPV after RRD repair.</div></div><div><h3>Results</h3><div>Sixty-one participants who underwent PPV and 62 who underwent PnR were analyzed. The long-term redetachment rates were 0% and 1.61% (1/62) in the PPV and PnR groups, respectively (<em>P</em> = 0.32). The mean follow-up duration in years was 5.43 ± 3.60 vs. 5.51 ± 3.03 in the PPV and PnR groups, respectively.</div></div><div><h3>Conclusions</h3><div>There was no statistically significant difference in long-term redetachment rates for PnR vs. PPV. Both procedures are durable treatment options for RRD over an extended period, rarely requiring additional intervention for redetachment.</div></div><div><h3>Financial Disclosure(s)</h3><div>The author(s) have no proprietary or commercial interest in any materials discussed in this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 122-126"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142056219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.05.021
Peter A. Campochiaro MD , David Eichenbaum MD , Margaret A. Chang MD, MS , W. Lloyd Clark MD , Jordan M. Graff MD , Sophie Le Pogam PhD , Melina Cavichini Cordeiro MD, MS , Shamika Gune MD, MS , Mel Rabena BS , Natasha Singh PharmD, RPh , Stephanie Lin PhD , Natalia Callaway MD, MS
Objective
The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration (nAMD). Portal (NCT03683251) is evaluating long-term safety and tolerability of the PDS in patients with nAMD who completed the phase II Ladder (NCT02510794) or phase III Archway (NCT03677934) trials.
All-PDS safety population (N = 555) comprises patients enrolled in Portal who completed Ladder or Archway. Because of data availability, efficacy population comprises Ladder-to-Portal patients only: patients who previously received PDS 10, 40, or 100 mg/mL pro re nata (as-needed [PRN]; n = 58, 62, and 59, respectively) or monthly intravitreal ranibizumab 0.5-mg injections (monthly ranibizumab; n = 41) in Ladder and subsequently enrolled in Portal.
Methods
Ladder patients received PDS refill-exchanges PRN or monthly ranibizumab. Archway patients received PDS 100 mg/mL with fixed refill-exchanges every 24 weeks (Q24W) or monthly ranibizumab. Once enrolled in Portal, all patients receive PDS Q24W from day 1.
Main Outcome Measures
Ocular adverse events of special interest (AESIs); changes from baseline in best-corrected visual acuity (BCVA) and center point thickness (CPT); supplemental ranibizumab treatment between refill-exchange procedures; and PDS Patient Preference Questionnaire results.
Results
In the All-PDS safety population (mean follow-up, 111 weeks), 137 (24.7%) patients had ≥1 ocular AESI; most common were cataract (11.4%), vitreous hemorrhage (6.1%), and conjunctival thickening (bleb)/filtering bleb leak (6.3%). Endophthalmitis occurred in 11 of 555 (2.0%) patients. For Ladder-to-Portal patients previously treated with PDS 100 mg/mL or monthly ranibizumab, BCVA remained stable from baseline to month 48; mean (95% confidence interval) changes from baseline were 0.1 (−6.6 to 6.8; n = 31) and 2.3 (−9.4 to 14.1; n = 15) letters, respectively; CPT remained stable through month 48. Approximately 95% of patients did not need supplemental treatment before each refill-exchange for >2 years since Portal enrollment. Of Ladder-to-Portal previous monthly ranibizumab patients, 92% preferred the PDS over injections.
Conclusions
Interim results from Portal suggest 4-year maintenance of visual/anatomic outcomes with PDS 100 mg/mL, with the PDS preferred to monthly injections. Long-term safety profile of the PDS is well characterized.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Interim Results of the Phase III Portal Extension Trial of the Port Delivery System with Ranibizumab in Neovascular Age-Related Macular Degeneration","authors":"Peter A. Campochiaro MD , David Eichenbaum MD , Margaret A. Chang MD, MS , W. Lloyd Clark MD , Jordan M. Graff MD , Sophie Le Pogam PhD , Melina Cavichini Cordeiro MD, MS , Shamika Gune MD, MS , Mel Rabena BS , Natasha Singh PharmD, RPh , Stephanie Lin PhD , Natalia Callaway MD, MS","doi":"10.1016/j.oret.2024.05.021","DOIUrl":"10.1016/j.oret.2024.05.021","url":null,"abstract":"<div><h3>Objective</h3><div>The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration (nAMD). Portal (NCT03683251) is evaluating long-term safety and tolerability of the PDS in patients with nAMD who completed the phase II Ladder (NCT02510794) or phase III Archway (NCT03677934) trials.</div></div><div><h3>Design</h3><div>Multicenter, nonrandomized, open-label, extension clinical trial.</div></div><div><h3>Participants</h3><div>All-PDS safety population (N = 555) comprises patients enrolled in Portal who completed Ladder or Archway. Because of data availability, efficacy population comprises Ladder-to-Portal patients only: patients who previously received PDS 10, 40, or 100 mg/mL pro re nata (as-needed [PRN]; n = 58, 62, and 59, respectively) or monthly intravitreal ranibizumab 0.5-mg injections (monthly ranibizumab; n = 41) in Ladder and subsequently enrolled in Portal.</div></div><div><h3>Methods</h3><div>Ladder patients received PDS refill-exchanges PRN or monthly ranibizumab. Archway patients received PDS 100 mg/mL with fixed refill-exchanges every 24 weeks (Q24W) or monthly ranibizumab. Once enrolled in Portal, all patients receive PDS Q24W from day 1.</div></div><div><h3>Main Outcome Measures</h3><div>Ocular adverse events of special interest (AESIs); changes from baseline in best-corrected visual acuity (BCVA) and center point thickness (CPT); supplemental ranibizumab treatment between refill-exchange procedures; and PDS Patient Preference Questionnaire results.</div></div><div><h3>Results</h3><div>In the All-PDS safety population (mean follow-up, 111 weeks), 137 (24.7%) patients had ≥1 ocular AESI; most common were cataract (11.4%), vitreous hemorrhage (6.1%), and conjunctival thickening (bleb)/filtering bleb leak (6.3%). Endophthalmitis occurred in 11 of 555 (2.0%) patients. For Ladder-to-Portal patients previously treated with PDS 100 mg/mL or monthly ranibizumab, BCVA remained stable from baseline to month 48; mean (95% confidence interval) changes from baseline were 0.1 (−6.6 to 6.8; n = 31) and 2.3 (−9.4 to 14.1; n = 15) letters, respectively; CPT remained stable through month 48. Approximately 95% of patients did not need supplemental treatment before each refill-exchange for >2 years since Portal enrollment. Of Ladder-to-Portal previous monthly ranibizumab patients, 92% preferred the PDS over injections.</div></div><div><h3>Conclusions</h3><div>Interim results from Portal suggest 4-year maintenance of visual/anatomic outcomes with PDS 100 mg/mL, with the PDS preferred to monthly injections. Long-term safety profile of the PDS is well characterized.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Pages 144-155"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142110359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-01DOI: 10.1016/j.oret.2024.07.001
Matteo Menean MD, Ayman G. Elnahry MD, PhD, Basil K. Williams Jr MD
{"title":"Bifocal Circumscribed Choroidal Hemangioma","authors":"Matteo Menean MD, Ayman G. Elnahry MD, PhD, Basil K. Williams Jr MD","doi":"10.1016/j.oret.2024.07.001","DOIUrl":"10.1016/j.oret.2024.07.001","url":null,"abstract":"","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":"9 2","pages":"Page e14"},"PeriodicalIF":4.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141793029","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}
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