David A. Eichenbaum MD , William R. Freeman MD , Margaret A. Chang MD, MS , Logan Brooks MD , Nauman Chaudhry MD , Hajir Dadgostar MD, PhD , Colin A. McCannel MD , Mark Michels MD , Robert A. Mittra MD , Jeremy D. Wolfe MD, MS , Victoria C. Beindl MS , Philip Jaycock FRCOphth, MD , Ashwini Bobbala MS , Shamika Gune MD, MS , Galin Spicer MD, MBA , Natalia Callaway MD, MS
{"title":"使用雷珠单抗门给药系统治疗的眼内炎:临床试验开发期间的病例摘要。","authors":"David A. Eichenbaum MD , William R. Freeman MD , Margaret A. Chang MD, MS , Logan Brooks MD , Nauman Chaudhry MD , Hajir Dadgostar MD, PhD , Colin A. McCannel MD , Mark Michels MD , Robert A. Mittra MD , Jeremy D. Wolfe MD, MS , Victoria C. Beindl MS , Philip Jaycock FRCOphth, MD , Ashwini Bobbala MS , Shamika Gune MD, MS , Galin Spicer MD, MBA , Natalia Callaway MD, MS","doi":"10.1016/j.oret.2024.08.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration. The United States Prescribing Information has a Boxed Warning for endophthalmitis and reports the incidence rate in patients developing endophthalmitis after receiving the PDS compared with monthly intravitreal ranibizumab. Endophthalmitis cases noted in the Boxed Warning, treatment outcomes, potential contributing factors, and potential mitigations are summarized.</div></div><div><h3>Design</h3><div>Retrospective review of endophthalmitis cases in PDS-treated patients in the phase II Ladder (NCT02510794) and phase III Archway (NCT03677934) and Portal (NCT03683251) trials.</div></div><div><h3>Participants</h3><div>Endophthalmitis cases in the pooled all-PDS safety population (N = 555) including PDS patients in Ladder, Archway, or Portal.</div></div><div><h3>Methods</h3><div>Ladder patients received PDS (10, 40, or 100 mg/ml) with pro re nata refill-exchanges. Archway patients received PDS 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W). Portal patients received PDS Q24W from day 1.</div></div><div><h3>Main Outcome Measures</h3><div>Clinical features, management, and visual outcomes were summarized. Cases were summarized by date of PDS implant and/or refill, other prior invasive procedures/refills, and preceding/concurrent conjunctival complications.</div></div><div><h3>Results</h3><div>Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021. All were cultured (3 were culture positive) and treated with intravitreal antibiotics. Two cases (2/555 [0.4%]) occurred in the immediate postoperative period (days 5 and 6). Nine cases occurred later (day range: 57–853), including 4 before the first refill-exchange (day range: 57–161). Five patients received between 1 and 11 refill-exchanges before the event (onset: 6–168 days after last refill-exchange). Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications. At last follow-up, 7 patients recovered vision to study baseline levels or ≥20/40; 4 patients experienced vision loss of ≥15 ETDRS letters.</div></div><div><h3>Conclusions</h3><div>Endophthalmitis is a serious complication that can endanger vision after any ocular procedure, including PDS implantation. Most, but not all, of this limited series of endophthalmitis cases were late onset, associated with conjunctival breach, and recovered vision with treatment. Meticulous attention to PDS surgical techniques with vigilant monitoring of conjunctiva during follow-up may minimize risk of endophthalmitis. Prompt treatment is critical for optimizing patient outcomes.</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 127-143"},"PeriodicalIF":4.4000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab\",\"authors\":\"David A. Eichenbaum MD , William R. Freeman MD , Margaret A. Chang MD, MS , Logan Brooks MD , Nauman Chaudhry MD , Hajir Dadgostar MD, PhD , Colin A. McCannel MD , Mark Michels MD , Robert A. Mittra MD , Jeremy D. Wolfe MD, MS , Victoria C. Beindl MS , Philip Jaycock FRCOphth, MD , Ashwini Bobbala MS , Shamika Gune MD, MS , Galin Spicer MD, MBA , Natalia Callaway MD, MS\",\"doi\":\"10.1016/j.oret.2024.08.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration. The United States Prescribing Information has a Boxed Warning for endophthalmitis and reports the incidence rate in patients developing endophthalmitis after receiving the PDS compared with monthly intravitreal ranibizumab. Endophthalmitis cases noted in the Boxed Warning, treatment outcomes, potential contributing factors, and potential mitigations are summarized.</div></div><div><h3>Design</h3><div>Retrospective review of endophthalmitis cases in PDS-treated patients in the phase II Ladder (NCT02510794) and phase III Archway (NCT03677934) and Portal (NCT03683251) trials.</div></div><div><h3>Participants</h3><div>Endophthalmitis cases in the pooled all-PDS safety population (N = 555) including PDS patients in Ladder, Archway, or Portal.</div></div><div><h3>Methods</h3><div>Ladder patients received PDS (10, 40, or 100 mg/ml) with pro re nata refill-exchanges. Archway patients received PDS 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W). Portal patients received PDS Q24W from day 1.</div></div><div><h3>Main Outcome Measures</h3><div>Clinical features, management, and visual outcomes were summarized. Cases were summarized by date of PDS implant and/or refill, other prior invasive procedures/refills, and preceding/concurrent conjunctival complications.</div></div><div><h3>Results</h3><div>Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021. All were cultured (3 were culture positive) and treated with intravitreal antibiotics. Two cases (2/555 [0.4%]) occurred in the immediate postoperative period (days 5 and 6). Nine cases occurred later (day range: 57–853), including 4 before the first refill-exchange (day range: 57–161). Five patients received between 1 and 11 refill-exchanges before the event (onset: 6–168 days after last refill-exchange). Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications. At last follow-up, 7 patients recovered vision to study baseline levels or ≥20/40; 4 patients experienced vision loss of ≥15 ETDRS letters.</div></div><div><h3>Conclusions</h3><div>Endophthalmitis is a serious complication that can endanger vision after any ocular procedure, including PDS implantation. Most, but not all, of this limited series of endophthalmitis cases were late onset, associated with conjunctival breach, and recovered vision with treatment. Meticulous attention to PDS surgical techniques with vigilant monitoring of conjunctiva during follow-up may minimize risk of endophthalmitis. Prompt treatment is critical for optimizing patient outcomes.</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. 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Retina","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468653024003683","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Endophthalmitis in Eyes Treated with the Port Delivery System with Ranibizumab
Purpose
The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration. The United States Prescribing Information has a Boxed Warning for endophthalmitis and reports the incidence rate in patients developing endophthalmitis after receiving the PDS compared with monthly intravitreal ranibizumab. Endophthalmitis cases noted in the Boxed Warning, treatment outcomes, potential contributing factors, and potential mitigations are summarized.
Design
Retrospective review of endophthalmitis cases in PDS-treated patients in the phase II Ladder (NCT02510794) and phase III Archway (NCT03677934) and Portal (NCT03683251) trials.
Participants
Endophthalmitis cases in the pooled all-PDS safety population (N = 555) including PDS patients in Ladder, Archway, or Portal.
Methods
Ladder patients received PDS (10, 40, or 100 mg/ml) with pro re nata refill-exchanges. Archway patients received PDS 100 mg/ml with fixed refill-exchanges every 24 weeks (PDS Q24W). Portal patients received PDS Q24W from day 1.
Main Outcome Measures
Clinical features, management, and visual outcomes were summarized. Cases were summarized by date of PDS implant and/or refill, other prior invasive procedures/refills, and preceding/concurrent conjunctival complications.
Results
Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021. All were cultured (3 were culture positive) and treated with intravitreal antibiotics. Two cases (2/555 [0.4%]) occurred in the immediate postoperative period (days 5 and 6). Nine cases occurred later (day range: 57–853), including 4 before the first refill-exchange (day range: 57–161). Five patients received between 1 and 11 refill-exchanges before the event (onset: 6–168 days after last refill-exchange). Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications. At last follow-up, 7 patients recovered vision to study baseline levels or ≥20/40; 4 patients experienced vision loss of ≥15 ETDRS letters.
Conclusions
Endophthalmitis is a serious complication that can endanger vision after any ocular procedure, including PDS implantation. Most, but not all, of this limited series of endophthalmitis cases were late onset, associated with conjunctival breach, and recovered vision with treatment. Meticulous attention to PDS surgical techniques with vigilant monitoring of conjunctiva during follow-up may minimize risk of endophthalmitis. Prompt treatment is critical for optimizing patient outcomes.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.