Veeral S Sheth, Nancy M Holekamp, Arshad M Khanani, Aleksandra Rachitskaya, Steven Blotner, Shamika Gune, Dominic Heinrich, Katie F Maass, Usha Chakravarthy
{"title":"使用拉尼珠单抗的端口给药系统与每月注射拉尼珠单抗的 Archway 试验中的视网膜液和厚度波动。","authors":"Veeral S Sheth, Nancy M Holekamp, Arshad M Khanani, Aleksandra Rachitskaya, Steven Blotner, Shamika Gune, Dominic Heinrich, Katie F Maass, Usha Chakravarthy","doi":"10.1016/j.oret.2024.10.015","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.</p><p><strong>Design: </strong>Post hoc analyses of phase 3 Archway trial (NCT03677934).</p><p><strong>Participants: </strong>Adults with nAMD responsive to anti-VEGF therapy.</p><p><strong>Intervention: </strong>Four hundred eighteen patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks.</p><p><strong>Outcomes: </strong>Proportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1 mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA.</p><p><strong>Results: </strong>Four hundred fifteen eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96, respectively. BCVA changes from baseline to week 96 were -1.1 letters with the PDS versus -1.4 with monthly ranibizumab in eyes with SRF/IRF, and -1.9 versus -1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were -2.1 with the PDS versus -6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] vs. 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were -2.5 versus -2.6 (mean BCVA at 96 weeks 72.7 [20/35] vs. 71.5 [20/38]).</p><p><strong>Conclusions: </strong>Port Delivery System with ranibizumab Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. Retina","volume":" ","pages":""},"PeriodicalIF":4.4000,"publicationDate":"2024-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections.\",\"authors\":\"Veeral S Sheth, Nancy M Holekamp, Arshad M Khanani, Aleksandra Rachitskaya, Steven Blotner, Shamika Gune, Dominic Heinrich, Katie F Maass, Usha Chakravarthy\",\"doi\":\"10.1016/j.oret.2024.10.015\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.</p><p><strong>Design: </strong>Post hoc analyses of phase 3 Archway trial (NCT03677934).</p><p><strong>Participants: </strong>Adults with nAMD responsive to anti-VEGF therapy.</p><p><strong>Intervention: </strong>Four hundred eighteen patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks.</p><p><strong>Outcomes: </strong>Proportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1 mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA.</p><p><strong>Results: </strong>Four hundred fifteen eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96, respectively. BCVA changes from baseline to week 96 were -1.1 letters with the PDS versus -1.4 with monthly ranibizumab in eyes with SRF/IRF, and -1.9 versus -1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were -2.1 with the PDS versus -6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] vs. 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were -2.5 versus -2.6 (mean BCVA at 96 weeks 72.7 [20/35] vs. 71.5 [20/38]).</p><p><strong>Conclusions: </strong>Port Delivery System with ranibizumab Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>\",\"PeriodicalId\":19501,\"journal\":{\"name\":\"Ophthalmology. 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Retinal Fluid and Thickness Fluctuations in Archway Trial for Port Delivery System with Ranibizumab versus Monthly Ranibizumab Injections.
Purpose: To determine proportion of eyes with neovascular age-related macular degeneration (nAMD) with retinal fluid and central subfield thickness (CST) fluctuations and evaluate their impact on best-corrected visual acuity (BCVA) in eyes treated with the Port Delivery System with ranibizumab (PDS) versus monthly intravitreal ranibizumab injections.
Design: Post hoc analyses of phase 3 Archway trial (NCT03677934).
Participants: Adults with nAMD responsive to anti-VEGF therapy.
Intervention: Four hundred eighteen patients randomized 3:2 to the PDS (100 mg/mL) with refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab (0.5 mg) for 96 weeks.
Outcomes: Proportion of eyes in each treatment arm with subretinal and/or intraretinal fluid (SRF/IRF) overall and in central 1 mm; BCVA changes from baseline by treatment arm and fluid presence/location; proportion of eyes with CST fluctuations from baseline to week 48, week 48 to 96, and baseline to week 96; effects of CST fluctuations on BCVA.
Results: Four hundred fifteen eyes were assessed. In the PDS versus monthly ranibizumab arm, proportion of eyes with SRF/IRF, central SRF, and central IRF were 47.6% versus 50.9%, 29.0% versus 19.2%, and 11.7% versus 12.6% at baseline, and 57.8% versus 56.1%, 21.6% versus 14.8%, and 7.0% versus 8.4% at week 96, respectively. BCVA changes from baseline to week 96 were -1.1 letters with the PDS versus -1.4 with monthly ranibizumab in eyes with SRF/IRF, and -1.9 versus -1.8 in eyes with central SRF. In eyes with central IRF, BCVA changes from baseline to week 96 were -2.1 with the PDS versus -6.9 with monthly ranibizumab, respectively (mean BCVA at 96 weeks 68.9 [20/40] vs. 64.6 [20/50]). CST fluctuations occurred in 32.1% and 29.7% of PDS versus monthly ranibizumab eyes; corresponding BCVA changes from baseline to week 96 were -2.5 versus -2.6 (mean BCVA at 96 weeks 72.7 [20/35] vs. 71.5 [20/38]).
Conclusions: Port Delivery System with ranibizumab Q24W maintained BCVA to 96 weeks regardless of SRF/IRF, central SRF, central IRF, or CST fluctuations, comparable with monthly ranibizumab, thus supporting the use of the PDS in stabilizing retinal anatomy without the need for monthly treatment in patients with nAMD.
Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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