ArticleOphthalmology science2026
Pharmacodynamics of Free VEGF After Treatment with the Port Delivery Platform with Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration.
Article in Ophthalmology science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II, Multicenter, Randomized, Active Treatment-Controlled Study of the Efficacy and Safety of the Ranibizumab Port Delivery System for Sustained Delivery of Ranibizumab in Patients With Subfoveal Neovascular Age-Related Macular Degeneration
Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-Comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration
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4 authors.
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Abstract
Objective: To evaluate the pharmacodynamics of aqueous humor (AH) free VEGF concentrations after treatment with the Port Delivery Platform with ranibizumab (PDS) in patients with neovascular age-related macular degeneration (nAMD). Design: Pharmacokinetic and pharmacodynamic analyses from the phase III Archway (NCT03677934) and phase II Ladder (NCT02510794) trials. Participants: Patients with treatment-responsive nAMD. Methods: In Archway, patients received PDS 100 mg/mL with refills every 24 weeks (Q24W) or intravitreal ranibizumab 0.5 mg every 4 weeks (Q4W) for 96 weeks. In Ladder, patients received PDS 10, 40, or 100 mg/mL with refills based on protocol-defined criteria or intravitreal ranibizumab 0.5 mg Q4W. Aqueous humor samples were collected throughout the trials (PDS arms only in Ladder) in a subset of patients. Main Outcome Measures: Aqueous humor ranibizumab and free VEGF concentrations. Results: Archway analyses included 1149 AH samples from 215 patients. Ladder analyses included 109 AH samples from 47 patients. Aqueous humor ranibizumab concentrations after treatment with the PDS were consistent with the PDS implant release rate. Median AH free VEGF concentrations at randomization (on average 3 weeks after intravitreal ranibizumab injection) were 8.46 and 7.26 pg/mL in the PDS 100 mg/mL and intravitreal ranibizumab Q4W arms, respectively. Throughout the trial, AH free VEGF concentrations remained suppressed in both arms relative to previously reported values from treatment-naïve patients, and AH free VEGF concentrations 24 weeks after treatment with PDS 100 mg/mL Q24W were similar to or lower than those 4 weeks after treatment with intravitreal ranibizumab. In Ladder, analysis of limited samples suggests there was a tendency for a delayed loss of AH free VEGF suppression with increasing ranibizumab dose. Below AH ranibizumab concentrations of ∼10 Conclusions: These findings demonstrate that PDS 100 mg/mL Q24W suppresses AH free VEGF throughout the entire 24-week refill-exchange interval and to an extent similar to that at 4 weeks after intravitreal ranibizumab. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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