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• W4247674013 abstract "We thank Sharma et al for their interest in the Port Delivery System with ranibizumab (PDS) and their astute observations on the primary analysis results from the Ladder phase 2 clinical trial, in which the median time to first implant refill was 15 months and 80% of patients went 6 months or longer until first implant refill in the PDS 100-mg/ml arm.1Campochiaro P.A. Marcus D.M. Awh C.C. et al.The Port Delivery System with ranibizumab for neovascular age-related macular degeneration: results from the randomized phase 2 Ladder clinical trial.Ophthalmology. 2019; 126: 1141-1154Abstract Full Text Full Text PDF PubMed Scopus (166) Google Scholar First, the implant is designed to release ranibizumab following first-order kinetics. The 3 doses for the dose-ranging Ladder phase 2 trial were selected based on a pharmacokinetics–visual acuity model used to simulate the Ladder trial design and estimate time to first refill for the selected doses. Of note, the Ladder trial was not specifically powered to detect statistically significant differences between the PDS 40- and 100-mg/ml treatment arms. Instead, the Ladder trial was powered to detect differences between the PDS 10- and 100-mg/ml treatment arms and the PDS 10- and 40-mg/ml treatment arms. Second, a history of vitrectomy was an exclusion criterion for entry into the Ladder phase 2 trial. The phase 3 Archway trial (NCT03677934), which is currently ongoing, also excludes eyes with history of vitrectomy from enrollment. There may be opportunities to study the behavior of the PDS in patients with a history of vitrectomy in the future. Third, additional evidence regarding the impact of oral antithrombotic therapy on implant insertion outcomes is currently being collected in the ongoing phase 3 Archway trial. Patients taking oral antithrombotic therapy are eligible to enroll if they can safely temporarily interrupt treatment at least 1 day before implant insertion. The duration of treatment interruption will be determined by the investigator in consultation with the prescribing physician. The authors recognize the burden posed by the need for frequent anti–vascular endothelial growth factor injections on patients and caregivers. We are optimistic about the potential of the PDS to help address this unmet need and look forward to sharing both longer-term data from the phase 2 Ladder trial, and the results of the phase 3 Archway trial, upon their completion. Re: Campochiaro et al.: The Port Delivery System with ranibizumab for neovascular age-related macular degeneration: results from the randomized phase 2 Ladder clinical trial (Ophthalmology. 2019;126:1141-1154)OphthalmologyVol. 126Issue 11PreviewCampochiaro et al compare a new formulation of ranibizumab in 10, 40, and 100 mg/ml concentration being delivered into the intravitreal cavity via a new refillable port delivery system (PDS) with a US Food and Drug Administration–approved formulation of 0.5 mg ranibizumab in a 10 mg/ml concentration delivered via monthly intravitreal injection. The authors conclude that the 100 mg/ml solution of a PDS is similar in efficacy to monthly dosing regimen and >80% patients in the trial could go beyond 6 months without needing a pro re nata refill. Full-Text PDF" @default.
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• W4247674013 date "2019-11-01" @default.
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• W4247674013 doi "https://doi.org/10.1016/j.ophtha.2019.06.020" @default.
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