To the Editor:
A recent letter by Campochiaro et al. highlights the errors in our previous manuscript titled “Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases.” We like to thank Dr Campochiaro et al. for their comments and will address them individually in this letter.
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(1)
Regarding the primary analysis of the Phase II LADDER trial, we thank the authors of the letter for pointing out that the Port Delivery System (PDS) 100 mg/ml arm had a median, not mean, refill time of 15.0 months.
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(2)
During the submission of the manuscript on the 21 August 2019, the estimated completion date of the Phase III ARCHWAY trial (ClinicalTrials.gov NCT03677934) was stated as May 2022 on ClinicalTrials.gov. A revision of the completion date to April 2021 was submitted on 25 October 2019 [1] after manuscript submission (History of Changes for Study: NCT03677934).
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(3)
The authors of the review understood that the PORTAL trial (ClinicalTrials.gov NCT03683251) is an extension of the LADDER or ARCHWAY trials.
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(4)
We understand that the wording used by us was confusing with respect to the periodicity of refills. A more precise wording should have been used to highlight that participants receive refills every 24 weeks during the trial for up to 144 weeks instead of 24 week periodic refills.
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(5)
Finally, during the submission of the manuscript, once again the estimated completion of the PORTAL extension trial was stated as June 2022 on ClinicalTrials.gov. However, a revision of the completion date to January 2022 was submitted on 25 October 2019 [2] after submission of our manuscript (History of Changes for Study: NCT03683251).
In our paper, we stated that the PDS is a novel and promising prolonged-release platform. We continue to stand by this opinion. Furthermore, we highlighted that further improvements are being made to the PDS to reduce complications. Your letter has very kindly provided us with greater insights on these improvements. We agree that the PDS is a system which can potentially change the way neovascular age related macular degeneration is treated. Many ophthalmologists globally will be awaiting the safety and efficacy data from the ARCHWAY trial this year.
References
Medicine UNLo. History of Changes for Study: NCT03677934. A phase III study to evaluate the Port Delivery System with ranibizumab compared with monthly ranibizumab injections in participants with wet age-related macular degeneration (Archway). Medicine UNLo; 2020. https://clinicaltrials.gov/ct2/history/NCT03677934. Accessed Apr 27 2020.
Medicine UNLo. History of Changes for Study: NCT03683251. Extension study for the Port Delivery System with ranibizumab (Portal). Medicine UNLo; 2020. https://clinicaltrials.gov/ct2/history/NCT03683251?V_10=View. Accessed Apr 27 2020.
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Seah, I., Zhao, X.X., Lin, Q. et al. Response to ‘Comment on: “Use of biomaterials for sustained delivery of anti-VEGF to treat retinal diseases”’. Eye 35, 1026–1027 (2021). https://doi.org/10.1038/s41433-020-0983-0
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DOI: https://doi.org/10.1038/s41433-020-0983-0