Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience

Arshad M. Khanani; Jordan M. Graff; Dennis M. Marcus; Charles C. Wykoff; Chirag D. Jhaveri; Giulio Barteselli; Varun K. Malhotra; Alicia R. Menezes; Natalia F. Callaway

doi:10.3928/23258160-20220412-01

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience

Arshad M. Khanani, Jordan M. Graff, Dennis M. Marcus, Charles C. Wykoff, Chirag D. Jhaveri, Giulio Barteselli, Varun K. Malhotra, Alicia R. Menezes, Natalia F. Callaway

Research output: Contribution to journal › Article › peer-review

8 Scopus citations

Abstract

PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases.

Original language	English (US)
Pages (from-to)	257-265
Number of pages	9
Journal	Ophthalmic Surgery Lasers and Imaging Retina
Volume	53
Issue number	5
DOIs	https://doi.org/10.3928/23258160-20220412-01
State	Published - May 2022

ASJC Scopus subject areas

Surgery
Ophthalmology

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@article{bd55b6a06d3d45f4947fce316c358668,

title = "Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience",

abstract = "PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases.",

author = "Khanani, {Arshad M.} and Graff, {Jordan M.} and Marcus, {Dennis M.} and Wykoff, {Charles C.} and Jhaveri, {Chirag D.} and Giulio Barteselli and Malhotra, {Varun K.} and Menezes, {Alicia R.} and Callaway, {Natalia F.}",

note = "Funding Information: Acknowledgements: The authors wish to acknowledge Anne E. Fung, MD, for critical review of and insights into the manuscript. Medical writing assistance was provided by Alexandra Niemczura, PhD, with Meditech Media, Ltd., with funding support from Genentech, Inc., a member of the Roche Group. This research was presented as part of an oral presentation at the 44th Macula Society 2021 Meeting; February 6-7, 2021. Publisher Copyright: {\textcopyright} 2022 Khanani, Graff, Marcus, et al.",

year = "2022",

month = may,

doi = "10.3928/23258160-20220412-01",

language = "English (US)",

volume = "53",

pages = "257--265",

journal = "Ophthalmic Surgery Lasers and Imaging Retina",

issn = "2325-8160",

publisher = "Slack Incorporated",

number = "5",

}

TY - JOUR

T1 - Refill-Exchange Procedure of the Port Delivery System With Ranibizumab

T2 - Overview and Clinical Trial Experience

AU - Khanani, Arshad M.

AU - Graff, Jordan M.

AU - Marcus, Dennis M.

AU - Wykoff, Charles C.

AU - Jhaveri, Chirag D.

AU - Barteselli, Giulio

AU - Malhotra, Varun K.

AU - Menezes, Alicia R.

AU - Callaway, Natalia F.

N1 - Funding Information: Acknowledgements: The authors wish to acknowledge Anne E. Fung, MD, for critical review of and insights into the manuscript. Medical writing assistance was provided by Alexandra Niemczura, PhD, with Meditech Media, Ltd., with funding support from Genentech, Inc., a member of the Roche Group. This research was presented as part of an oral presentation at the 44th Macula Society 2021 Meeting; February 6-7, 2021. Publisher Copyright: © 2022 Khanani, Graff, Marcus, et al.

PY - 2022/5

Y1 - 2022/5

N2 - PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases.

AB - PURPOSE: To describe the Port Delivery System with ranibizumab refill-exchange procedure. METHODS: Procedure based on the clinical trial program in patients with retinal diseases. RESULTS: The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts. CONCLUSION: The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases.

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VL - 53

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JO - Ophthalmic Surgery Lasers and Imaging Retina

JF - Ophthalmic Surgery Lasers and Imaging Retina

IS - 5

ER -

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience

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