Safety Data Sheets:
The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).
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Publications and Congresses
The information in this section may include content beyond what is in the FDA-approved label. Because the FDA has not approved such content, no conclusions regarding safety or efficacy may be made. Providing this information should not be construed as recommendation for use of a Genentech product for unapproved uses. For FDA-approved products please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product(s) for its approved indication(s).
Publications: The list of publications is not an exhaustive list of published materials on the product. The list of references by data topics is selected per evidence-based medicine criteria. To browse a full listing of published scientific literature:
Congresses: The list of congresses is a subset of Roche/Genentech posters and oral presentations for the product with data presented at scientific meetings in the recent 24 months. To browse full Roche/Genentech congress presentations and posters:
Showing 37 out of 37 results
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20240816 Endophthalmitis in Eyes Treated With the Port Delivery System With Ranibizumab: Summary of Cases During Clinical Trial Development
Eichenbaum DA, Freeman WR, Chang MA, et al. Endophthalmitis in Eyes Treated With the Port Delivery System With Ranibizumab: Summary of Cases During Clinical Trial Development. Ophthalmology Retina. 2024; In Press, Corrected Proof, Available online 16 August 2024.Pivotal Trial(s) -
20240201 Exudation in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System or Monthly Injections
Akhlaq A, Williams D, Clark WL, et al. Exudation in Patients With Neovascular Age-Related Macular Degeneration Treated With the Port Delivery System or Monthly Injections. American Journal of Ophthalmology. 2024; 258: 158-172.Exploratory Analysis -
20240101 Stability of Ranibizumab during Continuous Delivery from the Port Delivery Platform
Hieb AR, Horvath J, Rea J, et al. Stability of Ranibizumab during Continuous Delivery from the Port Delivery Platform. Journal of Controlled Release 366 (2024) 170–181.Pharmacokinetics (PK) and Pharmacodynamics (PD) -
202307 Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results
Regillo C, Berger B, Brooks L, et al. Ophthalmology2023;130:735-747Pivotal Trial(s) -
20230428 Long-term Efficacy and Safety of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration: Results From the Portal 5-Year Subgroup Analysis
Howard J, Cavichini M, Singh N, et al. Long-term Efficacy and Safety of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration: Results From the Portal 5-Year Subgroup Analysis. Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2023.Supportive Studies -
20230227 Key Surgical Pearls for Best Practice During the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure
Yoon YH, Wieland M, Jaycock P, et al. Key Surgical Pearls for Best Practice During the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure. Presented at the 38th Asia-Pacific Academy of Ophthalmology Congress Kuala Lumpur, MalaysiaSupportive Studies -
20230227 Portal Extension Trial of the Port Delivery System With Ranibizumab (PDS): Three-Year Follow-Up From the Phase 3 Archway Trial
Hwang D, Regillo CD, Blotner S, et al. Portal Extension Trial of the Port Delivery System With Ranibizumab (PDS): Three-Year Follow-Up From the Phase 3 Archway Trial. Presented at the 38th Asia-Pacific Academy of Ophthalmology Congress Kuala Lumpur, MalaysiaExploratory Analysis -
20221121 Key Surgical Pearls for Best Practice During the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure
Okada M, Wieland M, Jaycock P, et al. Key Surgical Pearls for Best Practice During the Port Delivery System With Ranibizumab (PDS) Implant Insertion Procedure. Presented at the 15th Congress of the Asia-Pacific Vitreo-retina Society Taipei, TaiwanSupportive Studies -
20221121 End-of-Study Retinal Fluid and Vision Outcomes in the 96-week Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Lai TYY, Rachitskaya A, Blotner S, et al. End-of-Study Retinal Fluid and Vision Outcomes in the 96-week Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With Neovascular Age-related Macular Degeneration (nAMD). Presented at the 15th Congress of the Asia-Pacific Vitreo-retina Society Taipei, TaiwanExploratory Analysis -
20221121 Central Subfield Thickness Fluctuations and Their Impact on Vision Outcomes Over 96 Weeks in the Archway Trial of the Port Delivery System With Ranibizumab (PDS)
Hwang YS, Chakravarthy U, Blotner S, et al. Central Subfield Thickness Fluctuations and Their Impact on Vision Outcomes Over 96 Weeks in the Archway Trial of the Port Delivery System With Ranibizumab (PDS). Presented at the 15th Congress of the Asia-Pacific Vitreo-retina Society Taipei, TaiwanExploratory Analysis -
20221121 Supplemental Intravitreal Ranibizumab Injections in Patients With the Port Delivery System With Ranibizumab (PDS) in the Phase 3 Archway Trial for Neovascular Age-Related Macular Degeneration (nAMD)
Chang A, Pieramici D, Gune S, et al. Supplemental Intravitreal Ranibizumab Injections in Patients With the Port Delivery System With Ranibizumab (PDS) in the Phase 3 Archway Trial for Neovascular Age-Related Macular Degeneration (nAMD). Presented at the 15th Congress of the Asia-Pacific Vitreo-retina Society Taipei, TaiwanExploratory Analysis -
20221120 Portal Extension Trial of the Port Delivery System With Ranibizumab (PDS): Three-Year Follow-Up From the Phase 3 Archway Trial
Chen SJ, Regillo CD, Blotner S, et al. Portal Extension Trial of the Port Delivery System With Ranibizumab (PDS): Three-Year Follow-Up From the Phase 3 Archway Trial. Presented at the 15th Congress of the Asia-Pacific Vitreo-retina Society Taipei, TaiwanSupportive Studies -
20221107 Supplemental Intravitreal Ranibizumab Injections in Patients With the Port Delivery System With Ranibizumab (PDS)
Pieramici D, Gune S, DeGraaf S, et al. Supplemental Intravitreal Ranibizumab Injections in Patients With the Port Delivery System With Ranibizumab (PDS). Presented at the 55th Retina Society Annual Scientific MeetingExploratory Analysis -
20221107 Key Pearls of the Refill-Exchange Procedure for the Port Delivery System With Ranibizumab
Dhoot D, Khanani AM, Singh N, et al. Key Pearls of the Refill-Exchange Procedure for the Port Delivery System With Ranibizumab. Presented at the 55th Retina Society Annual Scientific MeetingSupportive Studies -
20221004 Port Delivery System Long-term Portal Extension Data: Three-Year Follow-up From the Phase 3 Archway Study
Regillo CD. Port Delivery System Long-term Portal Extension Data: Three-Year Follow-up From the Phase 3 Archway Study. Presented at the 2022 Annual Meeting of the American Academy of OphthalmologyExploratory Analysis -
20220801 Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial
Chang M, Kapre A, Kaufman D, et al. Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol 2022;140:771-778.Exploratory Analysis -
20220516 Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab
Awh CC, Barteselli G, Makadia S, et al. Management of Key PDS Ocular Adverse Events. Ophthalmology 2022;129(12):1336-1341Safety -
20220505 Mittra R, Brooks L, Wykoff CC, et al. Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) for Neovascular AMD: End-of-Study Results
Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) for Neovascular AMD: End-of-Study Results. Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022. Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022.Pivotal Trial(s) -
20220502 Implant Insertion Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Pearls
Pieramici DJ, Wieland MR, Stewart JM, et al. Implant Insertion Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Pearls. Ophthalmic Surg Lasers Imaging Retina. 2022;53:249-256.Pivotal Trial(s) -
20220501 Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience
Khanani AM, Graff JM, Marcus DM, et al. Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience. Ophthalmic Surg Lasers Imaging Retina. 2022;53:257-265.Pivotal Trial(s) -
20220501 Conjunctiva and Tenon’s Capsule Handling in the Port Delivery System with Ranibizumab Implant Insertion Procedure: Surgical Pearls
Graff JM, Sheth VS, Chang RT, et al. Conjunctiva and Tenon’s Capsule Handling in the Port Delivery System with Ranibizumab Implant Insertion Procedure: Surgical Pearls. Ophthalmic Surg Lasers Imaging Retina. 2022;53:266-273.Safety -
20220501 Key Clinical Pearls for Evaluating Surgical Candidates, and Patient Preference, for the Port Delivery System with Ranibizumab (PDS)
Holekamp NM, Bobbala A, Callaway N, et al. Key Clinical Pearls for Evaluating Surgical Candidates, and Patient Preference, for the Port Delivery System with Ranibizumab (PDS). Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022.Supportive Studies -
20220501 Interim analysis of the Portal extension trial evaluating the long-term safety and efficacy of the Port Delivery System with ranibizumab (PDS) in neovascular age-related macular degeneration (nAMD)
Haug S, Callaway N, DeGraaf S, et al. Interim analysis of the Portal extension trial evaluating the long-term safety and efficacy of the Port Delivery System with ranibizumab (PDS) in neovascular age-related macular degeneration (nAMD). Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022.Supportive Studies -
20220430 Drug release kinetics of the Port Delivery System with ranibizumab (PDS): platform technology for continuous retinal drug delivery
Horvath J, Maass KF, Ranade SV, et al. Drug release kinetics of the Port Delivery System with ranibizumab (PDS): platform technology for continuous retinal drug delivery. Presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2022.Pharmacokinetics (PK) and Pharmacodynamics (PD) -
20220301 Archway Randomized Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration
Holekamp N, Campochiaro P, Chang M, et al. Archway Randomized Phase 3 Trial of the Port Delivery SystemPivotal Trial(s) -
20220214 2-Year Outcomes From the Phase 3 Archway Trial: Management of Neovascular Age-Related Macular Degeneration Using the Port Delivery System With Ranibizumab (PDS)
Wykoff CC. 2-Year Outcomes From the Phase 3 Archway Trial: Management of Neovascular Age-Related Macular Degeneration Using the Port Delivery System With Ranibizumab (PDS). Presented at Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 –Virtual EditionExploratory Analysis -
20220214 Long-term (+ 3-Year) Safety and Efficacy Data for the Port Delivery System: Interim Analysis Results of the Portal Extension Study of the Port Delivery System With Ranibizumab (PDS) in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Eichenbaum D. Long-term (+ 3-Year) Safety and Efficacy Data for the Port Delivery System: Interim Analysis Results of the Portal Extension Study of the Port Delivery System With Ranibizumab (PDS) in Patients With Neovascular Age-Related Macular Degeneration (nAMD). Presented at Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration 2022 –Virtual EditionSafety -
20211212 The Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Neovascular Age-Related Macular Degeneration: Updated Results and Analysis of Retinal Fluid and Vision Outcomes
Sheu SJ, Fung AE, Barteselli G, et al. The Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Neovascular Age-Related Macular Degeneration: Updated Results and Analysis of Retinal Fluid and Vision Outcomes. Presented at the 14th Congress of the Asia-Pacific Vitreo-retina Society (APVRS). December 12, 2021.Exploratory Analysis -
20211212 Key Surgical Pearls of the Implant Insertion Procedure for the Port Delivery System With Ranibizumab (PDS)
Chang A, Singh N, Barteselli G, et al. Key Surgical Pearls of the Implant Insertion Procedure for the Port Delivery System With Ranibizumab (PDS). Presented at the 14th Congress of the Asia-Pacific Vitreo-retina Society (APVRS). December 12, 2021.Supportive Studies -
20211115 Interim Analysis Results of the Phase 3 Portal Trial Evaluating the Long-Term Safety and Efficacy of the Port Delivery System With Ranibizumab (PDS) for Patients With Neovascular Age-related Macular Degeneration (nAMD)
Campochiaro PA. Interim Analysis Results of the Phase 3 Portal Trial Evaluating the Long-Term Safety and Efficacy of the Port Delivery System With Ranibizumab (PDS) for Patients With Neovascular Age-related Macular Degeneration (nAMD). Presented at the Annual Meeting of the American Academy of Ophthalmology Retina Subspecialty Day (AAO-SSD 2021). November 15, 2021.Supportive Studies -
20211021 Pharmacokinetic Profile of the Port Delivery System With Ranibizumab (PDS) in the Phase 2 Ladder Trial and Phase 3 Archway Trial
Maass KF, Gune S, Maia M, et al. Pharmacokinetic Profile of the Port Delivery System With Ranibizumab (PDS) in the Phase 2 Ladder Trial and Phase 3 Archway Trial. Presented at the American Association of Pharmaceutical Scientists. October 21, 2021.Exploratory Analysis -
20211012 Pharmacokinetic Profile of the Port Delivery System With Ranibizumab in the Phase 3 Archway Trial
Kitchens JW, Gune S, Maia M, et al. Pharmacokinetic Profile of the Port Delivery System With Ranibizumab in the Phase 3 Archway Trial. Presented at the 39th Annual Meeting of the American Society of Retina Specialists. October 12, 2021.Exploratory Analysis -
20211012 Analysis of Retinal Fluid and Vision Outcomes in the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With nAMD
Khanani AM, Blotner S, Gune S, et al. Analysis of Retinal Fluid and Vision Outcomes in the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With nAMD. Presented atthe 39th Annual Meeting of the American Society of Retina Specialists. October 12, 2021.Exploratory Analysis -
20211012 Updated Safety and Efficacy Results From the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) for Neovascular AMD
Awh CC, Barteselli G, Fung AE, et al. Updated Safety and Efficacy Results From the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) for Neovascular AMD. Presented at the 39th Annual Meeting of the American Society of Retina Specialists. October 12, 2021.Safety -
20211004 The Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) for Neovascular AMD: Updated Safety and Efficacy Results
Clark WK, Barteselli G, Fung AE, et al. Presented at Retina Society 2021. October 4, 2021Exploratory Analysis -
20210912 Analysis of Retinal Fluid and Vision Outcomes in the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With nAMD
Khanani AM, Blotner S, Gune S, et al. Analysis of Retinal Fluid and Vision Outcomes in the Archway Phase 3 Trial of the Port Delivery System With Ranibizumab (PDS) in Patients With nAMD. Presented at Asia-Pacific Academy of Ophthalmology 2021. September 12, 2021Exploratory Analysis -
20210912 Pharmacokinetic Profile of the Port Delivery System With Ranibizumab (PDS) in the Phase 2 Ladder Trial and Phase 3 Archway Trial in Patients with Neovascular Age-Related Macular Degeneration
Cheung G, Gune S, Maia M, et al. Pharmacokinetic Profile of the Port Delivery System With Ranibizumab (PDS) in the Phase 2 Ladder Trial and Phase 3 Archway Trial in Patients with Neovascular Age-Related Macular Degeneration. Presented at Asia-Pacific Academy of Ophthalmology 2021. September 12, 2021Exploratory Analysis
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