Reducing Treatment Burden for Age-Related Macular Degeneration Patients: A Systematic Review of Ranibizumab Port Delivery System Oral Presentation - Observational Study - General practitioner
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Ranibizumab port delivery system, neovascular age related macular degeneration
Abstract
Introduction & Objectives
Ranibizumab port delivery system (PDS) is a newly developed method that provides a continuous,
long-term supply of ranibizumab into the vitreous, reducing the burden of monthly intravitreal
injection visits for neovascular age-related macular degeneration (nAMD) patients. This review aims
to evaluate the efficacy and safety of ranibizumab PDS in nAMD.
Methods
An extensive literature search was performed on 4 online databases: PubMed, Cochrane, ProQuest,
and ScienceDirect. The inclusion criteria are human studies comparing ranibizumab port delivery
system and intravitreal ranibizumab, English language, with full-text journal available. The main
outcome measurements are best-corrected visual acuity (BCVA) in Early Treatment Diabetic
Retinopathy Study (ETDRS) letters, central foveal thickness (CFT), and adverse events.
Results
Two randomized controlled trials (RCTs) with a total of 638 adults were evaluated. At week 96,
ranibizumab PDS reported observed mean BCVA changes from baseline (-1.0; +4.2; ETDRS letters)
compared to monthly intravitreal ranibizumab (-1.1; +6.1; ETDRS letters). However, there was an
increase in mean CFT changes from baseline (+9.9; +22.3 vs ?1.3; ?35.8, ?m) and severe adverse
events frequency (22; 4 vs 4; 0) with ranibizumab PDS versus monthly intravitreal ranibizumab,
respectively.
Conclusion
Ranibizumab PDS showed comparable visual outcomes to intravitreal ranibizumab while
demonstrating inferior anatomical outcomes and higher incidence of severe adverse effects. Despite
this, with fewer treatment visits required for up to 24 weeks, ranibizumab PDS can potentially
reduce the treatment burden in nAMD patients with poor compliance. Further studies are needed to
provide better patient eligibility guidelines and recommendations for adverse event management of
ranibizumab PDS.
Full text article
References
Brown DM, Heier JS, Ciulla T, Benz M, Abraham P, Yancopoulos G, et al. Primary Endpoint Results of a Phase II Study of Vascular Endothelial Growth Factor Trap-Eye in Wet Age-related Macular Degeneration. Ophthalmology. 2011;118:1089–97.
Campochiaro PA, Marcus DM, Awh CC, Regillo C, Adamis AP, Bantseev V, 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;126:1141–54.
Boyer DS, Yoon YH, Belfort R, Bandello F, Maturi RK, Augustin AJ, et al. Three-year, randomized, shamcontrolled trial of dexamethasone intravitreal implant in patients with diabetic macular edema. Ophthalmology. 2014;121:1904–14.
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan—a web and mobile app for systematic reviews. Systematic Reviews. 2016;5:210.
Khanani AM, Callanan D, Dreyer R, Chen S, Howard JG, Hopkins JJ, et al. End-of-Study Results for the Ladder Phase 2 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2021;5:775–87.
Regillo C, Berger B, Brooks L, Clark WL, Mittra R, Wykoff CC, et al. Archway Phase 3 Trial of the Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration 2-Year Results. Ophthalmology. 2023;S0161-6420(23)00135-5.
Vukicevic M, Heraghty J, Cummins R, Gopinath B, Mitchell P. Caregiver perceptions about the impact of caring for patients with wet age-related macular degeneration. Eye (Lond). 2016;30:413–21.
Sugar EA, Jabs DA, Altaweel MM, Lightman S, Acharya N, Vitale AT, et al. Identifying a clinically meaningful threshold for change in uveitic macular edema evaluated by optical coherence tomography. Am J Ophthalmol. 2011;152:1044-1052.e5.
Riva I, Roberti G, Oddone F, Konstas AG, Quaranta L. Ahmed glaucoma valve implant: surgical technique and complications. Clin Ophthalmol. 2017;11:357–67.
Budenz DL, Feuer WJ, Barton K, Schiffman J, Costa VP, Godfrey DG, et al. Postoperative Complications in the Ahmed Baerveldt Comparison Study During Five Years of Follow-up. Am J Ophthalmol. 2016;163:75-82.e3.
Ho AC, Busbee BG, Regillo CD, Wieland MR, Everen SAV, Li Z, et al. Twenty-four-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-Related Macular Degeneration. Ophthalmology. 2014;121:2181–92.
Daien V, Nguyen V, Essex RW, Morlet N, Barthelmes D, Gillies MC, et al. Incidence and Outcomes of Infectious and Noninfectious Endophthalmitis after Intravitreal Injections for Age-Related Macular Degeneration. Ophthalmology. 2018;125:66–74.
Awh CC, Barteselli G, Makadia S, Chang RT, Stewart JM, Wieland MR, et al. Management of Key Ocular Adverse Events in Patients Implanted with the Port Delivery System with Ranibizumab. Ophthalmol Retina. 2022;6:1028–43.
Pieramici DJ, Heimann F, Brassard R, Barteselli G, Ranade S. Virtual Reality Becomes a Reality for Ophthalmologic Surgical Clinical Trials. Transl Vis Sci Technol. 2020;9:1.
Chang MA, Kapre A, Kaufman D, Kardatzke DR, Rabena M, Patel S, et al. Patient Preference and Treatment Satisfaction With a Port Delivery System for Ranibizumab vs Intravitreal Injections in Patients With Neovascular AgeRelated Macular Degeneration. JAMA Ophthalmol. 2022;140:771–8.
Authors
Copyright (c) 2023 Dewa Ayu Anggi Paramitha, Ajeng Kartika Ayu Putri, Seruni Hanna Ardhia, Jovita Jutamulia
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