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
NCT03677934 | ARCHWAY | Chang M et al. (2022)
Chang, M. A., Kapre, A., Kaufman, D., Kardatzke, D. R., Rabena, M., Patel, S., Bobbala, A., Gune, S., Fung, A., Wallenstein, G. 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(8):771-778.
Locations
78 sites in the United States
Study Period
September 2019 – May 2020
Study Design
Phase 3, randomized, open-label, active-comparator trial
Study Population
Experimental Group
Control Group
Follow-up Time: 40 weeks
Outcomes
Durability
Not reported
Vision
Not reported
Other
Patients’ Satisfaction :
Treatment Satisfaction Score (MacTSQ)
Total treatment satisfaction scores at 40 weeks (Primary outcome):
• PDS: Mean = 68.0 (95% CI: 67.4-68.6) in 237 patients
• IV Ranibizumab: Mean = 66.1 (95% CI: 64.9-67.3) in = 159 patients
• Difference = 1.9 (95% CI: 0.7-3.1).
Subscale: Treatment Convenience and Information
• PDS: Mean = 34.7 (95% CI: 34.4-34.9) in 228 patients
• IV Ranibizumab: Mean = 34.1 (95% CI: 33.6-34.7) in 155 patients
• Difference = 0.6 (95% CI: -0.1 to 1.2).
Subscale: Impact of Treatment
• PDS: Mean = 33.4 (95% CI: 32.9-33.8) in 237 patients
• IV Ranibizumab: Mean = 32.0 (95% CI: 31.2-32.7) in 159 patients
• Difference = 1.4 (95% CI: 0.6-2.2).
Patient Preference (PPPQ)
• 218/234 (93.2%) preferred PDS
• 3/234 (1.3%) preferred IV injections
• 13/234 (5.6%) had no preference.
• Among patients receiving fellow-eye IV injections, 72/78 (92.3%) preferred PDS.
Immunognicity
Not reported
Pharmokinetics
Not reported
Anatomic
Not reported
Safety
Treatment-emergent AEs
Not separately reported
Ocular-related AEs (Study Eye)
Not separately reported
Non-ocular AEs
Not separately reported
Conclusion
Although both treatment methods had high patient satisfaction, nearly all patients preferred the PDS over intravitreal injections. These findings support the PDS as a viable alternative for managing nAMD.
Risk of Bias Assessment for Primary Outcome
Randomization Process
Low risk
Note: From the Appendix: “Randomization will be performed through an IxRS”. #“Overall patient demographics were well balanced across treatment arms.”
Missing Outcome Data
Low risk
Note: Missingness for each group was balanced and less than 5%. In addition, subscale analysis acted as a sensitivity analysis, which confirmed the primary analysis.
Selection of the Reported Results
Low risk Note: protocol was attached.
Deviations from Intended Observations
Some concerns Note: The patients and the personnel were aware of the interventions, but there was no information on whether deviations arose because of the trial context. According to Figure 1 and Table, the per-protocol principle (inappropriate analysis) was applied. However, the missingness is less than 5%.
Measurement of the Outcome
High risk Note: The primary outcome of this paper is patient-reported outcomes. However, patients are aware of the interventions (masking is impossible). There is no information on if the assessment (MacTSQ was influenced by knowledge of intervention.
Overall
High risk
Categories: Wet AMD