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

Abstract

Importance: The port delivery system (PDS) with ranibizumab has demonstrated noninferior and equivalent efficacy compared with monthly intravitreal injections of ranibizumab, an anti-vascular endothelial growth factor (VEGF) agent, in patients with neovascular age-related macular degeneration (nAMD), but evaluating patient preference is important to help inform clinical decision-making.

Objective: Evaluate treatment satisfaction for ranibizumab delivered via PDS vs intravitreal injections as well as patient preference among those assigned to PDS.

Design, setting, and participants: Archway was a phase 3 randomized active-comparator open-label clinical trial conducted at 78 sites in the US. Patients 50 years and older with nAMD diagnosed within 9 months of screening with a documented response to anti-VEGF therapy were included. Of 619 patients screened, 418 were enrolled; 415 were included in the primary analysis and 234 were included in the secondary exploratory analysis. The Archway study ran from September 12, 2019, through primary readout on May 22, 2020.

Interventions: Patients were randomized 3:2 to PDS with ranibizumab, 100 mg/mL, with fixed refill exchanges every 24 weeks or intravitreal ranibizumab injections, 0.5 mg, every 4 weeks.

Main outcomes and measures: Treatment satisfaction was measured using the Macular Disease Treatment Satisfaction Questionnaire in the PDS and intravitreal injection arms at week 40. Patient preference was assessed using the content-validated PDS Patient Preference Questionnaire (PPPQ), which measured the proportion of patients in the PDS arm with monthly monitoring who preferred treatment with the PDS at week 40 over previous intravitreal injections or concurrent fellow-eye injections. Both outcomes were exploratory end points.

Results: The mean (SD) age of participants at baseline was 75.0 (7.9) years; 234 participants (59%) were women and 162 (41%) were men. At week 40, differences in overall treatment satisfaction scores were minimal for the PDS and intravitreal injection arms (mean, 68.0; 95% CI, 67.4-68.6; n = 237 and mean, 66.1; 95% CI, 64.9-67.3; n = 159, respectively; difference, 1.9; 95% CI, 0.7-3.1). A total of 234 of 248 patients (94.4%) in the PDS arm were included in the PPPQ analysis. At week 40, almost all patients in the PDS arm preferred treatment via PDS (218 of 234 [93.2%]) vs previous intravitreal injections (3 of 234 [1.3%]), including 172 of 234 (73.5%) with a very strong preference for the PDS. In patients who received concurrent fellow-eye injections (n = 78), 72 (92.3%) preferred the PDS.

Conclusions and relevance: Although PDS treatment was preferred by almost all patients assigned to PDS over previous intravitreal injections, both delivery methods have high treatment satisfaction. These findings provide further evidence for the PDS as a meaningful alternative treatment option for patients with nAMD.

Trial registration: ClinicalTrials.gov Identifier: NCT03677934.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Chang reported nonfinancial writing support from Genentech during the conduct of the study; nonfinancial support from Allergan, Genentech, Mylan, NGM Biopharmaceuticals, Novartis, Ophthea, Ophthotech, and Regeneron; and personal fees from Genentech and REGENXBIO outside the submitted work. Ms Kapre, Dr Kaufman, Dr Kardatzke, Mr Rabena, Ms Patel, Ms Bobbala, Dr Gune, Dr Fung, and Dr Wallenstein reported being employees of Genentech. No other disclosures were reported.

Figures

Figure 1.. Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) Overall Treatment Satisfaction and Subscale Scores for Ranibizumab Via the Port Delivery System (PDS) vs Intravitreal Delivery

The overall MacTSQ score is on a scale of 1 to 72, with scores of at least 60 indicating high satisfaction. Each MacTSQ subscale is on a scale of 1 to 36, with scores of at least 30 indicating high satisfaction. Error bars represent 95% CIs.

Figure 2.. Patient Flow Diagram for the Exploratory Analysis of the Port Delivery System (PDS) Patient Preference Questionnaire (PPPQ)

aDetails of the primary analysis of Archway have been published elsewhere. bPatients in the intravitreal ranibizumab group were not included in the exploratory analysis for PPPQ.

Figure 3.. Treatment Strength of Preference for the Port Delivery System (PDS) Patient Preference Questionnaire

For patients with missing week-40 values, the last postbaseline observation was used. Percentages are based on the total number of patients who completed the measure (n = 234).

Figure 4.. Reason for Treatment Preference in Patients in the Port Delivery System (PDS) Arm as Assessed by the PDS Patient Preference Questionnaire

Patients could select multiple reasons for their preference. For patients with missing week-40 values, the last postbaseline observation was used. Percentages are based on the total number of patients who completed the measure (n = 234).