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Richard F Dreyer, Melvin Rabena, Giulio Barteselli, Fan Tang, Betsy Tschosik; Patient experience data from the phase 2 Ladder trial of the Port Delivery System with ranibizumab. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5388.
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© ARVO (1962-2015); The Authors (2016-present)
The Port Delivery System with ranibizumab (PDS) is a novel, investigational, surgically implanted, refillable intraocular implant designed for continuous delivery of a customized formulation of ranibizumab. Understanding the treatment experience from the patient’s perspective will aid clinical decision-making for individualized patient care. The purpose of this analysis was to evaluate patient treatment satisfaction in the ongoing phase 2 Ladder randomized controlled trial (NCT02510794) in the PDS 100 mg/mL and monthly intravitreal ranibizumab 0.5 mg injection arms.
Ladder was designed to characterize the efficacy, durability, and safety of the PDS in patients with neovascular AMD responsive to anti-VEGF treatment. Treatment satisfaction was measured at baseline and months 1, 6, and 9 with the Macular Degeneration Treatment Satisfaction Questionnaire (MacTSQ). MacTSQ measures overall satisfaction with macular degeneration treatment; total scores range from 0–72 (≥ 60 = high satisfaction). Subscales were (1) Information Provision and Convenience and (2) Impact of Treatment; each subscale scored from 0–36 (≥ 30 = high satisfaction).
As reported previously, vision outcomes were comparable in the PDS 100 mg/mL and monthly intravitreal ranibizumab arms despite an expected initial temporary drop in PDS patients after surgery. During 16.4 months on study, PDS 100 mg/mL patients received a mean of 2.4 ranibizumab treatments compared with 16.8 ranibizumab treatments for patients in the monthly intravitreal ranibizumab arm. Patients had high overall satisfaction with both treatments (Table). Differences in satisfaction between groups were driven by a trend toward higher scores on the Impact of Treatment subscale in the PDS 100 mg/mL patients.
Ladder MacTSQ data indicate that treatment with PDS 100 mg/mL and monthly intravitreal ranibizumab result in high overall treatment satisfaction through 9 months of treatment. The high satisfaction, on average, in the PDS 100 mg/mL arm at month 1 suggests that PDS surgical implantation does not have a negative effect on average satisfaction, despite the temporary drop in vision. Data variability is noted. The MacTSQ will be included in the PDS phase 3 Archway trial (NCT03677934), along with a patient preference questionnaire, to more fully describe the patient treatment experience.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
Table: Ladder Trial MacTSQ Scores
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