Discussing how end of study results from the phase 2 LADDER trial inform clinicians on the use of PDS with ranibizumab.
While anti-VEGF therapies have transformed the treatment of wet age-related macular degeneration (wAMD), the associated treatment burden of regular injections remains a hurdle for many patients.
As a natural result of this obstacle, potential therapies that could alleviate this burden, such as the Port Delivery System with ranibizumab (PDS), are met with equal amounts of anticipation and expectations from ophthalmologists.
Recent data regarding the potential wAMD therapy, which was due to be presented at the 2020 Association for Research in Vision and Ophthalmology (ARVO) annual meeting, explored the end of study results from the phase 2 LADDER program.
Briefly, the phase 2 LADDER study (NCT02510794) enrolled a total of 220 patients who randomized in a 3:3:3:2 ratio to PDS with 10 mg/mL, 40 mg/mL, and 100 mg/mL formulations of ranibizumab or intravitreal injection of ranibizumab 0.5 mg monthly. Mean time on study was 22.1 months and mean time to first refill was 8.7 months, 13.0 months, and 15.8 months for the PDS 10 mg, 40 mg, and 100 mg/mL arms, respectively.
“The reassuring news from this study is that there were no new safety signals—that the adverse event profile was still very low and was consistent with what we had seen from the interim analysis and the primary analysis,” said Franco Recchia, MD, vitreoretinal specialist with Tennessee Retina, in an interview with HCPLive®.
End of study results indicated 59.4% of patients in the 100 mg/mL group did not meet refill criteria at month 12 compared to 56% in the 40 mg/mL group, and 28.9% in the 100 mg/mL group. Results of a comparison between the 100 mg/mL group and the monthly ranibizumab group indicated a mean gain of 2.9 and 2.7 letters in best-corrected visual acuity, respectively. Additionally, there were no additional dose-related serious adverse events observed in this analysis.
For additional insight into the topic and how the data from this study inform clinicians on the use of PDS with ranibizumab, check out our interview with Recchia below.