Phase II of the Ladder clinical trial recently found that the Port Delivery System (PDS) with ranibizumab for wet AMD has good potential for reducing the treatment burden while maintaining vision. These results support the trial’s preliminary findings. The PDS is an implantable reservoir that is filled with ranibizumab for continuous release over a period of time, as an alternative to a regimen of frequent injections.
The multicenter, randomized, active treatment-controlled trial included 220 patients with AMD and a documented response to anti-VEGF. Patients were randomized to PDS treatment doses of 10mg/mL, 40mg/mL or 100mg/mL or monthly intravitreal ranibizumab injections of 0.5mg.
At the end of the 22-month study, the researchers reported improvements in best-corrected visual acuity in all groups. The median time to the first refill of the PDS was 8.7, 13.0 and 15.8 months, respectively, for the three PDS dosing groups. Additionally, 29%, 56% and 60% of the PDS groups, respectively, went 12 months or longer without needing a refill.
The investigators observed a similar mean central foveal thickness change from baseline in the PDS 100mg/mL and monthly intravitreal ranibizumab 0.5mg treatment arms. They detected no new safety signals during follow-up.
The study authors concluded that the PDS resulted in fewer total ranibizumab treatments and was well-tolerated throughout the study period. “Vision and anatomic outcomes were comparable between the PDS 100mg/ml and monthly intravitreal injection arms,” they wrote in their paper.
Khanani AM, Callanan D, Dreyer R, 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. Ophthalmology. November 17, 2020. [Epub ahead of print].