PDS implant maintained vision, anatomic outcomes through 22 months in wet AMD
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Patients with wet age-related macular degeneration who received a Port Delivery System with a 100 mg/mL dose of ranibizumab had similar vision and anatomic outcomes as patients who received monthly intravitreal injections of ranibizumab.
“The PDS has the potential to reduce intravitreal injection treatment burden and improve real-world clinical study outcomes in patients with neovascular macular degeneration,” David A. Eichenbaum, MD, said at the virtual American Society of Retina Specialists meeting.
The LADDER phase 2 trial included 220 patients randomly assigned to receive the Port Delivery System (PDS, Genentech) in one of three ranibizumab doses or monthly 0.5 mg intravitreal Lucentis (ranibizumab, Genentech) injections. Researchers evaluated the time to the first PDS refill, change in best corrected visual acuity and central foveal thickness from baseline, and safety.
The trial included 58, 62 and 59 patients in the PDS 10 mg/mL, 40 mg/mL and 100 mg/mL arms, respectively, and 41 patients in the monthly intravitreal ranibizumab 0.5 mg arm. The median time to first refill in the 100 mg/mL PDS cohort was 8.8 months, as well as 8.8 months from the first to second refill, Eichenbaum said.
Patients in the PDS 100 mg/mL arm experienced a gain of 2.9 letters from baseline to month 22 compared with a 2.7 letter gain for monthly ranibizumab. Changes in central foveal thickness were also comparable between the two cohorts, he said.
The PDS implant surgery and refill procedure were generally well tolerated. No new safety signals were observed in the additional follow-up period, he said.
“The results of the phase 2 LADDER study supported the designs of the Archway phase 3 trial, which is ongoing and recently met its primary endpoint showing equivalent vision outcomes between the PDS 100 mg/mL every 24 weeks and monthly intravitreal ranibizumab 0.5 mg arms,” Eichenbaum said.
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Eichenbaum DA, et al. Ladder phase 2 trials of the Port Delivery System with ranibizumab (PDS) end of study results. Presented at: American Society of Retina Specialists annual meeting; July 24-26, 2020 (virtual meeting).
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