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  • Ranibizumab Port Delivery System for AMD: Phase 2

    By Lynda Seminara
    Selected By: Stephen D. McLeod, MD
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    Journal Highlights

    Ophthalmology, August 2019

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    Campochiaro et al. investigated the safety and efficacy of the port delivery system with ranibizumab (PDS) for neovascular age-related macular degen­eration (AMD). They found a dose re­sponse for multiple end points, and the treatment generally was well tolerated. Visual and anatomic outcomes with PDS 100 mg/mL were comparable to those achieved by monthly intravitreal injection of ranibizumab 0.5 mg.

    This study, known as Ladder, was a phase 2 trial conducted among 220 patients with AMD diagnosed in the preceding nine months. Prior to study entry, all participants had received at least two intravitreal anti-VEGF injections and had responded to treat­ment. Patients were assigned randomly (3:3:3:2) to receive PDS filled with ranibizumab 10 mg/mL (n = 58), 40 mg/mL (n = 62), or 100 mg/mL (n = 59), or monthly intravitreal injection of ranibizumab 0.5 mg (n = 41). The primary efficacy end point was the time to initial refill of the implant; this was assessed when the last enrollee completed the month 9 visit. Other outcomes included safety, improvement in best-corrected visual acuity (BCVA), and change in central foveal thickness. BCVA was assessed using the letter chart of the Early Treatment Diabetic Retinopathy Study (ETDRS).

    The median time to first refill was 8.7, 13.0, and 15.0 months for recip­ients of PDS 10, 40, and 100 mg/mL, respectively. At month 9, the adjusted mean changes from baseline in BCVA were -3.2, -0.5, +5.0, and +3.9 ETDRS letters for treatment with PDS 10 mg/mL, PDS 40 mg/mL, PDS 100 mg/mL, and monthly injections, respec­tively. At month 9, the adjusted mean change from baseline in central foveal thickness was similar for those in the PDS 100 mg/mL group and the monthly injection group, but the implant system involved fewer treat­ment sessions.

    In general, PDS insertions and refills were well tolerated. After optimizing the surgical procedure, the rate of postoperative vitreous hemorrhage was 4.5% (7 of 157); only one event was classified as serious. There was no sign of implant clogging.

    The researchers concluded that this system may reduce treatment burden while preserving vision. The findings indicate that VEGF inhibition can be sustained safely for lengthy periods using the PDS, with outcomes similar to those of monthly injections. This may help guide treatment for AMD and other retinal conditions. The Archway phase 3 trial is the next step.

    The original article can be found here.