Genentech Completes Patient Enrollment In Phase 2 Study Evaluating A New Delivery System for Lucentis
Genentech has completed enrollment in the LADDER (Long Acting Delivery of Ranibizumab) trial, a phase 2, multicenter, randomized, active treatment-controlled clinical trial investigating the efficacy and safety of the ranibizumab port delivery system (RPDS) for the sustained delivery of Lucentis (ranibizumab) in people with wet age-related macular degeneration (AMD) who have previously responded to treatment with anti-vascular endothelial growth factor (VEGF) therapies. The RPDS program will help determine whether the RPDS implant can reduce the treatment burden for people with wet AMD, including fewer office visits and re-treatments, while achieving vision gains comparable to patients treated with monthly injections.
“We are excited to announce we have completed enrollment in the LADDER study for the RPDS, as we believe it could potentially be a useful new treatment platform for both wet AMD patients and ophthalmologists,” said Giulio Barteselli, MD, Associate Medical Director, Genentech Ophthalmology.
The RPDS implant is filled with ranibizumab and is inserted into the eye with a surgical procedure that typically takes place in about 30 minutes. The RPDS implant is designed to release ranibizumab over a period of months and is refillable, when needed, with a minimally invasive office-based procedure. In the LADDER trial, patients are randomized to receive the RPDS implant with one of three different ranibizumab formulations, or intravitreal ranibizumab 0.5 mg administered monthly. The primary endpoint is the time until a patient first requires the RPDS implant to be refilled according to protocol-defined refill criteria.
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