Título / Title

THE ARCHWAY PHASE 3 TRIAL OF THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB (PDS) FOR NAMD: DATA UPDATE AND KEY SURGICAL PEARLS

Introdução / Purpose

PDS with ranibizumab (RBZ) is an investigational drug delivery system for continuous i.v. RBZ release through a surgically implanted, refillable ocular implant. Here are results from Archway Sep 2020 data cut and report key optimization of the PDS implant

Material e Método / Methods

Pts randomized 3:2 to treat. with the PDS with RBZ 100 mg/mL with fixed PDS Q24W or i.v. RBZ 0.5 mg injections Q4W. Pts have nAMD within 9 months of screening and responsive to anti−VEGF treat., with ≥ 3 i.v. anti-VEGF injections within 6 months. The trial evaluated noninferiority (NI) and equivalence of the PDS Q24W vs monthly RBZ of BCVA change from baseline averaged over W36/40. Sep 2020 data cut extended results through ≥ 48W of follow-up. Implant insertion procedure has 7 major steps: peritomy, implant preparation, scleral dissection, pars plana laser ablation, pars plana incision, implant insertion, and conjunctival and Tenon’s capsule closure

Resultados / Results

Change in adjusted mean BCVA score from baseline averaged over W44/48 was 0.0 (PDS Q24W) vs +0.2 (monthly RBZ). PDS Q24W was noninferior to monthly RBZ at W44/48, with a difference (95% CI) of –0.2 (–1.8, +1.3) letters. 98.4% and 94.6% of PDS Q24W pts did not receive supplemental RBZ during the 1st or 2nd refill-exchange interval. The mean total treat. number was 3.9 (PDS Q24W) versus 19.5 (monthly RBZ). PDS procedures were well tolerated and the ocular safety profile was unchanged from the primary analysis. Systemic safety findings were comparable across arms. Edge-to-edge pars plana laser ablation while maintaining a final incision size of 3.5 mm ensures a secure implant fit and p.o. hemostasis

Discussão e Conclusões / Conclusion

Attention to laser application, hemostasis control, and proper handling of the conjunctiva and Tenon’s capsule during the PDS implant insertion procedure is important to minimize complications. To maximize optimal surgical outcomes, the procedure requires careful attention to elements generally not emphasized in other vitreoretinal procedures

Palavras Chave

Port Delivery System
Ranibizumab
Wet Macular Degeneration
Retinal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

Area

CLINICAL RETINA