Continuous Ranibizumab via Port Delivery System vs Monthly Ranibizumab for Treatment of Diabetic Macular Edema: The Pagoda Randomized Clinical Trial.

ABSTRACT:

Importance

Frequent visits and intravitreal anti-vascular endothelial growth factor (VEGF) injections are often required to manage diabetic macular edema (DME), burdening patients and their health care networks. The Port Delivery System (PDS) with ranibizumab is the first continuous anti-VEGF therapy that has the potential to reduce visit and treatment burden without sacrificing vision outcomes for patients with DME.

Objective

To evaluate the efficacy and safety through 64 weeks of ranibizumab, 100 mg/mL, via PDS with refill exchanges every 24 weeks (PDS Q24W) in patients with DME vs intravitreal injections of ranibizumab, 0.5 mg, every 4 weeks (monthly ranibizumab).

Design, setting, and participants

This randomized clinical trial was a phase 3, multicenter, noninferi

SUBMITTER: Khanani AM 

PROVIDER: S-EPMC11886869 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature