Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial.

ABSTRACT:

Importance

Frequent prophylactic intravitreal anti-vascular endothelial growth factor injections can reduce risk of progression to vision-threatening complications in nonproliferative diabetic retinopathy (NPDR). A refillable drug delivery system for continuous intraocular ranibizumab release could offer less frequent treatment regimens.

Objective

To evaluate the Port Delivery System (PDS) with ranibizumab, 100 mg/mL, with refill-exchange procedures every 36 weeks (PDS Q36W), vs no PDS (control) in moderately severe to severe NPDR without center-involved diabetic macular edema (CI-DME), monitoring both groups every 4 weeks.

Design, setting, and participants

This was a randomized clinical trial at 50 US investigational sites. Participants aged 18 years or older with mo

SUBMITTER: Pieramici DJ 

PROVIDER: S-EPMC11886866 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature