NCT04108156

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME

A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 634 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	PDS Implant Pre-Filled with 100 mg/mL Ranibizumab	Will be administered as per the schedule described in individual arm.
DRUG	Intravitreal Ranibizumab 0.5 mg Injection	Will be administered as per the schedule described in individual arm.
DRUG	Ranibizumab refill exchange	Will be administered as per the schedule described in individual arm.

Timeline

• Start date: 2019-09-30
• Primary completion: 2027-11-16
• Completion: 2027-11-16
• First posted: 2019-09-30
• Last updated: 2026-03-06

Locations

92 sites across 1 country: United States

Regulatory

• FDA-regulated drug study