NCT03677934

A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration

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 Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Study GR40548 is a Phase III, randomized, multicenter, open-label (visual assessor \[VA\]-masked), active-comparator study designed to assess the efficacy, safety, and pharmacokinetics (PK) of 100mg/ml delivered via the Port Delivery System with ranibizumab (PDS) compared with ranibizumab intravitreal injections at 0.5 mg (10 mg/mL) in participants with neovascular age-related macular degeneration (nAMD).

Conditions

• Neovascular Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	PDS Implant filled with 100 mg/mL Ranibizumab	Will be administered as per the schedule described in individual arm.
DRUG	Intravitreal Injections of 10 mg/mL Ranibizumab	Will be administered as per the schedule described in individual arm.

Timeline

• Start date: 2018-09-12
• Primary completion: 2020-05-22
• Completion: 2021-06-09
• First posted: 2018-09-19
• Last updated: 2022-10-04
• Results posted: 2022-03-25

Locations

77 sites across 1 country: United States

Regulatory

• FDA-regulated drug study