NCT04567303

Study of Zifibancimig in Participants With Neovascular Age-related Macular Degeneration

A Three-part, Phase I/II Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Zifibancimig Following Intravitreal Administration of Multiple Ascending Doses and Continuous Delivery From the Port Delivery in Patients With Neovascular Age-related Macular Degeneration

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the port delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD).

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
DRUG	Zifibancimig	Part 1: multiple ascending doses by IVT injection. Each participant will receive zifibancimig at a constant volume of 50 microliter (µL) in the study eye. Part 2: participants will be randomized to one of two dose levels of zifibancimig in the PD implant. Part 3: Participants will receive one of the two dose levels of zifibancimig in the PD implant.
DRUG	Ranibizumab	Participants will receive ranibizumab 100 mg/mL through the PD implant
DEVICE	Port Delivery Platform	Participants will receive intraocular refillable device that is surgically inserted into the eye for continuous delivery of drugs into the vitreous.

Timeline

• Start date: 2020-10-28
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2020-09-28
• Last updated: 2026-02-04

Locations

48 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study
• FDA-regulated device study