Who is sponsoring Archway?

Archway is sponsored by Hoffmann-La Roche.

What condition does Archway study?

Archway studies Neovascular Age-Related Macular Degeneration.

What drugs are being tested in Archway?

Interventions: PDS Implant filled with 100 mg/mL Ranibizumab, Intravitreal Injections of 10 mg/mL Ranibizumab.

What is the status of Archway?

Archway is currently COMPLETED.

Last reviewed 2022-10-04 · How we verify

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 (Archway)

NCT03677934 PHASE3 COMPLETED Results posted

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).

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	COMPLETED
Enrolment	415
Start date	Wed Sep 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jun 09 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

PDS Implant filled with 100 mg/mL Ranibizumab
Intravitreal Injections of 10 mg/mL Ranibizumab

Countries

United States