Faricimab for Age-Related Macular Degeneration

(AVONELLE-X Trial)

Recruiting at291 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing the long-term safety of injecting faricimab into the eyes of patients with a specific eye condition called nAMD. These patients have already participated in earlier studies. The drug works by stopping abnormal blood vessel growth in the eye to help prevent vision loss. Faricimab has shown positive results in multiple studies for treating eye diseases.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with neovascular age-related macular degeneration who completed previous Phase III studies (GR40306 or GR40844) without dropping out. Women must use effective contraception and not donate eggs during the study. People can't join if they're pregnant, breastfeeding, plan to become pregnant soon, have other eye diseases or conditions that make faricimab unsafe for them, or are allergic to its components.

Inclusion Criteria

Previous enrollment in and completion of Study GR40306 (NCT03823287) or Study GR40844 (NCT03823300), without study or study drug discontinuation

For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 3 months after the final dose of faricimab. Women must refrain from donating eggs during the same period.

Exclusion Criteria

You have had a serious allergic reaction in the past to a biologic medication or any of the substances used in the study injections or preparations.

I am not on any medications that are not allowed in the study.

I don't have any health conditions that would make using faricimab unsafe for me.

Treatment Details

Interventions

• Faricimab (Monoclonal Antibodies)
• Sham Procedure (Procedure)

Trial Overview The trial tests the long-term safety of Faricimab given by injection into the eye at personalized intervals to treat nAMD. A substudy also compares treated eyes with untreated fellow eyes to assess corneal health as required by the FDA.

Participant Groups

Group I: Substudy: Faricimab PTI Experimental Treatment 1 Intervention

Group II: Main Study: Faricimab PTI Experimental Treatment 2 Interventions

Faricimab is already approved in Canada for the following indications:

Approved in Canada as Vabysmo for:

• Neovascular age-related macular degeneration (nAMD)
• Diabetic macular edema (DME)

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University