Faricimab for Age-Related Macular Degeneration

(CONSTANCE Trial)

Recruiting at 16 trial locations

Overseen By Reference Study ID Number: MR45638 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-VEGF, Complement inhibitors

Disqualifiers: Ocular histoplasmosis, Trauma, Myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 100 weeks

274 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for adults with a specific eye condition called neovascular age-related macular degeneration (nAMD) who haven't had previous treatments. They should be able to see at certain levels, have clear eyes for imaging, agree to follow contraception rules, and be generally healthy.

Inclusion Criteria

Agreement to adhere to the contraception requirements described in the protocol

I have untreated AMD-related vision loss with confirmed fluid in my retina.

Overtly healthy as determined by medical evaluation that includes medical history and physical examination

Exclusion Criteria

My vision loss is not due to age-related macular degeneration.

Current vitreous hemorrhage on Day 1

I have a tear in the retina affecting my central vision.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intravitreal 6-mg faricimab administered at up to 24-week intervals

100 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Faricimab

Trial Overview The study tests Faricimab's effectiveness and safety in treating nAMD over 100 weeks. Participants will receive the drug through an injection into the eye at intervals that could extend up to 24 weeks.

Participant Groups

Group I: Arm B: Faricimab Modified Treat & Extend Regimen Experimental Treatment 1 Intervention

Group II: Arm A: Faricimab Early Treat & Extend Regimen Experimental Treatment 1 Intervention

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