Faricimab for Age-Related Macular Degeneration

(CONSTANCE Trial)

Not currently recruiting at 86 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests faricimab, a treatment for age-related macular degeneration (AMD), a condition that can cause vision loss. The study will evaluate the medication's effectiveness, safety, and duration of effects. Participants will follow either an early or modified treatment plan. Suitable candidates have not received treatment for AMD in their affected eye and experience noticeable vision issues due to this condition. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that faricimab is generally safe for individuals with neovascular age-related macular degeneration (nAMD). Most patients in studies did not experience serious side effects. Commonly reported issues are mild, such as redness or irritation in the eye.

Faricimab has already received approval for treating nAMD and diabetic macular edema, a condition involving swelling in the retina due to diabetes. This approval indicates its safety for these conditions. Real-world data further support its safety, with no new safety concerns identified post-approval.

Overall, faricimab seems to be a safe option for those considering participation in a clinical trial for nAMD treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Faricimab for age-related macular degeneration (AMD) because it offers a novel approach compared to existing treatments like anti-VEGF injections such as ranibizumab and aflibercept. Faricimab is unique because it targets two pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—which could potentially improve the control of retinal swelling and vision outcomes. Additionally, the trial explores two different dosing regimens: an early treat-and-extend and a modified treat-and-extend regimen, which might offer more flexibility and less frequent dosing compared to current treatments, potentially improving patient convenience and adherence.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

This trial will compare two different regimens of faricimab for treating neovascular age-related macular degeneration (nAMD). Studies have shown that faricimab works well for this condition, which affects vision. In one study, patients who used faricimab maintained their vision improvements compared to those using ranibizumab. Another study found that faricimab also benefited patients who did not respond well to other treatments. Overall, this research suggests that faricimab can be a strong option for managing nAMD, helping to maintain vision and improve eye health over time. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. nature.com nature.com/articles/s41598-025-18376-1

Real world outcomes of faricimab in treatment resistant ... We included all patients aged 50 years and older with a clinical diagnosis of exudative age-related macular degeneration (AMD) or polypoidal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12364751/

One-year outcomes of faricimab for neovascular age related ... One-year outcomes of faricimab for neovascular age related macular degeneration with OCT angiography: focus on resistant and refractory cases.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525000429

Real-World Evidence for Faricimab in Neovascular Age ... Bezlyak, et al. SIERRA-AMD: a retrospective, real-world evidence study of patients with neovascular age-related macular degeneration in the United States.

4. jamanetwork.com jamanetwork.com/journals/jamaophthalmology/fullarticle/2768857

Efficacy of Every Four Monthly and Quarterly Dosing ... Faricimab maintains initial vision and anatomic improvements comparable with ranibizumab in neovascular age-related macular degeneration.

5. journals.healio.com journals.healio.com/doi/10.3928/23258160-20250304-02

Early Outcomes After Initiation of Faricimab for Neovascular ... Early Outcomes After Initiation of Faricimab for Neovascular Age-Related Macular Degeneration ... AMD is a retrospective cohort study using data ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268043/

Efficacy and safety of faricimab for neovascular age-related ... Age-related macular degeneration (AMD) stands as a prominent contributor to severe visual impairment and blindness, accounting for 8.7% of ...

7. nature.com nature.com/articles/s41598-024-62559-1

One-year outcomes and safety assessment of faricimab in ... One-year outcomes and safety assessment of faricimab in treatment-naïve patients with neovascular age-related macular degeneration in Japan. Ryo ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04777201?term=NCT04777201&rank=1

NCT04777201 | A Study to Evaluate the Long-Term Safety ... A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X).

9. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145%2825%2900042-9/fulltext

Real-World Evidence for Faricimab in Neovascular Age ... Since faricimab (Vabysmo) was approved for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME), ...

10. roche.com roche.com/media/releases/med-cor-2025-09-05

New data for Roche's Vabysmo reinforce its efficacy, safety ... Age-related macular degeneration (AMD) is a condition that affects ... Efficacy, durability, and safety of intravitreal faricimab up to ...