Faricimab for Age-Related Macular Degeneration
(CONSTANCE Trial)
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.12345Why 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.678910
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravitreal 6-mg faricimab administered at up to 24-week intervals
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
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
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 ...
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.
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.
Efficacy of Every Four Monthly and Quarterly Dosing ...
Faricimab maintains initial vision and anatomic improvements comparable with ranibizumab in neovascular age-related macular degeneration.
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 ...
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 ...
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 ...
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).
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), ...
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 ...
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