Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients

NCT ID: NCT06572553

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-08-31

Brief Summary

The goal of this clinical trial is to learn if drug Faricimab works to treat nAMD, DME or RVO in adults. It will also learn about the safety of drug Faricimab. The main questions it aims to answer are:

Does drug Faricimab can improve the best-corrected visual acuity of participants? What medical problems do participants have when inject drug Faricimab? Participants will inject drug Faricimab every month for 3 months. Visit the clinic once every 2 weeks for checkups.

Detailed Description

Intravitreal anti-vascular endothelial growth factor (VEGF) therapies are used to treat retinal vascular diseases such as neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). However, the clinical effectiveness of such therapies is often suboptimal, often resulting in poor treatment adherence due to the burden of frequent monitoring and injection therapy (every 4-8 weeks). Different approaches have been investigated to improve outcomes in such diseases, including modification of dosing regimens to reduce treatment burden and continued research to identify new drug targets. Angiopoietin-2 (Ang-2) has been implicated in the pathogenesis of several retinal vascular diseases, including nAMD and DME, and has therefore been identified as a potential new target.

Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech. Dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease. Faricimab is administered via intravitreal injection. It is the first bispecific antibody designed for intraocular use. In January 2022, faricimab was approved in the United States for the treatment of participants with nAMD or DME. And in March 2024, faricimab began to be approved for use in the treatment of patients in our clinic.

Therefore, investigators collected participants who were injected with Faricimab in the clinic and conducted follow-up visits to evaluate the therapeutic efficacy and application prospect of Faricimab in the clinic.

Conditions

Age-Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injection of faricimab

Intervention: Intravitreal Injections Generic name: faricimab Dosage: 0.05ml (6mg) Frequency: every month Duration: 3 months

Group Type: EXPERIMENTAL

Faricimab

Intervention Type: DRUG

Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech, and dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease relative to anti-VEGF therapy alone.

Interventions

Faricimab

Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech, and dual-pathway inhibition may provide stronger and longer-lasting efficacy in the treatment of retinal vascular disease relative to anti-VEGF therapy alone.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Chinese patients aged 18 years or older and of any gender;

2. Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;

3. Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;

4. Patients who have received at least one treatment with faricimab during the course of the study;

5. have signed an informed consent form.

Exclusion Criteria

1. Active ocular inflammation or suspected active ocular infection in either eye;

2. Receipt of any other anti-VEGF therapy after faricimab;

3. Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;

4. Currently participating in any other clinical trial.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Panpan Ye, doctor

Role: STUDY_DIRECTOR

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hanzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Panpan Ye, doctor

Role: CONTACT

yepanpan@zju.edu.cn

+86 13806506267

Ningxi Hong, master

Role: CONTACT

22218651@zju.edu.cn

+86 19550173720

Facility Contacts

Panpan Ye, doctor

Role: primary

yepanpan@zju.edu.cn

+86 13806506267

Ningxi Hong, master

Role: backup

2218651@zju.edu.cn

+86 19550173720

References

Ferro Desideri L, Traverso CE, Nicolo M, Munk MR. Faricimab for the Treatment of Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration. Pharmaceutics. 2023 May 5;15(5):1413. doi: 10.3390/pharmaceutics15051413.

Reference Type: BACKGROUND

PMID: 37242655 (View on PubMed)

Stanga PE, Valentin-Bravo FJ, Stanga SEF, Reinstein UI, Pastor-Idoate S, Downes SM. Faricimab in neovascular AMD: first report of real-world outcomes in an independent retina clinic. Eye (Lond). 2023 Oct;37(15):3282-3289. doi: 10.1038/s41433-023-02505-z. Epub 2023 Mar 23.

Reference Type: BACKGROUND

PMID: 36959312 (View on PubMed)

Giancipoli E, Guglielmi A, Bux AV, Clima GME, Pignatelli F, Boscia F, Viggiano P, Boscia G, Fortunato F, Besozzi G, Niro A, Dore S, Iaculli C. Real-World Outcomes of a Loading Phase with Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration (n-AMD) and Diabetic Macular Edema (DME). Ophthalmol Ther. 2024 Aug;13(8):2163-2184. doi: 10.1007/s40123-024-00980-5. Epub 2024 Jun 4.

Reference Type: BACKGROUND

PMID: 38831127 (View on PubMed)

Other Identifiers

2024-0612

Identifier Type: -

Identifier Source: org_study_id