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

NCT06572553 | Recruiting Phase 2

• 1 other identifier: 2024-0612
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity (BCVA)

  BCVA will be measured at a standard distance of 4 metres under standardised lighting conditions (85-100 candela) by using an ETDRS optometer. Each eye will be tested separately with the participants who wear best corrected vision glasses. The smallest line of letters that the patient can correctly identify will be recorded as their BCVA.Measurements will be taken by trained ophthalmologists at baseline and at time points such as 2 weeks after the start of the trial and 1 month after the start of the trial to ensure consistency.

  through study completion, an average of 3 months.

Secondary Outcomes (2)

• central retinal thickness (CRT)

  through study completion, an average of 3 months.

• Choroidal neovascularization (CNV)

  through study completion, an average of 3 months.

Study Arms (1)

Injection of faricimab

EXPERIMENTAL

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

Drug: Faricimab

Interventions

Faricimab 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.

Injection of faricimab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese patients aged 18 years or older and of any gender;
• Patients who have been diagnosed with nAMD, DME or RVO by OCT, FFA, ICGA or OCTA;
• Patients whose decision to receive treatment with faricimab was made prior to and independent of study participation;
• Patients who have received at least one treatment with faricimab during the course of the study;
• have signed an informed consent form.

You may not qualify if:

• Active ocular inflammation or suspected active ocular infection in either eye;
• Receipt of any other anti-VEGF therapy after faricimab;
• Patient is unable to provide clinical data (visual acuity and OCT images) within 2 weeks (14 days) prior to receiving the initial faricimab injection;
• Currently participating in any other clinical trial.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 37242655 BACKGROUND

• 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.

  PMID: 36959312 BACKGROUND

• 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.

  PMID: 38831127 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion

Interventions

faricimab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Panpan Ye, doctor

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

  STUDY DIRECTOR

Central Study Contacts

Panpan Ye, doctor

CONTACT

+86 13806506267; yepanpan@zju.edu.cn

Ningxi Hong, master

CONTACT

+86 19550173720; 22218651@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: All roles know what drug they injected.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Chinese patients aged 18 years or older ; 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.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 27, 2024
• Study Start: March 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)