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

Phase 2

Recruiting

• Conditions: Age-Related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion
• Interventions: Drug: Faricimab

• Registration Number: NCT06572553
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-01
• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-25
• Last Update Submitted: 2024-08-25
• Study First Posted: 2024-08-27
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA)	through study completion, an average of 3 months.	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.

Secondary Outcome Measures

Name	Time	Method
central retinal thickness (CRT)	through study completion, an average of 3 months.	Retinal thickness will be measured by using optical coherence tomography (OCT). Patients will undergo standardised retinal imaging, performed after pupil dilation. The average retinal thickness in and around the central sulcus will be measured using an automatically generated thickness map from the OCT device.
Choroidal neovascularization (CNV)	through study completion, an average of 3 months.	Choroidal neovascularisation was measured by OCT and OCTA. Standardised retinal imaging was performed after pupil dilation. Using the images provided by the OCT and OCTA devices, the presence or absence of accompanying choroidal neovascularisation was measured, and if present, the type was further determined

Trial Locations

Locations (1)

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China; 🇨🇳 Hanzhou, Zhejiang, China