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

Zhejiang University

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Age-Related Macular Degeneration

Diabetic Macular Edema

Retinal Vein Occlusion

Treatments

Drug: Faricimab

Study type

Interventional

Funder types

Other

Identifiers

NCT06572553

2024-0612

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.