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

August 25, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310000
        • Recruiting
        • 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection of faricimab
Intervention: Intravitreal Injections Generic name: faricimab Dosage: 0.05ml (6mg) Frequency: every month Duration: 3 months
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: 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.
through study completion, an average of 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
central retinal thickness (CRT)
Time Frame: 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.
through study completion, an average of 3 months.
Choroidal neovascularization (CNV)
Time Frame: 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
through study completion, an average of 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Panpan Ye, doctor, 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0612

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Basic characteristics,multimodal imaging data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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