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Neovascular Age-related Macular Degeneration(nAMD)NCT07088445

Therapeutic Prospects of Faricimab Injection for Patients Affected by Neovascular Age-Related Macular Degeneration

An observational study of Neovascular Age-related Macular Degeneration(nAMD), run by Hui Peng.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Neovascular Age-Related Macular Degeneration (nAMD) is one of the main causes of irreversible vision loss in the elderly, characterized by neovascularization and vascular leakage in the macular area, ultimately leading to damage to retinal structure and visual impairment. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Faricimab
Type of treatment
Injection or infusion
How many people
35 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 30 Jun 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study enrolls patients aged 50-80 years with refractory neovascular age-related macular degeneration (nAMD), defined as persistent disease activity (central subfield thickness ≥300 μm + intra-/subretinal fluid) despite ≥6 anti-VEGF injections within 12 months or ≥4 injections within 6 months. Eligible participants must have a baseline BCVA of 24-73 ETDRS letters (Snellen ~20/40-20/320) and no confounding ocular comorbidities (e.g., diabetic retinopathy, macular fibrosis) or uncontrolled systemic conditions (e.g., hypertension, diabetes). Exclusions include recent ocular surgery (<3 months), drug hypersensitivity, or inability to comply with follow-up.

Who may be able to join

  • Diagnosis of wet age-related macular degeneration (nAMD) in individuals aged 50 years to 80 years.
  • Refractory nAMD: ≥ 6 injections of anti VEGF drugs within 12 months or ≥ 4 injections within 6 months, CFT ≥300 μm， In addition, there is retinal fluid.
  • BCVA is 24 to 73 letters (equivalent to Snellen vision of about 20/40 to 20/320) in the early treatment of diabetes retinopathy study (ETDRS) scoring scale.
  • The subjects can understand the purpose of the study and voluntarily sign a written informed consent.

Who cannot join

  • Accompanied by other eye diseases that may affect the structure or function of the macula (such as diabetes retinopathy, uveitis, etc.). There are obvious scars or fibrosis on the vitreous or retina.
  • There is uncontrolled hypertension, diabetes or other systemic diseases that may affect the treatment effect.
  • Having undergone eye surgery (such as retinal laser treatment or vitrectomy) and less than 3 months after surgery.
  • Allergic to farnesyl monoclonal antibody or its components.
  • Patients who are unable to complete follow-up or have poor compliance.
  • Researchers determine other factors that may affect the safety or data integrity of the experiment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

xuefeng qin contact

86+17772307246

846824618@qq.com

About this study

Neovascular Age-Related Macular Degeneration (nAMD) is one of the main causes of irreversible vision loss in the elderly, characterized by neovascularization and vascular leakage in the macular area, ultimately leading to damage to retinal structure and visual impairment. At present, anti vascular endothelial growth factor (VEGF) therapy is the main approach for treating nAMD, including VEGF inhibitors such as Aflibercept and Conbercept. However, some patients show decreased treatment tolerance or efficacy after long-term use of these drugs . Faricimab, a bispecific antibody that targets both VEGF and angiopoietin-2 (Ang-2), is expected to provide a new treatment option for patients resistant to existing VEGF therapies due to its unique dual mechanism of action The aim of this study is to explore the treatment response rate and prognosis of farnesyl monoclonal antibody in patients with refractory nAMD, including visual improvement and imaging changes, in order to provide more scientific treatment decision-making basis for clinical practice. At the same time, to determine its efficacy and safety in actual clinical treatment, in order to provide more flexible and personalized treatment options for nAMD patients, reduce their treatment burden, improve treatment compliance and quality of life.

Being tested
Faricimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Intravitreal injection of 6mg famotizumab into the vitreous cavity of patients with non primary wet age-related macular degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants With a Valid vs. Invalid Response at Month 6

    ① Valid response: a. Good response: No IRF, SRF, and ≥75% reduction in CMT; b. Partial response: Persistent IRF/SRF with a 25-75% reduction in CMT. ② Invalid response: a. Poor response: Persistent or new IRF/SRF with a 0-25% reduction in CMT; b. No response: IRF, SRF, and/or PED remain unchanged or increased.

    Measured: Month 6

Secondary outcomes (3)

  1. Change in Best-Corrected Visual Acuity (BCVA) From Baseline

    Change in BCVA as measured by ETDRS letter score.

    Measured: Baseline Month 3 Month 6

  2. Change in Central Macular Thickness (CMT) From Baseline

    Change in central macular thickness measured via OCT

    Measured: Baseline Month 3 Month 6

  3. Change in NEI VFQ-25 Score From Baseline

    Change in patient-reported visual function based on the NEI VFQ-25 (scale 0-100)

    Measured: Baseline Month 3 Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07088445
Sponsor's protocol ID
2025-155-04
Status last verified
Jul 2025
First submitted
26 Jun 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared due to concerns regarding patient privacy, the limited scope of data use consent obtained from participants, and institutional policies restricting public data disclosure. Additionally, the current study does not have the infrastructure in place to support secure data sharing and oversight.

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-related Macular Degeneration(nAMD), run by Hui Peng.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact xuefeng qin (86+17772307246, 846824618@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With a Valid vs. Invalid Response at Month 6 (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07088445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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