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.
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
- Conditions the study is for
- Neovascular Age-related Macular Degeneration(nAMD)
- 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
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.
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.
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)
Change in Best-Corrected Visual Acuity (BCVA) From Baseline
Change in BCVA as measured by ETDRS letter score.
Measured: Baseline Month 3 Month 6
Change in Central Macular Thickness (CMT) From Baseline
Change in central macular thickness measured via OCT
Measured: Baseline Month 3 Month 6
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.
- First posted28 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular Degeneration(nAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Hui Peng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hui Peng, First Affiliated Hospital of Chongqing Medical University
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.