Prospective, Single Arm, Observational Study of Faricimab in the Treatment of Neovascular Age-related Macular Degeneration (nAMD)

May 6, 2026 updated by: Jin Chen-jin, Sun Yat-sen University
Evaluate the benefit of faricimab (4 loading doses + PRN) on best-corrected visual acuity in patients with nAMD. Evaluate the safety and anatomical improvement of faricimab (4 loading doses + PRN) in patients with nAMD.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This study is a prospective, single-arm, observational study designed to evaluate the efficacy and safety of faricimab (4 loading doses + PRN) in patients with neovascular age-related macular degeneration (nAMD). Patients first receive four intravitreal loading injections of faricimab (6 mg each) at 4-week intervals, followed by a pro re nata (PRN) treatment phase. The study assesses changes from baseline in best-corrected visual acuity (BCVA), contrast sensitivity, choroidal vascularity index (CVI), maximum pigment epithelial detachment (PED) height, and the proportion of patients with intraretinal fluid (IRF) / subretinal fluid (SRF) at weeks 4, 8, 12, 16, 24, and 48. The objective is to evaluate the visual benefit, anatomical improvement, and safety of faricimab (4 loading doses + PRN) in treating nAMD. The use of other anti-VEGF agents (systemic or ocular) is prohibited during the treatment period.

Study Type

Observational

Enrollment (Estimated)

50

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 Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

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

Sampling Method

Non-Probability Sample

Study Population

The study subjects were recruited from outpatients of the Medical Retina Department at Zhongshan Ophthalmic Center, and eligible cases meeting the study criteria were selected from the outpatient medical record system.

Description

Inclusion Criteria:

  • Age ≥50 years, any gender.
  • The study eye must have active treatment-naïve macular neovascularization (MNV) secondary to AMD, confirmed by the investigator based on OCT images showing the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) involving the fovea.
  • The study eye must have a best-corrected visual acuity (BCVA) measured using the 4-meter ETDRS chart of 24-78 ETDRS letters (approximately Snellen equivalent 20/320 - 20/32).
  • Central subfield thickness (CST) ≥300 μm.
  • The study eye has sufficiently clear ocular media and adequate pupillary dilation.
  • Women of childbearing potential must use contraceptive measures during the study treatment period and for at least 3 months after the last dose.
  • The patient and their legal representative are able to understand and sign the informed consent form, and are willing to comply with the follow-up and treatment plan specified in the study protocol.
  • Patients with nAMD who have already been determined to receive the faricimab (4 loading doses + PRN) treatment regimen based on clinical need, for post-treatment observation.
  • Only one eye will be selected as the study eye (if both eyes meet the criteria, the investigator will select the eye with worse visual acuity as the study eye).

Exclusion Criteria:

  • Patients with ocular or periocular infection.
  • Patients with active intraocular inflammation.
  • Known hypersensitivity to faricimab or any of its excipients.
  • Previous treatment with any other investigational therapy or any therapy that affects choroidal neovascularization (CNV) or macular neovascularization (MNV), or any therapy used for AMD.
  • Presence of any ocular or systemic disease other than nAMD that may affect visual acuity assessment.
  • Prior treatment in the study eye with anti-VEGF agents, corticosteroids, or laser therapy.
  • Structural damage to the fovea in the study eye that is likely to prevent BCVA improvement even after resolution of macular edema (e.g., retinal pigment epithelial atrophy, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates).
  • Presence of retinal pigment epithelial tear involving the macula in the study eye at screening.
  • Uncontrolled glaucoma in the study eye.
  • Refractive error in the study eye with spherical equivalent exceeding 6 diopters of myopia.
  • Any cataract surgery or steroid treatment for cataract surgery complications in the study eye within 6 months prior to screening.
  • Pregnant or breastfeeding women.
  • Patients considered unsuitable for study enrollment by the investigator for other reasons.
  • Inability to provide baseline clinical data (BCVA, visual contrast sensitivity, indocyanine green angiography (ICGA) images, optical coherence tomography angiography (OCTA) images, OCT images, color fundus photography (CFP) images) within 2 weeks (14 days) prior to the first faricimab treatment.

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

Cohorts and Interventions

Group / Cohort
Neovascular Age-related Macular Degeneration(nAMD) Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choroidal Vascularity Index (CVI)
Time Frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
CVI represents the proportion of the total choroidal area occupied by blood vessels (luminal area).
Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual contrast sensitivity
Time Frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Visual contrast sensitivity is the ability to detect differences in luminance (brightness) between an object and its background.
Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
Height of pigment epithelial detachment
Time Frame: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
The vertical distance between the detached retinal pigment epithelium (RPE) and the underlying Bruch's membrane.
Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Chenjin Jin, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, Guangdong 510060

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

May 31, 2028

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIT2026006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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