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

NCT07581782 | Not Yet Recruiting

• 1 other identifier: IIT2026006
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration(nAMD)

Keywords

Faricimab; Neovascular Age-related Macular Degeneration(nAMD); Choroidal Vascularity Index (CVI)

Outcome Measures

Primary Outcomes (1)

• Choroidal Vascularity Index (CVI)

  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 Outcomes (2)

• visual contrast sensitivity

  Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks

• Height of pigment epithelial detachment

  Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks

Study Arms (1)

Neovascular Age-related Macular Degeneration(nAMD) Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Study Officials

• Chenjin Jin

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rongtian Chen

CONTACT

16619724130; 376126340@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ophthalmology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

CN (1)