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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 1 trial group
Group A: Neovascular Age-related Macular Degeneration(nAMD) Group

Trial outcomes

Primary outcomes

1

Choroidal Vascularity Index (CVI)

CVI represents the proportion of the total choroidal area occupied by blood vessels (luminal area).

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

Secondary outcomes

1

visual contrast sensitivity

Visual contrast sensitivity is the ability to detect differences in luminance (brightness) between an object and its background.

Time frame
Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks
2

Height of pigment epithelial detachment

The vertical distance between the detached retinal pigment epithelium (RPE) and the underlying Bruch's membrane.

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

Other outcomes

Sponsors and contacts

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