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

6. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

50

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Neovascular Age-related Macular Degeneration(nAMD) Group

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Choroidal Vascularity Index (CVI)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
visual contrast sensitivity
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

31. mai 2028

Studiet fullført (Antatt)

31. mai 2028

Datoer for studieregistrering

Først innsendt

6. mai 2026

Først innsendt som oppfylte QC-kriteriene

6. mai 2026

Først lagt ut (Faktiske)

12. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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