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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Choroidal Vascularity Index (CVI) [Срок оценки: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks]

Вторичные конечные точки (2)

• visual contrast sensitivity [Срок оценки: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks]
• Height of pigment epithelial detachment [Срок оценки: Baseline, 4 weeks,8 weeks,12 weeks,16 weeks,24 weeks,48 weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Zhongshan Ophthalmic Center, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT07581782 · IIT2026006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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