2025-522701-38-00招募中4 期
EFFICACY OF FARICIMAB IN PATIENTS WITH SUBRETINAL HYPERREFLECTIVE MATERIAL ASSOCIATED WITH TYPE 2 OR MIXED NEOVASCULAR MEMBRANES ASSESSED BY MULTIMODAL IMAGING
Asociacion Instituto De Investigacion Sanitaria Biobizkaia10 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年12月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Resolution of SHRM at week 16
研究概览
简要总结
To determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •People aged 50 and over
- •Diagnosed with bilateral or unilateral AMD
- •Eyes with SHRM and type 2 or mixed (type 1 and 2) neovascular membrane
- •Näive eyes treated with Faricimab following SmPC (summary of product characteristic)
- •They agree to participate in the study and sign the informed consent form
排除标准
- •Eyes with type 1, aneurysmal type 1 and type 3 MNV
- •Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum)
- •Eyes with ocular media opacity
- •Patients with other retinal diseases that could compromise the best corrected visual acuity and interfere in the values of retinal parameters
- •Any ocular or neurological condition (including cognitive impairment) that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with the assessment, procedures, or completion of the study
- •People who are participating or will participate in any type of clinical trial
- •Pregnant women
- •Breastfeeding women
- •Men and Women* of childbearing potential who are unable or unwilling to use highly effective methods of contraception (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) from the start to the end of the study
结局指标
主要结局
Resolution of SHRM at week 16
Resolution of SHRM at week 16
次要结局
未报告次要终点
研究者
uiceecc regulatoria
Scientific
Asociacion Instituto De Investigacion Sanitaria Biobizkaia
研究点 (10)
Loading locations...
相似试验
尚未招募
不适用
Analysis of The Outcomes of Therapeutic Photorefractive Keratectomy Combined With Prophylactic Accelerated Cross-Linking (PRK-Plus), for Treatment of Thin Suspicious CorneaNCT07277348Fayoum University60
招募中
4 期
Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)2024-515497-26-00Medical University Of Graz33
招募中
2 期
Phase I/II Follow-up Study of SAR422459 in Patients with Stargardt’s Macular Degeneration2024-513501-31-00Sanofi-Aventis Recherche & Developpement14
进行中（未招募）
3 期
SMR001 滴眼液在中至重度干眼患者中的有效性和安全性的 III 期临床研究CTR20254690800
已完成
3 期
FARICIMAB 治疗视网膜中央静脉阻塞或半侧视网膜静脉阻塞继发黄斑水肿患者的临床试验CTR2021014982