ISRCTN69073386进行中（未招募）3 期
A Phase IIIb/IV, multicenter, open-label, single-arm study to investigate the efficacy and safety of faricimab (RO6867461) in patients with polypoidal choroidal vasculopathy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •General inclusion criteria:
- •1. Age =50 years at the time of signing the informed consent form
- •Ocular inclusion criteria for study eye:
- •1. Have sufficiently clear ocular media and adequate pupillary dilatation to allow the acquisition of good-quality retinal images to confirm diagnosis
- •2. Confirmed diagnosis, by the investigator, of symptomatic macular PCV defined by the following:
- •2.1. Active macular polypoidal lesions shown by indocyanine green angiography (ICGA)
- •2.2. Presence of exudative or hemorrhagic features involving the macula as identified by the investigator using multimodal images
- •3. BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 m on study Day 1
排除标准
- •General exclusion criteria:
- •1. Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1
- •2. Any major illness or major surgical procedure within 1 month before screening
- •3. Active cancer within the 12 months prior to study Day 1
- •4. Uncontrolled blood pressure, defined as systolic blood pressure >180 mmHg and/or diastolic blood pressure > 100 mmHg while the participant is at rest on study Day 1
- •5. Participants with a history of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1
- •6. Participants with history of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
- •7. Participants with history of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
- •8. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab
- •Ocular exclusion criteria for both eyes:
- •1. Participants with history of idiopathic or autoimmune-associated uveitis in either eye
- •2. Participants with active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1
- •Ocular exclusion criteria for study eye:
- •1. Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, intraretinal fluid (IRF), or subretinal fluid (SRF)
- •2. Retinal pigment epithelial tear involving the macula on study Day 1
- •3. On fundus fluorescein angiography (FFA)/color fundus photograph (CFP):
- •3.1. Subretinal hemorrhage of > 4 macular photocoagulation study disc area and/or that involves the fovea
- •3.2. Fibrosis or atrophy of > 50% of the total lesion area and/or that involves the fovea
- •4. Any concurrent intraocular condition
- •5. Current vitreous hemorrhage on study Day 1
- •6. Uncontrolled glaucoma
- •7. Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-vascular endothelial growth factor (VEGF), steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention.
- •8. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy)
- •9. Prior periocular ph
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