A Randomized, Double-masked, Sham-controlled Phase 4 Study of the Efficacy, Safety, and Tolerability of IV Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy in Patients With PCV.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 13
- 主要终点
- Change in Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept plus standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV).
详细描述
To compare the efficacy and safety of intravitreal Aflibercept monotherapy with the efficacy and safety of combined treatment with Aflibercept associated with standard photodynamic therapy (PDT) with Verteporfin in age-related macular degeneration (AMD) patients with polypoidal choroidal vasculopathy (PCV) in a proof concept study and to identify genetic biomarkers for the diagnosis and treatment response of PCV in Caucasians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either gender and Age ≥
- •Naïve PCV patients.
- •Confirmed diagnosis of symptomatic macular PCV in the study eye.
- •Greatest linear dimension of the lesion of < 5400 mm, assessed by ICG angiography.
- •BCVA at study entry of 25 to 80 letters (Snellen Equivalent 20/320 to 20/25).
- •Lesion size in the study eye at study entry:
- •Presence of PCV assessed by the Central Reading Centre based on ICG with active polyps with or without abnormal vascular network.
- •Women must be using effective contraception, be post-menopausal for at least
- •months prior to trial entry, or surgically sterile.
- •Ability to provide written informed consent.
- •Ability to return for all study visits.
排除标准
- •Active inflammation or infection in the study eye.
- •Uncontrolled intraocular pressure in the study eye.
- •Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epirretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
- •Presence of centromacular scarring or atrophy indicating irreversible BCVA loss.
- •Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
- •Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
研究组 & 干预措施
Aflibercept Monotherapy
IVT Aflibercept 2 mg + Sham PDT
干预措施: Intravitreal Aflibercept (Drug)
Aflibercept + verteporfin PDT
IVT Aflibercept 2 mg + Verteporfin PDT
干预措施: Intravitreal Aflibercept (Drug)
结局指标
主要结局
Change in Best Corrected Visual Acuity (BCVA)
时间窗: from Baseline (Week 0) to Week 52.
Unit of Measure: \[Letters\]
Polyps regression
时间窗: from Baseline (W0) to Week 52.
Unit of Measure: \[Yes, No\]
次要结局
- Polyps regression, assessed by Indocyanine Green Angiography (ICGA);(from Baseline (W0) to Week 16)
- Presence of active polyps, assessed by Indocyanine Green Angiography (ICGA);(from Baseline (W0) to Week 52)
- Presence of fluid assessed on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 52;(from Baseline (W0) to Week 52)
- Frequency and severity of ocular and non-ocular adverse events over time.(from Baseline (W0) to Week 52)
- Presence of leakage based on fluorescein angiography (FA)(from Baseline (W0) to Week 52)
- Change in the Subfield Central Retinal Thickness (CRT), assessed by Spectral Domain-Optical Coherence Tomography (SD-OCT);(from Baseline (W0) to Week 52)
- Total number of treatments with Aflibercept;(from Baseline (W0) to Week 52)