NCT07607561尚未招募2 期
A Randomization, Double-blind, Placebo-controlled, Parallel, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
SCAI Therapeutics0 个研究点目标入组 50 人开始时间: 2026年11月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
研究概览
简要总结
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
详细描述
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Subjects who meet the inclusion/exclusion criteria will be randomized in 2:2:1 ratio into SCAI-005 0.04% and SCAI-005 0.08% and Placebo group.
Efficacy will be assessed at Weeks 4, 8, and 12. Safety and tolerability will be assessed until 12 weeks after randomization.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50 years or older
- •Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product.
- •Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening
- •CST ≤ 450 μm at screening
- •BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening
排除标准
- •Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
- •Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening
- •Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area
- •History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy [PDT], laser photocoagulation, etc.) in the study eye
- •Subjects with vitreous hemorrhage in the study eye
- •History of ocular treatment (except for anti-VEGF IVT therapy), systemic treatment, or surgical intervention for the treatment of neovascular age-related macular degeneration (nAMD) in the study eye
- •Administration of intraocular, periocular, or intravitreal (IVT) steroid injection in the study eye within 24 weeks prior to Screening
- •Presence of diabetic retinopathy, diabetic macular edema, or other vascular diseases affecting the retina, other than neovascular age-related macular degeneration (nAMD), in either eye
- •History of endophthalmitis or idiopathic or autoimmune-related uveitis in either eye
- •Subjects with active macular neovascularization identified in the fellow eye at Screening
研究者
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