A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Safety
研究概览
简要总结
The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).
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
- None
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
- •Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
- •Aged 50 years or older
- •Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye
排除标准
- •No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
- •History of or current clinical evidence in the study eye of:
- •diabetic macular edema
- •any ocular inflammation or infections
- •pathological myopia
- •retinal detachment
- •advanced glaucoma
- •significant media opacity, including cataract
- •History or evidence of the following surgeries in the study eye:
- •penetrating keratoplasty or vitrectomy;
- •corneal transplant;
- •corneal or intraocular surgery within 3 months of Screening
- •Uncontrolled hypertension despite use of antihypertensive medications
- •Participation in any investigational drug or device study, systemic or ocular, within past 3 months
- •Women who are pregnant or nursing
- •Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
研究组 & 干预措施
Stage 1 - Group 1
Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 1 - Group 2
Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 1- Group 3
Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 1- Group 4
Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 1 - Group 5
Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 2
Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks
干预措施: PAN-90806 Ophthalmic Solution (Drug)
Stage 2
Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks
干预措施: Lucentis (Drug)
结局指标
主要结局
Safety
时间窗: 3 months
Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes
次要结局
未报告次要终点