A Randomized, Double Masked, Uncontrolled , Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants With Neovascular Age-Related Macular Degeneration (AMD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 16
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
Double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular PAN 90806 administered once daily for 12 weeks.
详细描述
Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks.
Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking will be maintained by using a coded drug supply.
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
- •Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
- •Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study
- •Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea
- •History of or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and/or 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
- •Women of child-bearing potential who are not using a highly effective form of birth control
- •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
PAN-90806 Eye Drops, dose 1
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
干预措施: PAN-90806 Ophthalmic Suspension (Drug)
PAN-90806 Eye Drops, dose 2
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
干预措施: PAN-90806 Ophthalmic Suspension (Drug)
PAN-90806 Eye Drops, dose 3
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
干预措施: PAN-90806 Ophthalmic Suspension (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: up to 12 weeks
次要结局
- Mean change from baseline in study eye ETDRS Visual Acuity(through Week 12)
- Mean change from baseline in study eye retinal thickness(through Week 12)
- Number of patients needing additional treatment with ranibizumab(through Week 12)