A Phase II Trial to Evaluate the Efficacy and Safety of Topical Ocular MG-O-1002 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Mean change from baseline in central macular thickness over 12 weeks.
研究概览
简要总结
A 2 parts Phase II study to investigate the effect on central macular thickness of treatment with MG-O-1002 eye drops in participants aged over 45 with neovascular age-related macular degeneration (nAMD)
详细描述
Neovascular Age-related Macular Degeneration (nAMD) is a serious eye disease and a leading cause of irreversible blindness primarily in the older population. Current treatment with anti-vascular endothelial growth factor (VEGF), while effective, requires intravitreal injection meaning administration that needs to be performed by a specialist ophthalmologist and carries procedural risks. MG-O-1002 can be administered as a topical eye drop providing a potentially safer option that can be self-administered increasing accessibility. This study will evaluate the efficacy and safety of topical ocular use of MG-O-1002 in participants with nAMD.
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
- Single (Participant)
盲法说明
Part 1 - Open Label (24 Participants); Part 2 - Single-Blind to Participant (12 Participants)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 45 years or older with a diagnosis of nAMD
- •Diagnosis in the study eye of active, pathologic, newly diagnosed and treatment naïve (i.e., no previous anti-VEGF treatment or other surgery in the study eye)
- •Visual acuity from 20/25 to 20/200 in the study eye
- •Total lesion size (including neovascularization, blood) ≦12 disc areas (30.5 mm2) as assessed by Fluorescein Angiography.
- •Demonstrate the ability, or have a family member who is willing and able to, instill topical ocular drops in the study eye.
- •Ability to give written informed consent and comply with study procedures.
- •Adults aged 45 years or older with a diagnosis of nAMD.
- •Participant with nAMD previously treated with 3 injections of Aflibercept within the preceding 4 months, and received the last injection within 30 to 21 days before visit 1 of this study.
- •Demonstrate the ability, or have a family member who is willing and able to, instil topical ocular drops in the study eye.
- •Ability to give written informed consent and comply with study procedures.
排除标准
- •Prior use within the last 2 months, or a high possibility of requiring treatment with anti-VEGF therapy (except the study drug) in both eyes during the study.
- •Abnormal regions identified by Fundus Autofluorescence (FAF) and Optical Coherence Tomography (OCT) involving the center of the fovea are caused by retinal pigment epithelium (RPE) atrophy, RPE tear, photoreceptor attenuation, or fibrosis/scar tissue.
- •Significant retinal serous pigment epithelial detachment (PED) involving the fovea.
- •History of, or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infection, 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 the use of antihypertensive medications.
- •Diagnosis of Type 1 or Type 2 diabetes.
- •Use of medications that in the opinion of the Investigator could interfere with study results.
- •Participation in any investigational drug or device study, systemic or ocular, within the past 3 months.
- •Women who are pregnant or breast feeding.
- •Women of child-bearing potential who are not using an effective form of birth control.
- •Known serious allergies or hypersensitivity to the fluorescein dye used in angiography, or to the components of the MG-O-1002 formulation, or to topical anesthetics.
- •In the opinion of the investigator, subject who is not suitable for or not likely be benefited from the study treatment.
- •More than 30 days between 3rd injection of Aflibercept and Visit
- •Patients who have received 3 injections of Aflibercept within the last 3 months and need continued treatment in the fellow eye.
- •Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea.
- •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.
- •Active intraocular inflammation or uveitis or scleritis or episcleritis in the study eye or ocular or periocular infection in either eye.
- •Uncontrolled hypertension despite the use of antihypertensive medications.
- •Diagnosis of Type 1 or Type 2 diabetes.
- •Use of medications that in the opinion of the Investigator could interfere with study results.
- •Participation in any investigational drug or device study, systemic or ocular, within the past 3 months.
- •Women who are pregnant or breast feeding.
- •Women of child-bearing potential who are not using an effective form of birth control.
- •Known serious allergies or hypersensitivity to the fluorescein dye used in angiography, or to the components of the MG-O-1002 formulation, or to topical anesthetics.
- •In the opinion of the investigator, subject who is not suitable for or not likely be benefited from the study treatment.
研究组 & 干预措施
Part 1 (MG-O-1002)
Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular
干预措施: MG-O-1002 (Drug)
Part 2 (MG-O-1002 or Placebo)
Arm 1:
Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular
Arm 2:
Drug: Placebo; Dosage form: ophthalmic solution; Route of administration: topical ocular
干预措施: MG-O-1002 (Drug)
Part 2 (MG-O-1002 or Placebo)
Arm 1:
Drug: MG-O-1002; Dose level: 0.8%; Dosage form: ophthalmic solution; Route of administration: topical ocular
Arm 2:
Drug: Placebo; Dosage form: ophthalmic solution; Route of administration: topical ocular
干预措施: Placebo (Other)
结局指标
主要结局
Mean change from baseline in central macular thickness over 12 weeks.
时间窗: up to 12 weeks
次要结局
- Mean Change from baseline in Visual Field over 12 weeks(up to 12 weeks)
- Mean change from baseline in Best-Corrected Visual Acuity over 12 weeks(up to 12 weeks)
- Mean change from baseline in total area of Choroidal Neovascularization (CNV) over 12 weeks(up to 12 weeks)
- The time to rescue treatment for needed patients within 12 weeks(up to 12 weeks)
- The number of patients needing rescue treatment within 12 weeks(up to 12 weeks)
- Incidence and severity of ocular and systemic adverse events(up to 12 weeks)