A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Observation of dose limiting toxicity.
研究概览
简要总结
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
详细描述
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
The specific objective of this six-month study is to evaluate the safety and efficacy of three monthly ophthalmic intravitreal injections of ALG-1001 in human subjects with Wet AMD, and to follow these subjects for an additional four months off-treatment. Three cohorts have been established as part of the study design, utilizing three different doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Male or female subjects, 50 years of age or older.
- •Active wet macular degeneration (AMD).
- •Subfoveal CNV (choroidal neovascular membrane) secondary to AMD in the study eye less than or equal to 12 MPS disc areas.
- •CNV greater than 50% of lesion area.
- •CNV may be classic, minimally classic, or occult.
- •For minimally classic and occult lesions in the study eye, must demonstrate decrease in BCVA (best corrected visual acuity) that must be assessed based on clinical exploration, macular thickening, presence of subretinal fluid or hemorrhage, and/or OCT findings consistent with CNV.
- •Study eye has a BCVA of 20/50 to 20/320 ETDRS (Early Treatment Diabetic Retinopathy Study )equivalent (65 letters to 23 letters), which in the opinion of the investigator is primarily due to Wet AMD.
- •Decrease in BCVA must be assessed based on clinical exploration, macular thickening, and/or fluorescein angiography consistent with CNV.
- •Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm.
- •Willing and able to return for all study visits.
- •Able to meet the extensive post-op evaluation regimen.
- •Patient can understand and sign informed consent form.
- •If subject is a female less than 60 years old, negative pregnancy test during the screening window.
排除标准
- •Media opacities or abnormalities that would preclude observation of the retina.
- •Other retinal pathologies that would interfere with the patient's vision.
- •Presence of other causes of CNV, including pathologic myopia, OHS (ocular histoplasmosis syndrome), angioid streaks, choroidal rupture or multifocal choroiditis in the study eye.
- •RPE (retinal pigment epithelium) rip or tear in the study eye.
- •Patients with current or prior retinal detachments, retinal tears, or tractional detachments in either eye.
- •A history of cataract surgery complications/vitreous loss in the study eye.
- •A history of penetrating ocular trauma in the study eye.
- •Chronic or recurrent uveitis.
- •Has undergone a vitrectomy (anterior or pars plana) in the study eye.
- •Ongoing ocular infection or inflammation in either eye.
- •A history of intravitreal injections of any type in the study eye within the last 45 days prior to study enrollment.
- •A history of cataract surgery complications/vitreous loss in the study eye.
- •Congenital malformations in the study eye.
- •Mentally handicapped.
- •Pregnant or a nursing female.
- •Currently participating in any other clinical research study
- •Contraindication to the study medication.
研究组 & 干预措施
Arm 4.0 mg ALG -1001
Arm 3 4.0 mg ALG -1001 per 50ul
干预措施: ALG 1001 (Drug)
Arm 1.5 mg ALG - 1001
Arm 1.5 mg ALG- 1001 per 50ul
干预措施: ALG 1001 (Drug)
Arm 2.5 mg ALG -1001
Arm 2.5 mg ALG -1001 per 50ul
干预措施: ALG 1001 (Drug)
结局指标
主要结局
Observation of dose limiting toxicity.
时间窗: 6 months
The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. The determination will be made by ocular adverse events by standard clinical ophthalmic evaluation, visual acuity changes at baseline by slit lamp biomicroscopy, tonometry, indirect ophthalmoscopy/ fundus photography, fluorescein angiography, OCT (optical coherence tomography) central macular thickness.
次要结局
- Changes in OCT central macular thickness(6 months)