A Phase 1/2, Open-Label, Dose-Escalation, Single Center, Clinical Study of MTP-131 (Ocuvia™) Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Incidence and severity of systemic and ocular adverse events
研究概览
简要总结
This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 and ≤ 80 years
- •Women of childbearing potential must have a negative urine pregnancy test at Baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug.
- •DME Treatment Group:
- •Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
- •BCVA (ETDRS) no better than 20/25 in the study eye
- •BCVA (ETDRS) no worse than 20/640 in either eye
- •AMD Treatment Group:
- •Non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced AMD (i.e., no choroidal neovascularization or macular atrophy)
- •BCVA (ETDRS) no worse than 20/400 in either eye
排除标准
- •Inability to self-administer eye drops
- •Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine [Plaquenil], tamoxifen, phenothiazines and ethambutol)
- •Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations
- •Have a glycosylated hemoglobin (HbA1c) ≥ 12%
- •Ocular Conditions:
- •Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination
- •Ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Low Dose Regimen
MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye
干预措施: MTP-131 (Drug)
High Dose Regimen
MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye
干预措施: MTP-131 (Drug)
结局指标
主要结局
Incidence and severity of systemic and ocular adverse events
时间窗: From Baseline to Day 28
Change from Baseline in vital sign measurements
时间窗: From Baseline to Day 28
Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale
时间窗: From Baseline to Day 28
Change from Baseline in slit lamp examinations
时间窗: From Baseline to Day 28
Change from Baseline in intraocular pressure
时间窗: From Baseline to Day 28
Change from Baseline in dilated fundoscopic examinations
时间窗: From Baseline to Day 28
Change from Baseline in central subfield thickness
时间窗: From Baseline to Day 28
次要结局
- Change in central subfield thickness(From Baseline to Day 28)
- Change from Baseline in widefield angiography(From Baseline to Day 28)
- Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy(From Baseline to Day 28)
- Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale(From baseline to Day 28)