NCT01255462已完成1 期
A Multicenter, Open Label, Single Ascending Dose Study to Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 16
- 主要终点
- To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
研究概览
简要总结
This study will assess the safety, tolerability, and serum pharmacokinetics of intravitreal LFG316 in patients with advanced age-related macular degeneration.
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
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD
- •ETDRS best corrected visual acuity of 60 letters or worse in the study eye.
排除标准
- •Retinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.
- •Choroidal neovascularization due to a cause other than AMD.
- •In the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.
- •Any of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.
- •Any of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.
- •Any of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.
- •Participation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.
- •Any medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
时间窗: Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
次要结局
- To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.(Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study))
研究者
研究点 (16)
Loading locations...
相似试验
已完成
3 期
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular EdemaDiabetic Macular EdemaNCT00490815Alimera Sciences37
终止
2 期
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)Macular Degeneration, Age-RelatedGeographic AtrophyNCT03972709Genentech, Inc.372
已完成
1 期
Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular DegenerationDiabetic Macular EdemaNeovascular Age-related Macular DegenerationNCT04537884Unity Biotechnology, Inc.19
已完成
1 期
Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravitreal vMCO-I in Patients With Advanced Retinitis PigmentosaRetinitis PigmentosaRetinal DiseasesRetinal DegenerationNCT04919473Nanoscope Therapeutics Inc.11
已完成
2 期
Safety and Effects of a Single Intravitreal Injection of vMCO-010 Optogenetic Therapy in Subjects With Stargardt DiseaseStargardt DiseaseNCT05417126Nanoscope Therapeutics Inc.6