NCT05592912撤回1 期
Safety and Preliminary Efficacy of Two Dose Levels of HydroLenz as a Protectant for Vitrectomy-Induced Lens Opacities in Subjects Undergoing Vitrectomy
PromiSight, LLC0 个研究点目标入组 36 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 36
- 主要终点
- Evaluation of Changes in Lens Opacities
研究概览
简要总结
The primary objective of this study is to provide safety data for two different dosages of HydroLenz. Secondary objectives are to provide preliminary data to determine whether HydroLenz has the same effect in humans as it does in the porcine model; to confirm the reliability of methods for evaluating lens opacity; and, to acquire information that can be used to design the pivotal study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of any race.
- •65 years of age or older.
- •Study eye is phakic and scheduled for pars plana vitrectomy (23, 25, or 27 gauge) for epiretinal membrane or vitreomacular traction surgery.
- •Willingness and ability to comply with schedule for follow-up visits.
- •Subject understands the study requirements and the treatment procedures and provides signed, written informed consent obtained in accordance with the institutional review board (or ethics committee) requirements for this first-in-man early feasibility study.
排除标准
- •Aphakic or pseudophakic lens status in either or both eyes.
- •History of previous cataract surgery in either eye.
- •Evidence of congenital cataract.
- •Study eye with corneal opacity of one of the following LOCS III grades or condition that would confound the LOCS III grading results:
- •Inability to grade opacities in the study eye with LOCS III at the baseline exam;
- •Inability to dilate pupil to at least 6.0 mm;
- •LOCS III grade ≥ 2 for nuclear opalescence, cortical lens opacities, or posterior subcapsular lens opacities in the study eye at baseline.
- •Diabetic retinopathy or macular edema in the study eye.
- •Retinal vascular disease or retinopathy in the study eye.
- •History of previous intravitreal injections in the study eye.
- •History of previous subconjunctival injections in the study eye.
- •History of previous radiation in the study eye.
- •History of systemic, periocular, inhaled, or chronic topical corticosteroids.
- •Previous laser prophylaxis for retinal tear/hole/lattice degeneration in the study eye.
- •Previous pneumatic retinopexy or retinal detachment repair in the study eye.
- •Previous vitrectomy in the study eye.
- •Previous laser treatment anywhere in the study eye (trabecular meshwork, iris, retina, macula).
- •Use of silicone oil, air or gas tamponade during the vitrectomy in the study eye prior to injection of the HydroLenz.
- •Use of binocular indirect ophthalmoscopy laser during the procedure (endolaser is permitted).
- •History of any previous ocular surgery in the study eye.
- •Any ocular trauma resulting in lens opacity or subluxation of the lens in the study eye.
- •Iatrogenic lens trauma during surgery prior to injection of the HydroLenz.
- •Surgical plan for the vitrectomy includes planned glaucoma filtering or tube-shunt procedure or any procedure affecting the lens.
- •Female patients who are pregnant or lactating or plan to become pregnant during the course of the study.
- •A known sensitivity to study medications for which no alternative medication can be - prescribed.
- •Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the HydroLenz treatment or study participation or may confound the outcome of the study.
研究组 & 干预措施
Low dose HydroLenz treatment
Experimental
干预措施: HydroLenz Injection (Drug)
High dose HydroLenz treatment
Experimental
干预措施: HydroLenz Injection (Drug)
Control, i.e., no HydroLenz treatment
Placebo Comparator
干预措施: No HydroLenz Injection (Other)
结局指标
主要结局
Evaluation of Changes in Lens Opacities
时间窗: Baseline and 12 Months
The Lens Opacity Classification System, Version III (LOCS III) and the rate of lens related (cataract) surgery will be used to evaluate the lens opacities.
Changes in BSCVA
时间窗: Baseline and 12 Months
Number of eyes losing more than 2 lines of BSCVA
次要结局
未报告次要终点
研究者
相似试验
招募中
1 期
Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)Necrotizing EnterocolitisNCT06315738Noveome Biotherapeutics, formerly Stemnion36
已完成
2 期
Study to Determine the Dose, the Safety and Effectiveness of a New Drug, Modified Release rhTSH, in Patients With Multinodular GoiterMultinodular GoiterNCT00454220Genzyme, a Sanofi Company96
已完成
3 期
Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsChronic Troublesome SialorrheaPost-strokeTraumatic Brain InjuryParkinson's DiseaseNCT02091739Merz Pharmaceuticals GmbH184
已完成
2 期
Study of Drug to Reduce Thrombocytopenia in Patients Receiving Chemo for Ovarian, Fallopian Tube or Peritoneal CancerNeutropeniaAnemiaThrombocytopeniaLymphopeniaNCT00771810Tarix Pharmaceuticals34
已完成
1 期
Topical Resiquimod for the Treatment of Early Stage Cutaneous T Cell Lymphoma (CTCL)Cutaneous T Cell LymphomaNCT01676831Abramson Cancer Center at Penn Medicine13