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Safety Study of a Topical Treatment for Dry Age Related Macular Degeneration

2014年4月17日 更新者:MacuCLEAR, Inc.

A Phase 1 Randomized, Double-masked, Vehicle-controlled, Dose Escalation Study of the Ocular Safety and Tolerability of MC-1101 in Medically Stable Individuals

Study to evaluate the safety and tolerability of MC-1101, a potential topical treatment for non-edxudative age Related Macular Degeneration (AMD) in medically stable individuals.

研究概览

详细说明

MC-1101 is a topical version of a previously approved anti-hypertensive drug that is intended to increase choroidal blood flow.

  • A reduction of choroidal blood flow has been identified in patients with AMD
  • This study will evaluate 0.5% and 1.0% potencies of MC-1101 delivered 2X per day.

研究类型

介入性

注册 (实际的)

20

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Artesia、California、美国、90701
        • Sall Eye Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 85年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Subjects ≥ 50 and ≤ 85 years of age.
  2. Women must be post-menopausal or surgically sterilized for 1 year or longer.
  3. Best corrected distance visual acuity of 1.0 logMAR of better in each eye (20/200 Snellen equivalent).
  4. Able and willing to sign informed consent and HIPAA authorization, follow study instructions and complete all study visits. A study visit may require several exams during the course of the day.
  5. Able and willing to discontinue the use of all ocular medication(s) except for artificial tears at least one week prior to receiving the study treatment and for the entire course of the study.
  6. General good health, as evaluated by the investigator, based on the medical history provided by the subject and any adjunctive testing carried out at the investigator's discretion.

Exclusion Criteria:

Ophthalmic:

  1. Previous intravitreal injections of anti-VEGF therapies in either eye.
  2. History of diabetes and or diabetic retinopathy > 10 years.
  3. Ocular of laser surgery in either eye within 3 months of Visit 1.
  4. Ocular injection in either eye of any medication within 3 months of Visit 1.
  5. History of incisional glaucoma surgery in either eye.
  6. Corneal, cataract or media opacification in either eye which limits an adequate view of the fundus in the opinion of the investigator.
  7. Contraindications to pupil dilation in either eye.
  8. Any ocular disease that requires ongoing treatment with topical ocular agents in either eye during the study. Patients using intermittent ocular medications must stop these medications for one week prior to Visit 2. Use of artificial tears 3 times daily or less for mild dry eye disease is allowed, but must not occur within ± 15 minutes from dosing of the investigational product).
  9. Corneal disease, corneal irregularity or scarring that in the opinion of the investigator would make it difficult to accurately measure intraocular pressure (IOP) or visualize intraocular anatomy in either eye.
  10. Presence of a Hudson-Stahli line in the corneal epithelium in either eye.

General/Systemic:

  1. Female subjects who are menstruating.
  2. Prior participation (participation is defined as being randomized to an investigational product) in any other study in the last 30 days.
  3. Subjects unable to administer or have a caretaker administer the study eye drops.
  4. Subjects who are unable to follow instructions or are unwilling and considered physically unable to return for all study visits for the duration of the study.
  5. Clinically significant systemic disease that in the opinion of the investigator would interfere with the subject's ability to comply with the study requirements and or interpretation of the study results.
  6. Clinically significant abnormal results of laboratory tests, available to the investigator, which in the investigator's judgment would prohibit the subject from safe participation in this trial.
  7. Current or past use (more than 30 days) of chloroquine, hydroxychloroquine, chlorpromazine, thioridazine, quinine sulfate, clofazamine, cisplatin, carmustine, or deferoxamine.
  8. Uncontrolled blood pressure with systolic value ≥ 170 and diastolic ≥ 100 mmHg. Repeated measurements are allowed if in the investigator's opinion the time interval between recent antihypertensive medication dosing and blood pressure measurements was insufficient to provide for efficacious hypertension reduction.
  9. Subjects likely to undergo changes in systemic medications. All medications taken on a chronic basis must be stable for 30 days prior to Visit 2. Medications for an acute illness used within 30 days of Visit 1 must be discontinued prior randomization.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Drug, MC-1101
One eye drop of Active comparator, 0.5% MC-1101, 2 times per day, 28 days; followed by one drop of 1% MC-1101, 2 times per day, 28 days.
One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo
安慰剂比较:Placebo
One eye drop of Placebo comparator to MC-1101. Placebo contains all components of MC-1101 except for the active ingredient.
One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
No significant ocular or systemic adverse events in any of the 20 study subjects
大体时间:56 total days
Assess the safety and tolerability of MC-1101 by evaluating the local ocular and systemic safety of MC-1101 0.5 % and 1 % in subjects in a dose escalation manner over 8 weeks of daily ocular exposure.
56 total days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ken Sall, MD、Sall Eye Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2013年11月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2013年8月7日

首先提交符合 QC 标准的

2013年8月12日

首次发布 (估计)

2013年8月14日

研究记录更新

最后更新发布 (估计)

2014年4月21日

上次提交的符合 QC 标准的更新

2014年4月17日

最后验证

2014年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MC-1101-002

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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