EUCTR2005-001589-15-GB进行中（未招募）1 期
A multi-center study evaluating the safety of a replacement intravitreal fluocinolone acetonide (FA) (0.59 mg) implant in patients with non-infectious posterior uveitis who were previously treated with an intravitreal FA implant
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria to be eligible for enrollment:
- •Implanted patients who have completed approximately 30 months in the 415-002
- •trial and have experienced a recent recurrence of uveitis, and in the opinion of the
- •Investigator and the Bausch & Lomb Medical Monitor, would benefit from a
- •replacement implant.
- •AND AT THE TIME OF IMPLANTATION, THE STUDY EYE MUST HAVE:
- •< 10 anterior chamber cells (A/C) /high-powered field (HPF) and vitreous haze <2
- •NOTE: Patients may be treated prior to entry in order to qualify. The objective is to obtain a relatively quiet eye prior to surgery for implantation of implant. All eyes must satisfy this requirement.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients are not eligible for enrollment in this study if any of the following are applicable:
- •1. Patient who was randomized in the standard of care group in BLP415-002 study
- •2. Patient whose previous FA implant was removed due to uncontrolled IOP
- •3. Presence of vitreous hemorrhage
- •4. Presence of a recent toxoplasmosis scar in the eye
- •5. Peripheral retinal detachment
- •6. Media opacity precluding evaluation of the retina and vitreous
- •7. Intraocular pressure (IOP) increase to > 25 mmHg that could not be reduced
- •to 21 mmHg or less by either medical or surgical means.
- •An IOP increase requiring medical or surgical intervention must have a
- •successful outcome (reduction to 21 mmHg or less) lasting at least 3 months
- •prior to enrollment.
- •9. Ocular surgery and /or trauma on the study eye within 3 months prior to
- •enrollment or trabeculoplasty or YAG laser within one month prior to enrollment
- •10. Female pregnant, lactating, or of childbearing potential considering
- •becoming pregnant during the course of the study and those not taking
- •effective contraception/precautions to avoid pregnancy
- •11. Patient for whom, in the physician’s opinion, any of the protocol procedures
- •may pose a special risk not outweighed by the potential benefits of participating
- •in the study.
- •12. Uveitis of infectious etiology
- •13. Patient who has been tested positive for human immunodeficiency virus.
- •14. Patient who is currently enrolled in any other clinical study or who has
- •participated in any clinical study other than BLP415-002 within 1 month of
- •enrollment.
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