EUCTR2013-001810-14-GB进行中（未招募）1 期
A PHASE III, MULTI-NATIONAL, MULTI-CENTER, RANDOMIZED, MASKED, CONTROLLED, SAFETY AND EFFICACY STUDY OF A FLUOCINOLONE ACETONIDE INTRAVITREAL (FAI) INSERT IN SUBJECTS WITH CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
pSivida Corporation0 个研究点目标入组 129 人开始时间: 2013年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 129
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
入选标准
- •Male or non-pregnant female at least 18 years of age at time of consent
- •One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration.
- •During the 12 months prior to enrollment (Day 1), the study eye has either received treatment:
- •o systemic corticosteroid or other systemic therapies given for at least 3 months, and/or
- •o at least 2 intra- or peri-ocular injections of corticosteroid for management of uveitis
- •OR the study eye has experienced recurrence:
- •o at least 2 separate recurrences of uveitis requiring systemic, intra- or peri-ocular injection of corticosteroid
- •At the time of enrollment (Day1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze = grade 2.
- •Visual acuity of study eye is at least 15 letters on the ETDRS chart
- •Subject is not planning to undergo elective ocular surgery during the study
- •Subject has ability to understand and sign the Informed Consent Form
- •Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
- •Are the trial subjects under 18? no
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Allergy to fluocinolone acetonide or any component of the FAI insert
- •History of posterior uveitis only that is not accompanied by vitritis or macular edema
- •History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze
- •Uveitis with infectious etiology
- •Vitreous hemorrhage
- •Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma)
- •Ocular malignancy in either eye, including choroidal melanoma
- •Toxoplasmosis scar in study eye; or scar related to previous viral retinitis
- •Previous viral retinitis
- •Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structure
- •Media opacity precluding evaluation of retina and vitreous
- •Peripheral retinal detachment in area of insertion
- •Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-20 mmHG) at Screening
- •Intraocular pressure (IOP) > 21 mmHg or concurrent therapy at screening with any IOP-lowering pharmacologic agent in the study eye
- •Chronic hypotony (< 6 mmHg)
- •Ocular surgery on the study eye within 3 months prior to study Day 1
- •Capsulotomy in study eye within 30 days prior to study Day 1
- •Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1
- •Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1
- •Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1
- •Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1
- •Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy
- •Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1
- •Subjects who test positive for human immune deficiency virus (HIV) or syphilis during screening
- •Mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis
- •Systemic infection within 30 days prior to study Day 1
- •Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study
- •Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study
- •Treatment with an investigational drug or device within
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