CTRI/2017/11/010451Other3 期
SAPPHIRE: A randomized, Masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 460
- 试验地点
- 12
- 主要终点
- To demonstrate that suprachoroidal (SC) CLS-TA administered in conjunction with intravitreal
研究概览
简要总结
This is a randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion. The quaified subjects will be divided into two groups. Active group will receive IVT Aflibercept + CLS-TA
Control group will receive IVT Aflibercept + CLS-TA Sham
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Has a clinical diagnosis of RVO in the study eye within less than or equal to 9 months screening;
- •Has a CST of greater than or equal to 300 micro metre in the study eye as measured by spectral-domain optical coherence tomography (SD-OCT) with or without intraretinal or subretinal fluid and confirmed by the central reading center (CRC);
- •Has an ETDRS BCVA score of greater than or equal to 20 letters read and less than or equal to 70 letters read in the study eye;
- •Is naïve to local pharmacologic treatment for RVO in the study eye;
- •Is at least 18 years of age, understands the language of the informed consent and is willing and able to provide written informed consent before any study procedures, and is willing to comply with the instructions and attend all scheduled study visits.
排除标准
- •Has ME with etiology other than RVO;
- •Has, in the study eye, used any topical ocular corticosteroid in the 10 days before treatment at Visit 2 (Day 0); has at any time received any intraocular or periocular corticosteroid injection, an OZURDEX® implant, a RETISERT® implant, or an ILUVIEN® implant;
- •Has evidence of or history of any ophthalmic condition in the study eye that may have an associated neovascularization or edema component including, but not limited to, age-related macular degeneration (AMD), diabetic retinopathy, diabetic macular edema (DME), retinal detachment, central serous chorioretinopathy, scleritis, optic neuropathy, or retinitis pigmentosa;
- •Has a history of rubeosis irides or other neovascularization in the study eye; any active vitreous hemorrhage in the study eye within the last 90 days;
- •Has a history of any vitreoretinal surgery (scleral buckle placement, pars plana vitrectomy, retrieval of dropped nucleus or intraocular lens, sheathotomy) ever in the study eye or any ocular surgery in the 3 months before randomization.
- •Prior cataract extraction or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy is allowed but must have been performed at least 3 months before Visit 2 (Day 0);
- •Has a history of an ocular procedure or condition in the study eye within the 3 months before randomization that, in the Investigator’s opinion, could compromise globe or retinal integrity (eg, staphyloma, high myopia, predisposition to scleral thinning);
- •An ocular condition in the study eye that, in the opinion of the Investigator, would put the subject at risk due to study treatment or procedures (eg, active ocular infection, history of a SC hemorrhage, chalazion, significant blepharitis);
- •Has scarring from laser photocoagulation in the study eye that would compromise visual acuity;
- •Has had more than 3 macular laser photocoagulation treatments; or has had photocoagulation or cryotherapy in the study eye within the 6 months before Visit 2 (Day 0);
- •Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
- •This includes cataract that is felt to be a major contributor to reduced visual acuity and/or likely to undergo surgical repair within 3 months of randomization;
- •Has a IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not excluded if IOP is < 22 mmHg in the study eye with no more than 1 IOP-lowering medication as long as there is no history of glaucoma and the subject has a normal optic nerve and no evidence of visual field loss;
- •Has a history of glaucoma surgery (filtration surgery/trabeculectomy or tube shunt) in the study eye; has a history of laser trabeculoplasty or MIGs surgery in the study eye;
- •Has a history of clinically significant IOP elevation in response to corticosteroid treatment (“steroid responderâ€); General Exclusion Criteria Individuals are ineligible for participation in this study if he/she meet the following criteria:
- •Is a female subject who is pregnant, lactating or planning a pregnancy or is a female subject of childbearing potential who does not agree to submit to a pregnancy test at Screening; Females of childbearing potential must agree to use an acceptable method of contraception throughout participation in the study.
- •Acceptable methods of contraception include double barrier methods (condom with spermicide or diaphragm with spermicide), hormonal methods (oral contraceptives; implantable, transdermal, or injectable contraceptives), or an intrauterine contraceptive device with a documented failure rate of less than 1% per year.
- •Abstinence may be considered an acceptable method of contraception at the discretion of the Investigator, but the subject must agree to use one of the acceptable birth control methods if she becomes sexually active;
- •Has any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (eg, infection, uncontrolled elevated blood pressure,cardiovascular disease, poor glycemic control) or put the subject at risk due to study treatment or procedures; NOTE: Uncontrolled BP at screening may be treated before Visit 2;
- •Has a myocardial infarction or stroke within 90 days of treatment;
- •Has a likely need for hospitalization or surgery within the study period, including planned elective surgery or hospitalization;
- •Has a known hypersensitivity to any component of the formulation of TA,aflibercept, fluorescein, topical anesthetics, or the antiseptic used to prepare the eye for injection according to the Investigator’s standard practice;
- •Is currently enrolled in an investigational drug or device study or has used an investigational drug within 30 days of entry into this study or participated in an ocular device study in the last 90 days.
结局指标
主要结局
To demonstrate that suprachoroidal (SC) CLS-TA administered in conjunction with intravitreal
时间窗: Baseline to 8 weeks
(IVT) aflibercept is superior to IVT aflibercept alone in the proportion of subjects demonstrating more than or equal to 15 letters improvement in best corrected visual acuity (BCVA) two months after Baseline
时间窗: Baseline to 8 weeks
次要结局
- 1 To determine the effect of SC CLS-TA administered in conjunction with IVT aflibercept on mean(change from Baseline in BCVA)
研究者
研究点 (12)
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