jRCT2031230147已完成不适用
Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion (QUASAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 822
- 主要终点
- Change from baseline in BCVA measured by the ETDRS letter score at Week 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adult >=18 years of age (or countrys legal age of adulthood if the legal age is >18 years) at the time of signing the informed consent.
- •Treatment-naive macular edema involving the foveal center secondary to RVO (BRVO, HRVO, or CRVO) diagnosed within 16 weeks (112 days) before the screening visit in the study eye.
- •Early Treatment Diabetic Retinopathy Study BCVA letter score of 73 to 24 (20/40 to 20/320) at screening and baseline visits in the study eye.- Decrease in BCVA determined to be primarily the result of RVO in the study eye.
- •Mean CST >=00 um on optical coherence tomography (OCT) if excluding Bruchs membrane (e.g., Cirrus or Topcon) or >=320 um if including Bruchs membrane (e.g., Heidelberg Spectralis), confirmed by the reading center at the screening visit and by the site at baseline visit in the study eye.
- •Capable of giving signed informed consent form (ICF) by study participant or legally acceptable representative, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.- US participants will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws.
- •Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for participation in clinical studies and fulfil the conditions set on Section 10.4.2.
排除标准
- •Concurrent disease that causes substantial decrease of BCVA, is expected to limit BCVA recovery or is likely to require medical or surgical intervention during the study in the study eye.
- •Presence or history of the following ocular conditions:
- •Advanced age-related macular degeneration (neovascular AMD or geographic atrophy) in the study eye.
- •Diabetic macular edema or diabetic retinopathy, defined in diabetic participants as diabetic retinopathy lesions outside the area of the vein occlusion in the study eye and anywhere in the retina in the fellow eye.
- •Anterior segment neovascularization, vitreous hemorrhage, retinal detachment in the study eye.
- •Vitreomacular traction, epiretinal membrane or structural damage to the macula that is considered by the Investigator to significantly affect central vision or preclude improvement in vision in the study eye.
- •Macular hole of stage 2 and above in the study eye.
- •Myopia of a spherical equivalent of at least 8 diopters prior to any refractive or cataract surgery in the study eye.
- •Corneal transplant or corneal dystrophy in the study eye.
- •Idiopathic or autoimmune uveitis in the study or in the fellow eye.
- •Presence of the following ocular conditions at screening or baseline visit:
- •Significant media opacities, including cataract, that interfere with BCVA, or imaging assessments (e.g., fundus photography [FP], OCT) in the study eye.
- •Aphakia, or pseudophakia with absence of posterior capsule (unless it occurred as a result of a yttrium-aluminum-garnet [YAG] posterior capsulotomy performed more than 30 days before the screening visit), in the study eye.
- •Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication); or history or likely future need of glaucoma surgery in the study eye.
- •Intraocular inflammation/infection (including trace, or above, cells in the anterior chamber and/or vitreous) within 12 weeks (84 days) of the screening visit in the study or in the fellow eye.
- •Extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in the study or in the fellow eye.
- •Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg) at the screening visit or baseline visit.
- •Uncontrolled diabetes mellitus, defined by hemoglobin A1c (HbA1c) >12% at the screening visit.
- •History of cerebrovascular accident or myocardial infarction within 24 weeks (168 days) before the screening visit or between screening and baseline visits.
- •Renal failure requiring dialysis, or renal transplant at screening or potentially during the study.
- •Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for RVO in the study eye.
- •Previous administration of systemic anti-angiogenic medications for any condition.
- •Prior treatment of the study eye with any of the following drugs (any route of ophthalmic administration) or procedures:
- •Anti-angiogenic drugs at any time including investigational therapy (e.g., with anti-angiopoietin/anti-VEGF bispecific monoclonal antibodies).
- •Previous use topical steroids within 4 weeks (28 days) from the screening visit, or intraocular or periocular steroids within 16 weeks (112 days) from the screening visit, or steroid implants at any time.
- •Previous treatment with intraocular or periocular implant, gene therapy, or cell therapy at any time.
- •Treatment with ocriplasmin at any time.
- •Vitreoretinal surgery (including scleral buckling) at any time.
- •Any intraocular surgery, including cataract surgery, within 12 weeks (84 days) before the screening visit.
- •Previous treatment with retinal laser photocoagulation.
- •Prior treatment of the fellow eye with any of the following:
- •a. Gene therapy, or cell therapy in the fellow eye at any time.
结局指标
主要结局
Change from baseline in BCVA measured by the ETDRS letter score at Week 36
时间窗: At Week 36
Change from baseline in **BCVA** (Best Corrected Visual Acuity) measured by the **ETDRS letter score**
次要结局
未报告次要终点
研究者
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