EUCTR2010-023900-29-ES进行中（未招募）1 期
A 12-Month, Multicentre, Randomised, Parallel Group Study to Compare the Efficacy and Safety of Ozurdex® Versus Lucentis® in Patients with Branch Retinal Vein Occlusion.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 307
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
- •1. Male or female, ? 18 years of age
- •2. Written informed consent has been obtained
- •3. Written Data Protection Consent (European sites only) has been
- •4. Study eye must have clear ocular media and adequate pupil dilation to
- •permit good quality photographic imaging
- •5. ME secondary to BRVO in the study eye with all of the following
- •characteristics:
- •a) involving the centre of the macula (fovea)
- •b) central retina subfield thickness more or equal 320 ?m as assessed with Spectralis
- •optical coherence tomography (OCT) or more or equal 300 ?m as assessed with Cirrus OCT
- •c) less than 90 days from onset of BRVO symptoms to screening visit
- •d) visual acuity (VA) decrease attributable to retinal oedema
- •Note: Characteristics a and b will be confirmed by a CRC
- •6. Absence of severe macular ischemia (defined as an area of
- •nonperfusion > 4 disc areas [DA] which involve the foveal avascular
- •zone), as confirmed by a CRC
- •7. BCVA score of ? 20 to ? 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study
- •(ETDRS) visual acuity protocol at both the screening visit and day 1 visit.
- •8. Female subjects of childbearing potential must have a negative urine
- •pregnancy test at the screening (day -14) visit.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. History of a medical condition (disease, metabolic dysfunction,
- •physical examination finding or clinical laboratory finding) that, in the
- •opinion of the investigator, would preclude scheduled study visits,
- •completion of the study, or a safe administration of study medication.
- •2. Ocular hypertension unless controlled with monotherapy.
- •3. Pregnant or nursing (lactating) women, where pregnancy is defined
- •as the state of a female after conception and until the termination of
- •gestation, confirmed by a positive urine (human chorionic gonadotropin
- •[hCG] > 20 mIU/ml) or serum pregnancy test (hCG ? 5 mIU/ml).
- •4. Pre-menopausal women of child-bearing potential not using adequate
- •contraception. Women of child-bearing potential are defined as all
- •women physiologically capable of becoming pregnant. This includes
- •women whose career, lifestyle, or sexual orientation precludes
- •intercourse with a male partner and women whose partners have been
- •sterilized by vasectomy or other means unless they meet the following
- •definition of postmenopausal:12 months of natural (spontaneous)
- •amenorrhea or 6 months of spontaneous amenorrhea with serum
- •follicle-stimulating hormone levels of > 40 mIU/m or 6 weeks post
- •surgical bilateral oophorectomy with or without hysterectomy. Adequate
- •contraception is defined as one or more of the following methods:
- •surgical sterilization (eg, bilateral tubal ligation), hormonal
- •contraception (implantable, patch, oral), and double-barrier methods
- •(any double combination of intrauterine device, male or female condom
- •with spermicidal gel, diaphragm, sponge, or cervical cap). Acceptable
- •methods of contraception may include total abstinence at the discretion
- •of the investigator in cases where the age, career, lifestyle, or sexual
- •orientation of the subject ensures compliance. Periodic abstinence (eg,
- •calendar, ovulation, symptothermal, postovulation methods) and
- •withdrawal are not acceptable methods of contraception. Reliable
- •contraception should be maintained throughout the study and for 30
- •days after the administration of the last study drug injection.
- •Note: Instruct females of childbearing potential to immediately inform
- •the investigator if they become pregnant during the study. Should this
- •occur, the investigator shall immediately contact the Sponsor as detailed
- •in Sections 9.2 and 9.3 of the protocol.
- •5. Participation in an investigational drug or device study within 30 days
- •of the screening visit
- •6. Any current or history of ocular disease in the study eye other than
- •RVO that, in the opinion the investigator, may confound assessment of
- •the macula or affect central vision, such as exudative age-related
- •macular degeneration, geographic atrophy, diabetic retinopathy, uveitis,
- •angioid streaks, histoplasmosis, pathological myopia, retinal
- •detachment, epiretinal membrane, macular hole, or significant cataract
- •7. History of cataract surgery in either eye within the past 3 months
- •prior to the screening visit
- •8. History or evidence of serious ocular trauma or intraocular surgery
- •(such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy)
- •in the study eye within the past 6 months prior to the screening visit
- •9. History of severe or serious hypersensitivity to any components of the
- •test article or fluorescein dye.
- 另有 3 项未显示
研究者
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