EUCTR2020-000676-38-HR进行中（未招募）1 期
A Phase 3 Multicenter, Randomized, Double Masked, Sham-Controlled Clinical Trial to Assess the Safety and Efficacy of IntravitrealAdministration of Zimura (Complement C5 Inhibitor) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration - GATHER2
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •Ophthalmic Inclusion Criteria
- •The following inclusion criteria apply to the study eye (SE), one study
- •eye per patient. If both eyes satisfy the inclusion criteria, it is in the investigator's
- •discretion to determine the SE.
- •- Non-foveal GA secondary to dry AMD.
- •- The atrophic lesion must be able to be photographed in its entirety.
- •- Best corrected visual acuity in the SE between 20/25 – 20/320, inclusive.
- •General Inclusion Criteria
- •- Patients of either gender aged = 50 years.
- •- For patients who are women of childbearing potential involved in any
- •sexual intercourse that could lead to pregnancy, the patient has used a
- •protocol approved highly effective contraceptive method during the trial
- •and agrees to continue the same method until at least 90 days following
- •the last dose of test medication. Protocol approved highly effective
- •contraceptive methods are hormonal contraceptives (i.e., combined oral
- •contraceptive, patch, vaginal ring, injectable, or implant), intrauterine
- •devices or intrauterine systems, abstinence as defined by refraining from
- •heterosexual intercourse during the entire period of the study and until
- •at least 90 days following the last dose of study medication, vasectomy,
- •tubal ligation. A woman of non-childbearing potential is defined as
- •A woman who has had surgical sterilization (hysterectomy, bilateral
- •oophorectomy, or bilateral salpingectomy)
- •A woman = 60 years of age
- •A woman = 40 and < 60 years of age who fulfills at least one of the
- •- A cessation of menses for at least 12 months and a folliclestimulating
- •hormone (FSH) test confirming non-childbearing potential (refer to
- •laboratory reference ranges for confirmatory levels)
- •- A cessation of menses for at least 24 months without FSH levels
- •If the patient is a woman of childbearing potential, she must have a
- •negative serum pregnancy test within 14 days prior to the first injection
- •and have no plans to donate ova during the duration of the trial and at
- •least 90 days following the last dose of test medication. Ireland, Slovakia, United Kingdom,
- •Czech Republic, Poland, France, Italy: If the patient is male, he should
- •use a condom and not donate sperm during the time of study drug
- •exposure and for 90 days following the last exposure of study drug
- •- Provide written informed consent.
- •- Ability to return for all trial visits.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 320
排除标准
- •Patients will not be eligible for the trial if patients cannot attend all trial required visits, or if any of the following criteria are present systemically or in the SE:
- •Ophthalmic Exclusion Criteria
- •The following exclusion criteria apply to the SE:
- •Evidence of CNV in either eye.
- •- Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals.
- •- Any ocular condition in the SE that would progress during the course of the study that could affect central vision or otherwise be a confounding factor.
- •- Presence of other causes of choroidal neovascularization
- •- Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
- •- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
- •- Any sign of diabetic retinopathy in either eye.
研究者
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