EUCTR2020-000676-38-CZ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
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, and
- •tubal ligation. A woman of non-childbearing potential is defined as follows:
- •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 following:
- •- 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 confirmed
- •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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