jRCT2071260009尚未招募不适用
A Phase 3, Multicenter, Single-arm Clinical Study to Assess the Safety and Tolerability of Intravitreal Administration of Pegcetacoplan in Japanese Participants with Geographic Atrophy Secondary to Age-related Macular Degeneration
未提供0 个研究点目标入组 20 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
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
- Single Arm Study
入排标准
- 年龄范围
- 40age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant must be of Japanese descent by birth based on self-reporting and investigator confirmation and have 4 Japanese grandparents.
- •The participant is aged >= 40 years.
- •The participant has normal-luminance BCVA (NL-BCVA) of 24 letters or better using early treatment diabetic retinopathy study charts (approximately 20/320 Snellen equivalent).
- •The participant has a clinical diagnosis of GA secondary to AMD as determined by the investigator and confirmed by the reading center.
- •The GA lesion must meet the following criteria as determined by the central reading center's assessment of fundus autofluorescence imaging at screening:
- •a. The total GA area must be >= 1.25 and <= 17.5 mm2 (1 and 7 disk areas, respectively).
- •b. If GA is multifocal, at least 1 focal lesion must be >= 1.25 mm2 (0.5 disk areas), with the overall aggregate area of GA as specified above in 5a.
- •c. The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
- •d. There is a presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (ie, pattern = none) is exclusionary.
- •There must be adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the investigator.
- •Female participants must be:
- •a. women of nonchildbearing potential, defined as postmenopausal women with 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg, age appropriate, history of vasomotor symptoms) or who have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential, or
- •b. women of childbearing potential with a negative serum pregnancy test at screening and must agree to use protocol-defined methods of contraception for the duration of the study and 90 days after their last dose of pegcetacoplan, and refrain from breastfeeding for the duration of the study.
- •Male participants:
- •a. must be surgically sterile or must agree to use highly effective contraception from screening through the duration of the study.
- •b. must refrain from donating sperm for the duration of the study and for 90 days after their last dose of pegcetacoplan.
- •c. with female partners of childbearing potential must agree to use protocol-defined methods of contraception for 90 days after their last dose of pegcetacoplan.
- •The participant is willing and able to give informed consent and to comply with the study procedures and assessments.
排除标准
- •The participant has GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy, or toxic maculopathies like plaquenil maculopathy in either eye.
- •The participant has aspherical equivalent of the refractive error demonstrating >6 diopters of myopia or an axial length >26 mm.
- •The participant has any history or active choroidal neovascularization (CNV), associated with AMD or any other cause, including any evidence of retinal pigment epithelium rips or evidence of neovascularization anywhere based on spectral domain optical coherence tomography (SD-OCT) imaging and/or fundus fluorescein angiography (FFA) as assessed by the reading center.
- •There is a presence of an active ocular disease that in the opinion of the investigator compromises or confounds visual function, including but not limited to, uveitis or other macular diseases (eg, clinically significant epiretinal membrane, full thickness macular hole or uncontrolled glaucoma/ocular hypertension). Benign conditions in the opinion of the investigator such as peripheral retina dystrophy are not exclusionary.
- •The participant has had intraocular surgery (including lens replacement surgery) within 3 months prior to screening.
- •The participant has a history of laser therapy in the macular region.
- •The participant has aphakia or an absence of the posterior capsule. Note: Yttrium aluminum garnet laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary.
- •The participant has any ocular condition other than GA secondary to AMD that may require surgery or medical intervention during the study period or, in the opinion of the investigator, could compromise visual function during the study period.
- •The participant has any contraindication to IVT injections including current ocular or periocular infection.
- •The participant has a history of prior IVT injection.
- •The participant has previously been in another interventional clinical study for IVT therapies in either eye (including participants receiving sham).
- •The participant has previously been in another interventional clinical study for GA in either eye including investigational oral medication, sham, and placebo.
- •The participant has had any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- •The participant has any medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 12-month treatment period unlikely, or would make the participant an unsafe study candidate.
- •The participant has any screening laboratory value (hematology, serum chemistry, or urinalysis) that in the opinion of the investigator is clinically significant and not suitable for study participation.
- •The participant has a known hypersensitivity to fluorescein sodium for injection or hypersensitivity to pegcetacoplan or any of the excipients in pegcetacoplan solution.
- •The participant is pregnant or breastfeeding.
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