EUCTR2019-003421-22-NL进行中（未招募）1 期
EXPLORE: A phase 2, outcomes assessor-masked, multicentre, randomised study to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with geographic atrophy secondary to age-related macular degeneration
Gyroscope Therapeutics0 个研究点目标入组 202 人开始时间: 2023年7月26日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Able and willing to give written informed consent
- •2. Age =55 years
- •3. Have a clinical diagnosis of GA secondary to AMD in the study eye, as determined by the Investigator, and a diagnosis of AMD in the contralateral eye (except if the subject is monocular)
- •4. Have GA lesion(s) total size between or equal to 1.25mm2 to 17.5mm2 in the study eye
- •5. The GA lesion in the study eye must reside completely within the FAF image
- •6. Up to 25% of the enrolled study population are permitted to have CNV in the fellow eye, defined as either:
- •a. Non-exudative/sub-clinical fellow eye CNV identified at Screening, or
- •b. Known history of fellow eye CNV with either =2 years since diagnosis
- •or with no active treatment required in 6 months prior to Screening
- •7. Have a BCVA of 24 letters (6/95 and 20/320 Snellen acuity equivalent) or better, using ETDRS charts, in the study eye
- •8. Part 1 Only: Subjects carrying a CFI rare variant genotype (minor allele frequency of = 1%) previously associated with low serum CFI or subjects carrying an unreported CFI rare variant genotype that have tested to have a low serum CFI.
- •9. Able to attend all study visits and complete the study procedures
- •10. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation. A pregnancy test is not required for postmenopausal women (defined as being at least 12 consecutive months without menses) or those surgically sterilised (those having a bilateral tubal ligation/bilateral salpingectomy, bilateral tubal occlusive procedure, hysterectomy, or bilateral oophorectomy)
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 192
排除标准
- •1. Subjects who have a clinical diagnosis of Stargardt Disease or other retinal dystrophies confirmed by the central reading centre
- •2. Have a history, or evidence, of CNV in the study eye
- •3. Presence of moderate/severe or worse non-proliferative diabetic retinopathy in the study eye
- •4. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in the study eye
- •5. History of intraocular surgery in the study eye within 12 weeks prior to Screening (Visit 1). Yttrium aluminium garnet capsulotomy is
- •permitted if performed >10 weeks prior to Visit 1
- •6. Have clinically significant cataract that may require surgery during the study period in the study eye
- •7. Presence of moderate to severe glaucomatous optic neuropathy in the study eye, uncontrolled intraocular pressure (IOP) despite, the use of
- •more than two topical agents, a history of glaucoma-filtering or valve surgery
- •8. Axial myopia of greater than -8 diopters in the study eye
- •9. Have any other significant ocular or non-ocular medical or psychiatric condition which, in the opinion of the Investigator, may either put the
- •subject at risk or may influence the results of the study
- •10. Have a contraindication to the specified protocol corticosteroid regimen
- •11. Have received any investigational and/or approved product(s) for the treatment of GA within the past 6 months, or 5 half-lives (whichever
- •is longer) other than nutritional supplements such as the age-related eye disease study (AREDS) formula in the study eye or systemically
- •12. Have received a gene or cell therapy at any time
- •13. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
- •14. Active malignancy within the past 12 months, except for: appropriately treated carcinoma in situ of the cervix, non-melanoma skin
- •carcinoma, or prostate cancer with a stable prostate-specific antigen (PSA) =12 months
研究者
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