EUCTR2020-002431-30-IE进行中（未招募）1 期
HORIZON: A Phase II, open-label, outcomes-assessor masked, multicentre, randomised,controlled 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 dry age-related macular degeneration
Gyroscope Therapeutics0 个研究点目标入组 250 人开始时间: 2021年9月29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
- 250
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. a. In Stage 1: 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)
- •b. In Stage 2: Have a clinical diagnosis of GA, secondary to AMD in the study eye, as determined by the Investigator, that is non-foveal, as determined by the central reading centre, or has a CFI rare variant
- •genotype associated with normal or low serum CFI, and meets inclusion criteria 3a (e.g., foveal or non-foveal GA), 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 1.25 mm2 to 17.5 mm2 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 or 20/320 Snellen acuity equivalent), using ETDRS charts, in the study eye
- •8. Meet one of the following AMD genetic subgroup criteria, as reviewed and confirmed by the Sponsor, and be allocated to one of the following groups below:
- •In Stage 1:
- •- Group 1: Subjects carrying a CFI rare variant genotype (minor allele frequency =1%) previously associated with normal serum CFI or subjects carrying an unreported CFI rare variant genotype that have tested to have normal serum CFI.
- •-Group 2: Complement rare: Rare coding variant in either C3, CFB, CFH, CD59, or CD46 genes with a minor allele frequency =2% that is enriched in AMD
- •and/or predicted to be damaging in silico
- •- Group 3: CFH common: Carriers of one or two copies of either the C allele of rs1329428, or the C allele of rs1061170 (also excluding carriers of T allele of rs10033900, which define the CFI common group)
- •- Group 4: CFI common: Carriers of one or two copies of the T allele of rs10033900
- •b. In Stage 2: Genotyping is not required for study eligibility
- •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 or provide documentation of being surgically sterilised. 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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 167
排除标准
- •1. Any carriers of the following genetic variants:
- •a. In Stage 1: ABCA4 rare (minor allele frequency =1%) coding variants predicted to be damaging in silico, either biallelic, or monoallelic in combination with a minor allele of a hypomorphic variant (rs1801466 or rs6657239)
- •b. In Stage 2, subjects are excluded if they have a clinical diagnosis of
- •Stargardt Disease or other retinal dystrophies, as 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 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, uncontrolled intraocular pressure (IOP), despite the use of two or more topical agents; a history of glaucoma-filtering or valve surgery is also excluded
- •8. Axial myopia of greater than -8 diopters in the study eye
- •9. Have received any investigational product 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 formula
- •10. Have received a gene or cell therapy at any time
- •11. Have a contraindication to the protocol specified corticosteroid regimen
- •12. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
- •13. 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
- •14. 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
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