EUCTR2020-002431-30-GB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 180 人开始时间: 2020年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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
- •1. Able and willing to give written informed consent
- •2. Age =55 years
- •3. Have a clinical diagnosis of bilateral GA secondary to AMD as determined by the Investigator
- •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. Have a BCVA of =34 letters (6/60 or 20/200 Snellen acuity equivalent), using ETDRS charts, in the study eye
- •7. Meet the following AMD genetic subgroup criteria, as reviewed and confirmed by the Sponsor, and be allocated to one of the following groups below:
- •a. CFI rare variant Type 2: CFI rare variant (minor allele frequency =1%) that has serum Factor I levels in that patient carrier measuring =11.6 µg/ml, and the variant is enriched in AMD and/or predicted to be functionally damaging in silico
- •b. 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
- •c. 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)
- •d. CFI common: Carriers of one or two copies of the T allele of rs10033900
- •8. Able to attend all study visits and complete the study procedures
- •9. Women of child-bearing potential must have a negative pregnancy test within 2 weeks prior to randomisation or provide documentation of being surgically sterilised
- •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. 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. CFI rare variant Type 1 (minor allele frequency =1%) that has been tested to have a low Factor I level in serum of that patient (<11.6 µg/ml),
- •2. Have evidence or history of CNV in either 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. Have clinically significant cataract that may require surgery during the study period in the study eye
- •6. Presence of moderate to severe glaucomatous optic neuropathy, uncontrolled intraocular pressure (IOP), use of two or more topical agents to control IOP, or a history of glaucoma-filtering surgery in the study eye
- •7. Axial myopia of greater than -8 diopters in the study eye
- •8. 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
- •9. Have received a gene or cell therapy at any time
- •10. Have a contraindication to the corticosteroid regimen
- •11. Are unwilling to use two forms of contraception (one of which being a barrier method) for 90 days post-dosing, if relevant
- •12. Have a history or presence of cutaneous squamous cell carcinoma
- •13. 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
研究者
相似试验
进行中（未招募）
1 期
A study to test the safety and effect of a treatment for people with sight loss due to dry Age-related Macular DegeneratioAge-related Macular Degeneration (AMD) presents as a progressive loss of vision in the centre of the retina (the macula) resulting in a blurred area or blank spot in the centre of vision. The primary clinical characteristic of late stage AMD is atrophy of the Retinal Pigment Epithelium, known as macular atrophy due to AMD, which leads to the gradual degeneration of nearby photoreceptors, resulting in thinning of the retina and a progressive visual impairment.MedDRA version: 20.0Level: LLTClassification code 10075719Term: Atrophic age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2020-002431-30-DEGyroscope Therapeutics Ltd.250
进行中（未招募）
1 期
A study to test the safety and effect of a treatment for people with sightloss due to dry Age-related Macular DegeneratioEUCTR2020-002431-30-IEGyroscope Therapeutics250
进行中（未招募）
1 期
A phase II, multicentre, open label, prospective, interventional study to evaluate the sperm DNA fragmentation in idiopathic male infertility before and after treatment with Gonal-f PEN 900 IU. - NDIdiophatic male infertilityMedDRA version: 9.1Level: SOCClassification code 10014698EUCTR2010-020196-23-ITMERCK SERONO SPA
招募中
2 期
A Phase II, prospective, open-label, dual-centre, single-arm feasibility study of Pregabalin for the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed.ACTRN12621001626853niversity of Technology Sydney24
进行中（未招募）
不适用
A phase II, open-label, prospective, multicenter study to evaluate theefficacy and safety of subsequent treatment with the Zevalin(ibritumomab tiuxetan) study in patients with follicular grade I-IIlymphoma after 4 cycles of Fludarabine-Mitoxantrone-Rituximab(FMR) therapy. - NDEUCTR2006-004850-26-ITAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI