EUCTR2017-003712-39-GB进行中（未招募）1 期
FOCUS: An open label first in human Phase I/II multicentre study to evaluate the safety, dose response and efficacy of GT005 administered as a single subretinal injection in subjects with Macular Atrophy due to Age-related Macular Degeneration
Gyroscope Therapeutics0 个研究点开始时间: 2017年12月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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 consent to the study participation
- •2. Presence of Bilateral GA due to AMD on Colour Fundus Photography
- •3. Cohorts 1 to 3: GA lesions total size in the treatment eye must be =
- •1.25mm2 and =17.5mm2
- •Cohort 4 : GA lesions total size must be =1.25mm2 and =17.5mm2 for both eyes.
- •4. Cohort 1 to 3: The GA lesion in the treatment eye must reside
- •completely within the FAF fundus image
- •Cohort 4: The GA lesion must reside completely within the FAF fundus
- •image for both eyes
- •5. Cohorts 1 to 3: BCVA of =50 letters (6/36 Snellen acuity equivalent or
- •worse) using ETDRS charts in the treatment eye
- •Cohort 4: BCVA of =34 letters (6/60 Snellen acuity equivalent or better)
- •using ETDRS charts in both eyes.
- •6. Aged =55 years
- •7. Able to attend all study visits and complete the study procedures
- •8. Women of child-bearing potential need to have a negative urine
- •pregnancy test within one month prior to receiving the drug
- •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 32
排除标准
- •1. Have evidence or history of CNV in either eye
- •2. Presence of moderate/severe or worse non-proliferative, diabetic retinopathy in either eye
- •3. Have history of vitrectomy, sub-macular surgery, or macular photocoagulation in either eye
- •4. 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
- •5. Have clinically significant cataract that may require surgery during the study period in either eye
- •6. Presence of moderate to severe glaucomatous optic neuropathy in either eye, uncontrolled IOP despite the use of more than two topical agents; a history of glaucoma-filtering or valve is also excluded
- •7. Axial myopia of greater than -8 diopters in the either 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 (AREDS) formula
- •9. Have received a gene or cell therapy at any time
- •10. Have a contraindication to the specified protocol 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
- •11. Have a history or presence of cutaneous squamous cell carcinoma
- •12. 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.
- •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
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