NCT06302608进行中（未招募）1 期
Clinical Trial on the Safety and Effectiveness of Subretinal Injection of NGGT001 for Treating Crystalline Retinal Degeneration
Xiamen Ophthalmology Center Affiliated to Xiamen University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年2月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
Evaluate the safety and tolerability of NGGT001 subretinal injection for the treatment of crystalline retinal degeneration (BCD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old;
- •Gender unlimited.
- •Diagnosed as crystalline retinal degeneration (BCD).
- •Molecular diagnosis confirms CYP4V2 mutation.
- •The best corrected visual acuity is less than 20/
- •Agree to take contraceptive measures within 1 year from the start of the study until administration.
- •Voluntarily sign an informed consent form.
排除标准
- •Insufficient number of photoreceptor cells in the retina, such as retinal thickness less than 100 μ m. Or no atrophy or pigmentation in the posterior pole area<3- Retinal disc.
- •The presence of choroidal neovascularization or other eye lesions caused by BCD, which researchers believe may affect surgical procedures or interfere with the interpretation of clinical endpoints.
- •The use of therapeutic drugs within the first 6 months of enrollment may affect experimental observation, such as Lucentis, Avastin, Conbercept, Triamcinolone acetonide, steroids, etc;
- •The treatment eye has undergone intraocular surgery, such as PDT, vitrectomy, periocular vascular bypass surgery, etc., or requires intraocular surgery during clinical research, such as cataract surgery, retinal laser therapy, etc;
- •Used or may use systemic medications that may cause eye damage, such as psoralen, tamoxifen, etc;
- •Highly sensitive or allergic to the ingredients in the experimental drug (with a history of allergies to two or more drugs or foods);
- •Abnormal and clinically significant physical examination, vital signs, laboratory tests (such as blood routine, urine routine, blood biochemistry, coagulation function, immunological tests, etc.), or abnormal indicators deemed clinically significant by researchers;
- •There are diseases or medical histories that may affect drug safety or internal processes, especially cardiovascular, liver, kidney, endocrine, digestive, lung, neurological, hematological, tumor, immune or metabolic disorders that researchers consider clinically significant.
- •Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment;
- •Female patients during pregnancy or lactation;
- •Other researchers believe that it is not suitable to participate in the study.
研究组 & 干预措施
Dose Level 4
Experimental
Dose level 4 will be administered
干预措施: NGGT001 (Genetic)
Dose Level 3
Experimental
Dose level 3 will be administered
干预措施: NGGT001 (Genetic)
Dose level 2
Experimental
Dose level 2 will be administered
干预措施: NGGT001 (Genetic)
Dose level 1
Experimental
Dose level 1 will be administered
干预措施: NGGT001 (Genetic)
结局指标
主要结局
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: 1 year
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
BCVA
时间窗: 1 year
ETDRS visual acuity
次要结局
- Change from baseline in best-corrected visual acuity(Baseline and Months 1, 2, 3, 4, 5, 6, 9, and 12; the primary efficacy assessment is the change from baseline at Month 12.)
- Change from baseline in retinal sensitivity assessed by microperimetry(Baseline to Month 12)
- Change from baseline in contrast sensitivity(From baseline at Month 12)
研究者
研究点 (1)
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