NCT05099094进行中（未招募）早期 1 期
A Safety and Efficacy Study of VEGFA-targeting Gene Therapy to Treat Refractory Retinal and Choroidal Neovascularization Diseases
Shanghai BDgene Co., Ltd.1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年11月25日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events
研究概览
简要总结
Patients who respond to anti-VEGF therapy but with refractory retinal and choroidal neovascularization diseases including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion-Macular edema (RVO-ME).
详细描述
Choroidal and retinal angiogenesis diseases are a group of diseases characterized by choroidal or retinal angiogenesis. These diseases are often correlated with the macular area, which may lead to significant visual loss. In this study, The IDLV vector is engineered to carry the VEGFA antibody gene. The gene is delivered to the RPE cells to express the VEGFA antibody which neutralizes the VEGFA activity in the posterior segment of the eye of individuals who have progressed to various forms of neovascular macular degeneration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nAMD at the age ≥50; Or patients with diabetic macular edema (DME) at the age ≥18; Or patients with macular edema following retinal vein occlusion (RVO-ME) at the age ≥
- •Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity ≤63 and letter score ≥19 Corresponding Snellen vision ≤20/63 and ≥20/400).
- •OCT confirms the presence of intraretinal fluid or subretinal fluid in the fovea.
- •Have received anti-VEGF therapy in the past and have responded to anti-VEGF therapy.
- •With refractory conditions: repeated anti-VEGF treatments are required due to the disease condition. When the treatment is interrupted, the disease condition recurs (OCT examination indicates increased subretinal/inner effusion in the macula)
- •For patients with both eyes suffered, enroll the one with more severe condition.
- •Routine blood test, liver and kidney function, coagulation index of patients is normal：AST/ALT < 2.5 × ULN; TB < 1.5 × ULN; PT < 1.5 × ULN; Hb > 10 g/dL (male) and > 9 g/dL (female); PLT > 100 × 10^3/µL; eGFR > 30 mL/min/1.73 m^
- •Subjects voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
排除标准
- •Choroidal neovascularization or macular edema induced by other diseases.
- •Any other factors that affect vision improvement in the study eye, such as fibrosis, atrophy, or RPE tear in the fovea of the macula.
- •The study eye already has severe proliferative retinopathy, such as retinal neovascularization, traction retinal detachment, etc. (only for DME and RVO-ME patients) .
- •Retinal detachment or advanced glaucoma in the study eye.
- •Implants in the study eye (except intraocular lenses).
- •Received internal eye surgery within 3 months prior to enrollment.
- •Vitrectomy surgery on the study eye.
- •Received intravitreal glucocorticoid or other clinical research drugs (except anti-VEGF therapy) within 6 months prior to enrollment.
- •Myocardial infarction, cerebrovascular accident or transient ischemic attack occurred within 6 months prior to enrollment.
- •Poorly controlled hypertension under maximum medication (systolic blood pressure>180 mmHg, diastolic blood pressure>100 mmHg).
- •Poor blood glucose control under medication (fasting blood glucose is greater than or equal to 10.0 umol/L).
- •Women who are willing to give birth; pregnant/breastfeeding women Have received gene therapy in the past.
结局指标
主要结局
Treatment-related adverse events
时间窗: At multiple timepoints after infusion up to 12 months.
Observe and record incidences of AE and SAE related to VEGFA-targeting gene therapy drug BD311 (IDLV expressing VEGFA antibody) administration.
次要结局
- Change in central retinal thickness (CRT)(At multiple timepoints after infusion up to 12 months.)
- Changes in the area of choroidal neovascularization(At multiple timepoints after infusion up to 12 months.)
- The number of rescue treatments(At multiple timepoints after infusion up to 12 months.)
- Changes in the area of fluorescein leakage(At multiple timepoints after infusion up to 12 months.)
- Changes in macular intraretinal fluid (IRF)(At multiple timepoints after infusion up to 12 months.)
- Changes in subretinal fluid (SRF)(At multiple timepoints after infusion up to 12 months.)
- Evaluate the visual improvement(At multiple timepoints after infusion up to 12 months.)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular DiseasesPolypoidal Choroidal VasculopathyConberceptPharmacogenomicPathological MyopiaAge-Related Macular DegenerationNCT03128463Xun Xu5,000
Unknown
4 期
Genetics in Non-response to Anti-VEGF Treatment in Exudative AMDMacular DegenerationNCT01213667University of Cologne110
已完成
4 期
Early anti-VEGF Therapy Intervention for Retinal Vein OcclusioRetinal vein occlusionJPRN-UMIN000026173Kyoto Prefectural Univerisity of Medicine50
已完成
不适用
A Retrospective Study of Anti-Vascular Endothelial Growth Factor (VEGF) Injections for Retinal Vein Occlusion or Diabetic Macular EdemaMacular EdemaRetinal Vein OcclusionNCT01918371Allergan323
招募中
不适用
The effect of anti-VEGF treatments for neovascular,exudative and inflammatory ocular diseasesOcular diseases including neovascular, serous and inflammatory diseasesJPRN-UMIN000021589The department of ophthalmology,Tohoku university graduate School of Medicine3,000