NCT06412224招募中早期 1 期
An Exploratory ITT（Investigator Initiated Study) Study to Evaluate the Preliminary Safety and Efficacy of Single Subretinal Injection of RRG001 at the End of or After Vitrectomy in Subjects With PDR
Li Xiaorong1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年12月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
研究概览
简要总结
This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide informed consent
- •Age >= 20 years
- •Diagnosis of diabetes mellitus (type 1 or type 2)
- •The study eye diagnosed with PDR, in the opinion of the investigator, requires vitrectomy and postoperative anti-VEGF therapy, or that has undergone vitrectomy and still requires postoperative anti-VEGF therapy
- •Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters
排除标准
- •Active infection or inflammation in either eye
- •Previous gene therapy in either eye
- •Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
- •HbA1c >12% for diabetes patients at screening
- •Previous condition not eligible for study drug
- •History of major ocular surgery (except for PDR) or severe trauma
- •Currently enrolled in another clinical trial or planning to enroll during the study
- •Pregnant or lactating women
- •Other conditions that, in the opinion of the investigator, would preclude participation in the study
- •Study Eye-Exclusion Criteria：
- •Ocular disorders that, in the opinion of the investigator, would confound the interpretation of study results or affect the administration
- •CNV or macular edema secondary to any causes other than diabetic retinopathy
- •Ocular condition considered by the investigator to contraindicate subretinal injection
- •Diagnosed primary or secondary glaucoma
- •History of intraocular corticosteroid treatment
研究组 & 干预措施
RRG001
Experimental
Frequency of administration: one time injection.
干预措施: RRG001 (Drug)
结局指标
主要结局
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
时间窗: Within 28 days after RRG001 administration
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts
时间窗: Within 24 weeks after RRG001 administration
To evaluate the incidence of AEs as assessed CTCAE 5.0 at most 6 subjcts
次要结局
- To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the change from baseline in BCVA(Best Corrected Visual Acuity) of the study eye as assessed by ETDRS chart at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the frequency for rescue therapy of the study eye at most 6 subjects(Within 24 weeks after RRG001 administration)
- To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects(Within 24 weeks after RRG001 administration)
研究者
Li Xiaorong
Assistant Investigator
Tianjin Medical University Eye Hospital
研究点 (1)
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