NCT04782128进行中（未招募）2 期
A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
研究概览
简要总结
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
- •Aged 18 years to 80 years, male or female;
- •Diabetes mellitus(type 1 or 2);
- •Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
- •BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
- •If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;
排除标准
- •Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
- •Evidence of retinal neovascularization on clinical examination or FA;
- •Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
- •Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
- •History of vitreoretinal surgery in the study eye;
- •Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
- •Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
- •Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day
- •Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
- •Pregnant or lactating women, subjects who had family planning throughout the study period;
- •Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
- •Those who considered unsuitable for enrollment by investigator.
结局指标
主要结局
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
时间窗: At Week 24, 52
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline
次要结局
- Percentage of participants who undergoing Vitrectomy at Week24, 52;(At Week 24, 52)
- Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;(At Week 24, 52)
- Mean change from baseline in DRSS score;(Baseline upto week 52)
- Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;(At Week 24, 52)
- Frequency of administration RC28-E;(At Week 24, 52)
- Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52(At Week 24, 52)
- Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);(Baseline up to week 52)
- Safety of RC28-E injection(Baseline upto week 52)
研究者
研究点 (1)
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