NCT04922151Unknown2 期
A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Pathological Myopic Choroidal Neovascularization (pmCNV)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in best-corrected visual acuity (BCVA) at Week 12
研究概览
简要总结
To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to pmCNV
详细描述
Following a 14-day maximum screening period, patients will be randomized and followed for approximately 36 weeks. Treatment visits will be scheduled in 4-week intervals. After 1 initial injection of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 4 to week 32). During the IFT phase, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 36 weeks unless the patient is withdrawn or discontinues the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Sign informed consent form and willing to be visited at the time specified in the trial
- •Male or Female, at least 18 years of age
- •The study eye must meet the following criteria
- •Diagnosed with active choroidal neovascularization secondary to pathological myopia
- •BCVA score between 78 and 24 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/320)
- •No optometric media opacity and pupil abnormal
- •BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)
排除标准
- •CNV secondary to other causes (except pathological myopia), such as neovascularage-related macular degeneration (nAMD), polypoid choroidal vascular disease (PCV), and secondary injury
- •The fovea has fibrosis and organochemical foci or scar or atrophy that obviously involves the fovea and causes irreversible vision loss;
- •Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to enrollment;
- •PDT, Macular laser photocoagulation (focal/grid), vitrectomy or keratoplasty in the study eye at any time prior to baseline. Panretinal laser photocoagulation，YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline
- •Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery)
- •For Any Eye:
- •Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis)
- •History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab，bevacizumab，aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline
- •General Exclusion Criteria:
- •History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis
- •History of stroke (cerebrovascular accident), myocardial infarction, active disseminated intravascular coagulation or pronounced bleeding tendency in the past 6 months prior to baseline
- •Diagnosed systemic immune diseases (e.g. ankylosing spondylitis, systemic lupus erythematosus, Behcet's disease, rheumatoid arthritis, scleroderma etc.)
- •any uncontrolled clinical problem (e.g. AIDS, active hepatitis, serious mental, neurological, cardiovascular, respiratory and other systemic diseases or malignant tumors, etc.). Malignant tumors with no metastasis or recurrence within 5 years or cancers in situ cancers are not excluded.
- •History of system use of anti-VEGF drugs (e.g. bevacizumab) within 3 months prior to baseline
- •Laboratory Exclusion Criteria:
- •Liver dysfunction (ALT or AST is 2 times higher than the upper limit of normal value in the local laboratory). Renal function impairment (Cr is 1.5 times higher than the upper limit of normal values in the local laboratory)
- •Abnormal coagulation function (prothrombin time >= the upper limit of normal value for 3 seconds) and activated partial thromboplastin time >= the upper limit of normal value for 10 seconds);
- •Other Exclusion Criteria:
- •Non-use of effective contraception during childbearing age (except for women with spontaneous admonishment of more than 12 months)
- •Pregnancy and lactation women
研究组 & 干预措施
group I
Experimental
601 1.25mg
干预措施: 601 (Drug)
group II
Active Comparator
Ranibizuman 0.5 mg
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Change from baseline in best-corrected visual acuity (BCVA) at Week 12
时间窗: Baseline to Week 12
Assessed with ETDRS visual acuity testing charts.
次要结局
- Proportion of study eyes with a gain ≥ 5, 10 and 15 letters in BCVA on each visit compared to baseline(Baseline to Week 36)
- Average Change of BCVA on each visit compared to baseline.(Baseline to Week 36)
- Change from baseline in central retina thickness (CRT) on each visit(Baseline to Week 36)
- Blood concentrations of 601(Baseline, Week 4, Week 12, Week 24 and Week 36.)
- Blood concentrations of VEGF(Baseline, Week 4, Week 12, Week 24 and Week 36.)
- Number of injections from Week 4 to Week 36(Week 4 to Week 36)
- Immunogenicity of 601(Baseline, Week 4, Week 12, Week 24 and Week 36.)
- Incidence of ocular and non-ocular AEs up to Week 36(Baseline to Week 36)
研究者
研究点 (1)
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