NCT03452657Unknown3 期
Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine7 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2018年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 118
- 试验地点
- 7
- 主要终点
- Proportion of eyes with a ≥ 2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR.
详细描述
This study is a randomized, double-blind, multi-center, sham-controlled clinical trial. In this trial, 118 subjects will be enrolled. Subjects with signed informed consent are screened and assigned randomly (1:1) to one of the following parallel groups: Group A-Intravitreous 0.5 mg ranibizumab injections and Group B-sham injections. All participants have visits at 0 month, 1 month, and 2 months, followed by visits every 3 months thereafter through 1 year. The main efficacy and safety outcomes assessment will be finished at the end of 12 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years;
- •Diagnosis of diabetes mellitus (type 1 or type 2);
- •The fundus color photography was graded by Reading Center as grade 47-53;
- •Patients have not received Pan Retinal Photocoagulation (PRP: laser spots on fundus outside hemal arch are less than 100);
- •HbA1C≤ 10%;
- •Media clarity and pupillary dilation sufficient to obtain adequate fundus examinations;
- •No central subfield macular edema.
排除标准
- •Ocular infection, including conjunctivitis, chalazion, or substantial blepharitis;
- •Proliferative diabetic retinopathy;
- •History of prior vitreous hemorrhage within 2 months;
- •An ocular condition is presented (other than DR), (e.g., retinal vein or artery occlusion, CNV, retinal detachment, macular hole, vitreomacular traction, etc.);
- •Evidence of iris neovascularization;
- •Evidence of uncontrolled glaucoma( Intraocular pressure >25 mmHg with glaucoma medication) or history of anti-glaucoma surgery;
- •Server cataract that influences judgment or needs cataract surgery in 6 months;
- •Received other ocular treatment:
- •History of intravitreal injection of corticosteroid within 3 months, or peribulbar injection of corticosteroid within 1 month;
- •History of vitreous surgery;
- •History of PRP ≥ 2 times or within 6 months in the study eye;
- •History of focal laser treatment within 3 months or laser treatment involving fovea ≥ 2 times in the past in the study eye;
- •History of anti-VEGF treatment within 6 months in the study eye or history of anti-VEGF treatment within 3 months in the non-study eye;
- •History of any intraocular surgery within 3 months;
- •History of macular surgery within 3 months;
- •Have any following condition of systemic diseases:
- •Unsatisfactory blood glucose control within 3 months (defined as turn oral antidiabetic drugs into insulin therapy/insulin pump treatment or daily insulin injection times doubled);
- •Impaired renal function (Crea: 2 times higher than the upper limit of the normal laboratory center) or liver dysfunction (ALT, AST: 2 times higher than the upper limit of the normal laboratory center );
- •Poor blood pressure control (defined as systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 95 mmHg under antihypertensive therapy);
- •Any systemic infection that requires oral, intramuscular or intravenous administration ;
- •Stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure occurred within 6 months before the screening;
- •Coagulation dysfunction (prothrombin time ≥ normal upper limit of 3 seconds, activated partial thromboplastin time ≥ normal upper limit of 10 seconds);
- •Drugs that are toxic to the lens, retina, or optic nerve are being used or may be required during the study (such as deferoxamine, chloroquine, hydroxychloroquine, tamoxifen, phenothiazine or ethambutol, etc.);
- •Have a diagnosis of systemic immune diseases (such as ankylosing spondylitis, systemic lupus erythematosus, etc.) or any uncontrollable clinical problems (such as AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, Respiratory and other diseases, etc.);
- •Known allergy to fluorescein dye, or protein products for treatment or diagnosis, or allergies to more than two drugs and / or nonpharmacological factors, or is suffering from allergic diseases;
- •No use of effective contraception; Note: The following conditions are not excluded. I. Amenorrhea 12 months under natural circumstances, or natural amenorrhea for 6 months and serum follicle-stimulating hormone levels <40 mIU / ml; Ii. Bilateral ovariectomy with or without hysterectomy after 6 weeks; Iii. Use of one or more of the following acceptable contraceptive methods: sterilization (male with bilateral vasectomy, resection) , hormone contraceptive (implantable, patch-type, oral) , O IUD, or double barrier method; Iv. Reliable contraceptive measures used throughout the whole study period and adherence to the 30 days of discontinuation of the study drug (unacceptable contraceptive methods: regular abstinence - calendar, ovulation, body temperature, post-ovulation, Row fine);
- •Pregnant (pregnancy in this test is defined as urine pregnancy test positive) or lactating women;
- •Within 3 months (if the test drug has a long half-life and five half-life periods > 3 months, the time is 5 half-life periods) before screening, participated clinical trials of any drug (not including vitamins and minerals);
- •Those that researchers believe need to be excluded.
- •Exit Criteria:
- •During the clinical trial, patients may withdraw from the trial at any time for their own consideration or at the request of the investigator. For each subject who withdrawn from the trial, the investigator must detail the exit date, reasons, and other information in the case report form and original documents.
- •Subjects must withdraw from the study if:
- •Withdrawal of informed consent;
- •Participating in other clinical trials of new drugs during the trial;
- •Pregnancy during the trial;
- •Occurrence of ocular serious adverse events;
- •For safety, the researcher consider that the subject should withdraw from the trial.
- •Subjects may withdraw from the study early because of the following conditions:
- •Lost to follow-up;
- •Compliance issues;
- •Delay of injection more than 30 days for any reason;
- •Retinal laser photocoagulation is required during the trial;
- •Researchers consider that the treatments in this study (including remedial treatment) are no longer suitable for DME therapy in subjects;
- •Occurrence of adverse events or serious adverse events (subjects that need hospitalization or prolongation of hospital stay due to adverse events, without affecting the safety and efficacy evaluation, may not exit);
- •Use of prohibited drugs during the study;
- •Deviation from the research protocol.
研究组 & 干预措施
Ranibizumab
Experimental
Participants received 0.5mg intravitreal ranibizumab injection
干预措施: Ranibizumab (Drug)
Sham-injection
Sham Comparator
No drug involved in the sham procedure; patient's eye is anesthetized and a syringe without needle gently pressed on the conjunctival surface to simulate the force of an actual injection
干预措施: No drug (Procedure)
结局指标
主要结局
Proportion of eyes with a ≥ 2-step improvement in the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score
时间窗: 1 year
Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85)
次要结局
- Change from baseline in CRT (central retinal thickness)(1 year)
- Mean change from baseline in best-corrected visual acuity (BCVA)(1 year)
- Proportion of eyes that meet the protocol-defined failure criteria(1 year)
研究者
Xun Xu
Chief Physician, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (7)
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