EUCTR2014-001351-23-HU进行中（未招募）1 期
A phase IIa, randomized, placebo-controlled, double-blind, parallel study to investigate the efficacy of EG-Mirotin subcutaneously administered in multiple doses on diabetic macular edema in diabetic retinopathy patients.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- EyeGene, Inc
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Male/female patient, aged between 18 and 75 years inclusive.
- •2. Females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices, diaphragm or condoms) for the duration of the trial and for 4 months after the last study drug administration. For sexually active male subjects with partners of childbearing potential: accepting to use effective methods of contraception during the study and for 16 weeks after the last drug intake.
- •3. Females of non-childbearing potential: females must be either surgically sterilized or at least 1 year postmenopausal (amenorrhoea duration at least 12 months).To be eligible for entry into the study, females must have a negative pregnancy test at screening baseline.
- •4. Patient with type 2 diabetes mellitus with Hb1Ac (glycosylated haemoglobin) = 10%.
- •5. Body Mass Index (BMI) between 22 and 32 kg/m2 inclusive.
- •6. Normal blood pressure (BP) and heart rate (HR) at the screening visit after 10 minutes in supine position:
- •95 mmHg = SBP (systolic blood pressure) = 160 mmHg,
- •50 mmHg = DBP (diastolic blood pressure) = 95 mmHg,
- •7. Normal electrocardiogram (ECG) recording on a 12-lead ECG or considered NCs by investigators:
- •8. Laboratory parameters within the normal range of the laboratory (hematological, blood chemistry tests, urinalysis). Individual values out of the normal range can be accepted if judged clinically non relevant by the Investigator.
- •9. Having given a written informed consent prior to selection.
- •10. Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.
- •11. Stable antidiabetic treatment for 3 months and for the next 4 months: if needed: metformin and other oral antidiabetics, antihypertensive and drugs to treat dyslipidemiea are allowed.
- •Ocular within 21 days of randomization :
- •At least one eye meets the study eye criteria listed below :
- •12. Best-corrected ETDRS visual acuity letter score between = 79 (approximate Snellen equivalent 20/30 or better) and 24 (approximately 20/320),
- •13. Non proliferative retinopathy or inactive proliferative retinopathy treated by panretinal photocoagulation dating more than 6 months
- •14. CSF- thickness measured on spectral domain optical coherence tomography (SD-OCT) of = 305µm in women, and = 320µm in men in the central subfield (average of 2 measurements),
- •15. Assessment by the treating ophthalmologist that focal photocoagulation (in the study eye) and/or anti-VEGF treatment (in both eyes) could be deferred safely for 4 months
- •16. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus imaging;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Presence or history of protein drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- •2. Allergy to fluorescein
- •3. Patients who are pregnant or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the time of study participation.
- •4. Any drug intake during the last month prior to the first administration except those defined in Section 5.3.
- •5. Use of anti-platelets drugs
- •6. Intensive insulin treatment (a pump or more than 3 daily injections)
- •7. Edema is considered to be due to a cause other than diabetic edema for the chosen eye, especially vitreoretinal interface abnormalities within 1 disc diameter of the fovea (e.g., a taut posterior hyaloid or epiretinal membrane).
- •8. An ocular condition is present resulting visual acuity would not improve from resolution of edema, at the discretion of the investigator (e.g. foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition) for the chosen eye.
- •9. An ocular condition is present (others than diabetes) that, in the opinion of the investigator, might affect edema or alter visual acuity during the course of the study (e.g. vein occlusion, uveitis, or other ocular inflammatory disease, neovascular glaucoma…).
- •10. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines (i.e. cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal) for the chosen eye.
- •11. Prior history of intravitreal or peribulbar injections of triamcinolone acetonide or vitrectomy, intravitreal injection of anti-VEGF treatment within the prior 4 months,
- •12. Prior history of yttrium–aluminum–garnet capsulotomy within the prior 2 months.
- •13. History of major ocular surgery (cataract or glaucoma surgery, pars plana vitrectomy) in the study eye within prior 4 months or anticipated within the next 4 months following randomization.
- •14. Prior focal photocoagulation within 4 months before administration
- •15. Prior panretinal scatter photocoagulation within 6 months before administration or need for a panretinal scatter photocoagulation within the next 4 months (severe pre proliferative diabetic retinopathy or proliferative diabetic retinopathy)
- •16. Active neovascularization of the disc, retina, iris, or angle, vitreous haemorrhage or tractional retinal detachment for the chosen eye
- •17. Macular ischemia (>grade 2) on fluorescein angiography
- •18. General anesthesia within 3 months before administration.
- •19. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
- •20. Positive HBs antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.
- •21. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant, calculated creatinine clearance = 60 mL/min.
- •22. Blood donation (including in the frame of a clinical trial) within 2 months before administration.
- •23. Patient who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a
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