EUCTR2017-003234-82-GB进行中（未招募）1 期
A Phase III Multicenter Randomized, Sham Controlled,Study to Determine the Safety and Efficacy ofRenexus® in Macular Telangiectasia type 2 - NTMT-03-A
eurotech Pharmaceuticals0 个研究点目标入组 112 人开始时间: 2017年10月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- 性别
- All
入选标准
- •To participate in this study, the potential participant and at least 1 of their eyes must meet all of the following criteria:
- •1. Participant must have at least 1 study eye with a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500 micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities
- •2. Participant must have an IS/OS PR break and EZ (area of IS/OS loss) as measured by SD OCT between 0.16 and 2.00 mm2
- •3. Participant’s best-corrected visual acuity (BCVA) is 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening
- •4. Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs
- •5. Participant must be greater than 21 years of age or less than 80 years of age at screening
- •6. Participant must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practices guidelines, and local regulations, before initiating any study related procedures
- •7. Women of childbearing potential must agree to use highly effective contraception (Germany and France only)
- •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 112
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •To participate in this study, the potential participant must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):
- •1. Participant is medically unable to comply with study procedures or follow-up visits
- •2. Participant received intravitreal steroid therapy for non neovascular MacTel within the last 3 months
- •3. Participant has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye OR has, within the past 3 months, received intravitreal anti VEGF therapy in the fellow eye at randomization
- •4. Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (eg, glaucoma, severe nonproliferative or proliferative diabetic retinopathy, uveitis)
- •5. Participant has a chronic requirement (eg, = 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted)
- •6. Participant has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye
- •7. Participant has evidence of central serous chorio-retinopathy in either eye
- •8. Participant has evidence of pathologic myopia in either eye
- •9. Participant has significant corneal or media opacities in either eye
- •10. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty
- •11. Participant has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age Related Eye Disease Study (AREDS) clinical lens grading system
- •12. Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks
- •13. Participant was a participant in any other clinical trial of an intervention (drug or device) within the last 6 months
- •14. Participant is on chemotherapy
- •15. Participant is pregnant or breastfeeding
- •16. Participant has a history of malignancy that would compromise the 24-month study survival
- •17. Participant with a history of ocular herpes virus in either eye
- •18. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments
- •19. Participant has evidence of intraretinal hyperreflectivity by OCT
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