EUCTR2014-004778-41-GR进行中（未招募）不适用
Assessment of Anatomical and Functional Outcomes in Subjects Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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
- •1. Ages Eligible for study: 18 years and older
- •2. Diagnosed with VMT/sVMA, with evidence of focal VMT visible on Spectral Domain – Optical Coherence Tomography (SD-OCT)
- •3. Read, signed, and date an Institutional Review board/Ethics Committeeapproved informed consent form
- •4. Willing and able to attend all study visits
- •5. Other protocol-specified inclusion criteria may apply
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 330
排除标准
- •1. Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study
- •2. Hypersensitivity to ocriplasmin or any of the JETREA excipients
- •3. Active or suspected intraocular or periocular infection in either eye
- •4. Participation in any interventional clinical trial within 30 days prior to baseline
- •5. Presence of epiretinal membrane (ERM) over the central macula in the study eye
- •6. Broad VMT/sVMA > 1500 microns in the study eye
- •7. History of vitrectomy in the study eye
- •8. History of laser photocoagulation to the macula in the study eye
- •9. Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period
- •10. Macular hole of > 400 microns diameter in the study eye
- •11. High myopia in the study eye
- •12. Pseudo-exfoliation, Marfan’s syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator’s opinion suggesting lens/zonular instability
- •13. Aphakia in the study eye
- •14. History of retinal detachment in the study eye
- •15. Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy)
- •16. Proliferative diabetic retinopathy in the study eye
- •17. Ischemic retinopathies in the study eye
- •18. Retinal vein occlusions in the study eye
- •19. Exudative age-related macular degeneration (AMD) in the study eye
- •20. Vitreous hemorrhage in the study eye
- •21. Other protocol-specified exclusion criteria may apply
研究者
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已完成
4 期
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