NL-OMON40974已完成4 期
Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for VMT/sVMA
Alcon Laboratories0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. At least 18 years age of at the time of informed consent
- •2. Diagnosed with VMT/sVMA, with evidence of focal VMT visible on SD-OCT.
- •3. An Institutional Review Board/Ethics Committee-approved informed consent form must be
- •read, signed, and dated by the participating subject.
排除标准
- •1. Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile) are excluded if:
- •a. they are currently pregnant,
- •b. have a positive result on the urine pregnancy test at Screening,
- •c. intend to become pregnant during the study period,
- •d. they are breastfeeding, or
- •e. are 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
- •4. Presence of Epiretinal Membrane (ERM) over the macula at baseline.
- •5. Broad VMT/VMA >1500 microns at Baseline.
- •6. History of vitrectomy in the study eye.
- •7. History of laser photocoagulation to the macula in the study eye.
- •8. Any relevant concomitant ocular condition that, in the opinion of the investigator, could be
- •expected to worsen or require surgical intervention during the study period.
- •9. Macular hole of >400*m diameter in the study eye.
- •10. High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive
- •surgery that makes refraction assessment unreliable for myopia severity approximation, in
- •which case axial length >28mm is an exclusion)
- •11. Pseudo-exfoliation, Marfan*s syndrome, phacodonesis or any other finding in the
- •Investigator*s opinion suggesting lens/zonular instability.
- •12. Therapy with another investigational agent within 30 days prior to Visit 1.
- •13. Active, simultaneous enrollment in another ophthalmology clinical study.
- •14. Aphakia.
- •15. History of Retinal Detachment.
- •16. Recent ocular surgery or ocular injection within the past 3 months (including laser therapy).
- •17. Proliferative diabetic retinopathy.
- •18. Ischaemic retinopathies
- •19. Retinal vein occlusions.
- •20. Exudative age-related macular degeneration (AMD).
- •21. Vitreous hemorrhage.
研究者
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