Assessment of Anatomical and Functional Outcomes in Patients Treated with Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion (VMT/sVMA) - Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion

Alcon Research, Ltd.0 个研究点目标入组 474 人开始时间: 2015年6月16日最近更新: 2015年11月16日

研究概览

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•- Ages Eligible for Study: 18 Years and older
•- Genders Eligible for Study: Both
•- Diagnosis of vitreomacular traction/symptomatic vitreomacular adhesion (VMT/sVMA), with evidence of focal VMT visible on Spectral Domain Optical
•Coherence Tomography (SD-OCT).
•- Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
•- Other protocol-defined 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 142
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 332

•- Women of childbearing potential if pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
•- Hypersensitivity to ocriplasmin or any of the Jetrea excipients
•- Active or suspected intraocular or periocular infection
•- Presence of Epiretinal Membrane (ERM) over the macula at baseline
•- Broad VMT/VMA >1500 microns at Baseline
•- History of vitrectomy in the study eye
•- History of laser photocoagulation to the macula in the study eye
•- 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
•- Macular hole of >400µm diameter in the study eye
•- High myopia in study eye
•- Pseudo-exfoliation, Marfan’s syndrome, phacodonesis or any other finding in the Investigator’s opinion suggesting lens/zonular instability.
•- Therapy with another investigational agent within 30 days prior to Visit 1.
•- Active, simultaneous enrollment in another ophthalmology clinical study.
•- Other protocol-defined exclusion criteria may apply

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