Study Detail: Treatment of Symptomatic Adhesion
Trial Description Summary
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion including macular hole with ocriplasmin.
Basic Trial Information
Phase: II
Disease Status: Symptomatic vitreomacular adhesion
Age: 18 or older
Sponsor: Thrombogenics
Protocol #: TG-MV-014
Status: Enrollment to start November 2011
Study Duration: 1 year
Eligibility Criteria
Inclusion Criteria
OPHTHALMIC INCLUSION
• Subjects 18 years of age or older and of either gender
• Presence of Vitreomacular adhesion (i.e., central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
• BCVA of 20/32 or worse in study eye
• BCVA of 20/800 or better in the non-study eye
Exclusion Criteria
STUDY EYE INCLUSION
• History or current evidence of proliferative retinopathy (including PDR or other ischemic retinopathies involving vitreoretinal vascular proliferation), Exudative AMD or retinal vein occlusion in the study eye
• Any vitreous hemorrhage or any other vitreous opacification which precludes the visualization of the posterior pole by visual inspection OR adequate assessment of the macula by SD-OCT in the study eye
• Macular hole of > 400 μm diameter in the study eye
• ERM
• Aphakia in the study eye
• 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 >28 mm is an exclusion)
• History of rhegmatogenous retinal detachment in either eye
• Intraocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye within three months prior to enrolment
• History of laser photocoagulation to the macula in the study eye
• History of PPV in the study eye
Other inclusion/exclusion criteria per protocol to be screened by the Clinical Coordinator
Study Title
A Randomized, Sham-Controlled, Double-Masked, Multicenter Study Evaluating Ocriplasmin Treatment for Symptomatic Vitreomacular Adhsion including Macular Holes (OASIS)
Trial Contact Information
Site: Study Coordinator Susan Rath
216/831-5704 ext. 253