Status:
COMPLETED
Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
Lead Sponsor:
ThromboGenics
Conditions:
Vitreomacular Adhesion Including Macular Hole
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.
Detailed Description
The present study is designed to assess anatomical and functional outcomes following a single intravitreal injection of ocriplasmin 0.125mg in subjects with symptomatic vitreomacular adhesion (VMA)/ (...
Eligibility Criteria
Inclusion
- Subjects 18 years of age or older and of either gender
- Presence of vitreomacular adhesion
- Best corrected visual acuity (BCVA) of 20/32 or worse in study eye
- BCVA of 20/800 or better in the non-study eye
Exclusion
- History or current evidence of proliferative retinopathy, exudative age-related macular degeneration (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 spectral-domain optical coherence tomography (SD-OCT) in the study eye
- Macular hole of \> 400 µm diameter in the study eye
- Presence of epiretinal membrane (ERM)
- Aphakia in the study eye
- High myopia (more than 8D) in study eye
- History of rhegmatogenous retinal detachment in either eye
- History of vitrectomy in the study eye
- Previous participation in this trial or prior administration of ocriplasmin in the study eye
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01429441
Start Date
October 1 2011
End Date
October 1 2014
Last Update
March 14 2016
Active Locations (25)
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1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85014
2
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
3
Retina Consultants Medical Group
Sacramento, California, United States, 95819
4
West Coast Retina Group, Inc
San Francisco, California, United States, 94107