Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole
NCT ID: NCT01429441
Last Updated: 2016-03-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2011-10-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ocriplasmin
Ocriplasmin
0.125 mg single intravitreal injection
Sham injection
Sham injection
Sham injection
Interventions
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Ocriplasmin
0.125 mg single intravitreal injection
Sham injection
Sham injection
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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ThromboGenics
INDUSTRY
Responsible Party
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Locations
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Retinal Consultants of Arizona
Phoenix, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retina Consultants Medical Group
Sacramento, California, United States
West Coast Retina Group, Inc
San Francisco, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
MedEye Associates
Miami, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Associated Retinal Consultants
Royal Oak, Michigan, United States
Sabates Eye Center Research
Kansas City, Missouri, United States
Eyesite Opthalmic Services, PA
Portsmouth, New Hampshire, United States
Retina-Vitreous Center, PA
New Brunswick, New Jersey, United States
Retina Association of NJ
Teaneck, New Jersey, United States
Retina Vitrous Surgeons of CNY
Syracuse, New York, United States
Southeast Clinical Research, PA
Charlotte, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
Mid Atlantic Retina
Huntingdon Valley, Pennsylvania, United States
Texas Retina Associates
Arlington, Texas, United States
Retina Research Center
Austin, Texas, United States
Texas Retina Associates
Dallas, Texas, United States
Retina Consultants, PA
Fort Worth, Texas, United States
Vitroretinal Consultants
Houston, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
Retina Consultants of San Antonio
San Antonio, Texas, United States
Eye Care Associate
Tyler, Texas, United States
Countries
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References
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Velaga SB, Nittala MG, Ip MS, Duchateau L, Sadda SR. Post hoc analysis of ellipsoid zone changes beyond the central subfield in symptomatic vitreomacular adhesion patients from the OASIS trial. BMJ Open Ophthalmol. 2021 Jun 21;6(1):e000648. doi: 10.1136/bmjophth-2020-000648. eCollection 2021.
Yu TM, Dugel PU, Haller JA, Kaiser PK, Arnold RJ. Budget impact analysis of ocriplasmin for the treatment of symptomatic vitreomacular adhesion in the USA. J Comp Eff Res. 2018 Dec;7(12):1195-1207. doi: 10.2217/cer-2018-0057. Epub 2018 Oct 23.
Other Identifiers
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TG-MV-014
Identifier Type: -
Identifier Source: org_study_id
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