Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
NCT ID: NCT00913744
Last Updated: 2014-12-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2010-01-31
2013-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ocriplasmin
Ocriplasmin
ocriplasmin intravitreal injection (125 µg)
Sham injection
Sham injection
Sham injection
Interventions
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Ocriplasmin
ocriplasmin intravitreal injection (125 µg)
Sham injection
Sham injection
Eligibility Criteria
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Inclusion Criteria
2. Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
3. Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component.
4. The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be \> 50% of the total lesion area
5. The total lesion area must be \< 12 disc areas
6. Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
7. Subjects with visual acuity of 20/32 to 20/200 in the study eye
8. Written informed consent obtained from the subject prior to inclusion in the study
Exclusion Criteria
2. Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus.
3. Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
4. Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
5. Subjects with high myopia (\> 8D) or aphakia in the study eye
6. Subjects who have had ocular surgery in the study eye in the prior three months
7. Subjects who have had a vitrectomy in the study eye at any time.
50 Years
ALL
No
Sponsors
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ThromboGenics
INDUSTRY
Responsible Party
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Locations
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Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Center for Retina and Maculla Disease
Winter Haven, Florida, United States
Southeast Retina Center, PC
Augusta, Georgia, United States
VitreoRetinal Surgery, PA
Minneapolis, Minnesota, United States
Retina-Vitreous Center, PA
New Brunswick, New Jersey, United States
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates
Kingsport, Tennessee, United States
Retinal Consultants of Houston,
Houston, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
U.Z. Leuven St. Rafaël Hospital
Leuven, , Belgium
Rabelais Ophthalmologic Center
Lyon, , France
Centre Paradis-Monticelli
Marseille, , France
Centre Ophtalmologique d'Imagerie et de Laser
Paris, , France
Centre Ophtalmologique de L'Odeon
Paris, , France
Universität Bonn Augenklinik
Bonn, , Germany
Universität Lübeck Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
Marburg, , Germany
Augenklinik der Ludwig Maximilians Universität München
München, , Germany
University of Milan Department of Clinical Science "Luigi Sacco"
Milan, , Italy
Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
Rome, , Italy
Frimley Park Hospital
Frimley, Camberley, United Kingdom
Royal Liverpool & Broadgreen Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Wolverhampton Eye Infirmary New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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TG-MV-005
Identifier Type: -
Identifier Source: org_study_id