Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole

Completed · Phase 3 · Has a placebo group

Conditions studied: Vitreomacular Adhesion Including Macular Hole

In brief

The purpose of this study is to evaluate the treatment of symptomatic vitreomacular adhesion / (VMT) including macular hole with ocriplasmin.

Key facts

Study ID

NCT01429441

Run by

ThromboGenics

People needed

220

Starts

2011-10-01

Expected to finish

2014-10-01

Last updated by the study team

2016-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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