Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion

Completed · Phase 2 · Has a placebo group

Conditions studied: Exudative Age-Related Macular Degeneration, Focal Vitreomacular Adhesion

In brief

This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).

Key facts

Study ID

NCT00913744

Run by

ThromboGenics

People needed

100

Starts

2010-01-01

Expected to finish

2013-04-01

Last updated by the study team

2014-12-17

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects aged > 50
• Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT).
• 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.
• 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
• The total lesion area must be < 12 disc areas
• Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye.
• Subjects with visual acuity of 20/32 to 20/200 in the study eye
• Written informed consent obtained from the subject prior to inclusion in the study

You may not qualify if…

• Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection
• 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.
• Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye
• Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye
• Subjects with high myopia (> 8D) or aphakia in the study eye
• Subjects who have had ocular surgery in the study eye in the prior three months
• Subjects who have had a vitrectomy in the study eye at any time.

Where it is running

• 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

Full record on ClinicalTrials.gov

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