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

Phase 2

Completed

• Conditions: Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion
• Interventions: Drug: Sham injection; Drug: Ocriplasmin

• Registration Number: NCT00913744
• Lead Sponsor: ThromboGenics

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Study Start: 2010-01
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Status Verified: 2014-04
• Results First Submitted: 2014-04-02
• Results First Submitted QC: 2014-04-02
• Results First Posted: 2014-05-05
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Male or female subjects aged > 50
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

1. 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
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham injection	Sham injection	-
Ocriplasmin	Ocriplasmin	-

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28	Day 28	The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation

Trial Locations

Locations (27)

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Retinal Consultants of Houston,; 🇺🇸 Houston,, Texas, United States

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

Southeastern Retina Associates; 🇺🇸 Kingsport, Tennessee, United States

U.Z. Leuven St. Rafaël Hospital; 🇧🇪 Leuven, Belgium

Retina-Vitreous Center, PA; 🇺🇸 New Brunswick, New Jersey, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology; 🇮🇹 Rome, Italy

Royal Liverpool & Broadgreen Hospital; 🇬🇧 Liverpool, United Kingdom

Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg; 🇩🇪 Marburg, Germany

Rabelais Ophthalmologic Center; 🇫🇷 Lyon, France

Universität Lübeck Universitätsklinikum Schleswig-Holstein; 🇩🇪 Lübeck, Germany

Valley Retina Institute; 🇺🇸 McAllen, Texas, United States

Frimley Park Hospital; 🇬🇧 Frimley, Camberley, United Kingdom

Center for Retina and Maculla Disease; 🇺🇸 Winter Haven, Florida, United States

Centre Ophtalmologique d'Imagerie et de Laser; 🇫🇷 Paris, France

Centre Paradis-Monticelli; 🇫🇷 Marseilles, France

Retinal Consultants Medical Group; 🇺🇸 Sacramento, California, United States

Centre Ophtalmologique de L'Odeon; 🇫🇷 Paris, France

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States

Southeast Retina Center, PC; 🇺🇸 Augusta, Georgia, United States

Wolverhampton Eye Infirmary New Cross Hospital; 🇬🇧 Wolverhampton, United Kingdom

University of Milan Department of Clinical Science "Luigi Sacco"; 🇮🇹 Milan, Italy

Universität Bonn Augenklinik; 🇩🇪 Bonn, Germany

Augenklinik der Ludwig Maximilians Universität München; 🇩🇪 München, Germany

VitreoRetinal Surgery, PA; 🇺🇸 Minneapolis, Minnesota, United States

Allegheny Ophthalmic & Orbital Associates, PC; 🇺🇸 Pittsburgh, Pennsylvania, United States