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

NCT00913744 | Completed Phase 2 Results DMC

• 1 other identifier: TG-MV-005
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 27

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).

Conditions

Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion

Keywords

AMD

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28

  The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation

  Day 28

Study Arms (2)

Ocriplasmin

EXPERIMENTAL

Drug: Ocriplasmin

Sham injection

SHAM COMPARATOR

Drug: Sham injection

Interventions

Ocriplasmin DRUG

ocriplasmin intravitreal injection (125 µg)

Ocriplasmin

Sham injection DRUG

Sham injection

Sham injection

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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.

Sponsors & Collaborators

• ThromboGenics: lead

Study Sites (27)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95819, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Center for Retina and Maculla Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center, PC

Augusta, Georgia, 30909, United States

Location

VitreoRetinal Surgery, PA

Minneapolis, Minnesota, 55435, United States

Location

Retina-Vitreous Center, PA

New Brunswick, New Jersey, 08901, United States

Location

Allegheny Ophthalmic & Orbital Associates, PC

Pittsburgh, Pennsylvania, 15212, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates

Kingsport, Tennessee, 37660, United States

Location

Retinal Consultants of Houston,

Houston, Texas, 78730, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

U.Z. Leuven St. Rafaël Hospital

Leuven, B-3300, Belgium

Location

Rabelais Ophthalmologic Center

Lyon, F-69003, France

Location

Centre Paradis-Monticelli

Marseille, F-13008, France

Location

Centre Ophtalmologique d'Imagerie et de Laser

Paris, 75015, France

Location

Centre Ophtalmologique de L'Odeon

Paris, F75006, France

Location

Universität Bonn Augenklinik

Bonn, D-53127, Germany

Location

Universität Lübeck Universitätsklinikum Schleswig-Holstein

Lübeck, D-23538, Germany

Location

Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg

Marburg, D-35043, Germany

Location

Augenklinik der Ludwig Maximilians Universität München

München, 80336, Germany

Location

University of Milan Department of Clinical Science "Luigi Sacco"

Milan, Italy

Location

Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology

Rome, I-00168, Italy

Location

Frimley Park Hospital

Frimley, Camberley, GU16 7UJ, United Kingdom

Location

Royal Liverpool & Broadgreen Hospital

Liverpool, L7 8XP, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Wolverhampton Eye Infirmary New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Interventions

microplasmin; salicylhydroxamic acid

Results Point of Contact

• Title: Dr. Petra Kozma-Wiebe
• Organization: ThromboGenics NV

Petra.kozma@thrombogenics.com

+32 16 751 310

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2009
• First Posted: June 4, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: December 17, 2014
• Results First Posted: May 5, 2014

Record last verified: 2014-04

Locations

FR (4); GB (4); BE (1); US (12); IT (2); DE (4)