Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)

A Randomized, Sham-Injection Controlled, Double-Masked, Multicenter Trial of Ocriplasmin Intravitreal Injection for Treatment of Focal Vitreomacular Adhesion in Subjects With Exudative Age-Related Macular Degeneration (AMD)

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).

Study Overview

• Status: Completed
• Conditions: Exudative Age-Related Macular Degeneration; Focal Vitreomacular Adhesion
• Intervention / Treatment: Drug: Ocriplasmin; Drug: Sham injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3300
    • U.Z. Leuven St. Rafaël Hospital
• France
  • Lyon, France, F-69003
    • Rabelais Ophthalmologic Center
  • Marseilles, France, F-13008
    • Centre Paradis-Monticelli
  • Paris, France, 75015
    • Centre Ophtalmologique d'Imagerie et de Laser
  • Paris, France, F75006
    • Centre Ophtalmologique de L'Odeon
• Germany
  • Bonn, Germany, D-53127
    • Universität Bonn Augenklinik
  • Lübeck, Germany, D-23538
    • Universität Lübeck Universitätsklinikum Schleswig-Holstein
  • Marburg, Germany, D-35043
    • Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
  • München, Germany, 80336
    • Augenklinik der Ludwig Maximilians Universität München
• Italy
  • Milan, Italy
    • University of Milan Department of Clinical Science "Luigi Sacco"
  • Rome, Italy, I-00168
    • Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
• United Kingdom
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool & Broadgreen Hospital
  • London, United Kingdom, EC1V 2PD
    • Moorfields Eye Hospital
  • Wolverhampton, United Kingdom, WV10 0QP
    • Wolverhampton Eye Infirmary New Cross Hospital
  • Camberley
    • Frimley, Camberley, United Kingdom, GU16 7UJ
      • Frimley Park Hospital
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Sacramento, California, United States, 95819
      • Retinal Consultants Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Florida
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Maculla Disease
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • VitreoRetinal Surgery, PA
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Retina-Vitreous Center, PA
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Ophthalmic & Orbital Associates, PC
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Southeastern Retina Associates
  • Texas
    • Houston,, Texas, United States, 78730
      • Retinal Consultants of Houston,
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham injection	Drug: Sham injection; Sham injection
Experimental: Ocriplasmin	Drug: Ocriplasmin; ocriplasmin intravitreal injection (125 µg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: ThromboGenics

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: June 2, 2009
• First Submitted That Met QC Criteria: June 3, 2009
• First Posted (Estimate): June 4, 2009

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: AMD
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Fibrosis; Cicatrix; Macular Degeneration; Tissue Adhesions; Wet Macular Degeneration
• Other Study ID Numbers: TG-MV-005