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

Primary Purpose

Exudative Age-Related Macular Degeneration, Focal Vitreomacular Adhesion

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ocriplasmin
Sham injection
Sponsored by
ThromboGenics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Exudative Age-Related Macular Degeneration focused on measuring AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Retinal Consultants Medical Group
  • University of Colorado Denver
  • Center for Retina and Maculla Disease
  • Southeast Retina Center, PC
  • VitreoRetinal Surgery, PA
  • Retina-Vitreous Center, PA
  • Allegheny Ophthalmic & Orbital Associates, PC
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates
  • Retinal Consultants of Houston,
  • Valley Retina Institute
  • U.Z. Leuven St. Rafaël Hospital
  • Rabelais Ophthalmologic Center
  • Centre Paradis-Monticelli
  • Centre Ophtalmologique d'Imagerie et de Laser
  • Centre Ophtalmologique de L'Odeon
  • Universität Bonn Augenklinik
  • Universität Lübeck Universitätsklinikum Schleswig-Holstein
  • Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
  • Augenklinik der Ludwig Maximilians Universität München
  • University of Milan Department of Clinical Science "Luigi Sacco"
  • Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
  • Frimley Park Hospital
  • Royal Liverpool & Broadgreen Hospital
  • Moorfields Eye Hospital
  • Wolverhampton Eye Infirmary New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Ocriplasmin

Sham injection

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 2, 2009
Last Updated
December 2, 2014
Sponsor
ThromboGenics
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1. Study Identification

Unique Protocol Identification Number
NCT00913744
Brief Title
Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
Acronym
MIVI-5
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exudative Age-Related Macular Degeneration, Focal Vitreomacular Adhesion
Keywords
AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocriplasmin
Arm Type
Experimental
Arm Title
Sham injection
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Ocriplasmin
Intervention Description
ocriplasmin intravitreal injection (125 µg)
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
Sham injection
Primary Outcome Measure Information:
Title
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
Description
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Center for Retina and Maculla Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
VitreoRetinal Surgery, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Retina-Vitreous Center, PA
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Allegheny Ophthalmic & Orbital Associates, PC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Southeastern Retina Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Retinal Consultants of Houston,
City
Houston,
State/Province
Texas
ZIP/Postal Code
78730
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
U.Z. Leuven St. Rafaël Hospital
City
Leuven
ZIP/Postal Code
B-3300
Country
Belgium
Facility Name
Rabelais Ophthalmologic Center
City
Lyon
ZIP/Postal Code
F-69003
Country
France
Facility Name
Centre Paradis-Monticelli
City
Marseilles
ZIP/Postal Code
F-13008
Country
France
Facility Name
Centre Ophtalmologique d'Imagerie et de Laser
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Ophtalmologique de L'Odeon
City
Paris
ZIP/Postal Code
F75006
Country
France
Facility Name
Universität Bonn Augenklinik
City
Bonn
ZIP/Postal Code
D-53127
Country
Germany
Facility Name
Universität Lübeck Universitätsklinikum Schleswig-Holstein
City
Lübeck
ZIP/Postal Code
D-23538
Country
Germany
Facility Name
Klinik für Augenheilkunde, Universitätsklinikum Gießen, Standort Marburg
City
Marburg
ZIP/Postal Code
D-35043
Country
Germany
Facility Name
Augenklinik der Ludwig Maximilians Universität München
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
University of Milan Department of Clinical Science "Luigi Sacco"
City
Milan
Country
Italy
Facility Name
Largo Agostino Gemelli (University Hospital) Institute of Ophthalmology
City
Rome
ZIP/Postal Code
I-00168
Country
Italy
Facility Name
Frimley Park Hospital
City
Frimley
State/Province
Camberley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Facility Name
Royal Liverpool & Broadgreen Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Facility Name
Wolverhampton Eye Infirmary New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

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

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