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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00913744
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : May 5, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

Tracking Information
First Submitted Date  ICMJE June 2, 2009
First Posted Date  ICMJE June 4, 2009
Results First Submitted Date  ICMJE April 2, 2014
Results First Posted Date  ICMJE May 5, 2014
Last Update Posted Date December 17, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2014)
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 [ Time Frame: Day 28 ]
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Proportion of subjects with release of focal vitreomacular adhesion by day 56 as determined by masked Central Reading Center [ Time Frame: Day 56 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2009)
Vitreomacular adhesion status and PVD status at visits other than day 56 post-injection visit (OCT and ultrasound) [ Time Frame: Visits other than day 56 post-injection visit (OCT and ultrasound) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Exudative Age-Related Macular Degeneration
  • Focal Vitreomacular Adhesion
Intervention  ICMJE
  • Drug: Ocriplasmin
    ocriplasmin intravitreal injection (125 µg)
  • Drug: Sham injection
    Sham injection
Study Arms  ICMJE
  • Experimental: Ocriplasmin
    Intervention: Drug: Ocriplasmin
  • Sham Comparator: Sham injection
    Intervention: Drug: Sham injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2009)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00913744
Other Study ID Numbers  ICMJE TG-MV-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ThromboGenics
Study Sponsor  ICMJE ThromboGenics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ThromboGenics
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP