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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913744
First Posted: June 4, 2009
Last Update Posted: December 17, 2014
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.
Information provided by (Responsible Party):
ThromboGenics
  Purpose
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).

Condition Intervention Phase
Exudative Age-Related Macular Degeneration Focal Vitreomacular Adhesion Drug: Ocriplasmin Drug: Sham injection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Drug Information available for: Ocriplasmin
U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • 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
Enrollment: 100
Study Start Date: January 2010
Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin Drug: Ocriplasmin
ocriplasmin intravitreal injection (125 µg)
Sham Comparator: Sham injection Drug: Sham injection
Sham injection

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913744


  Show 27 Study Locations
Sponsors and Collaborators
ThromboGenics
  More Information

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00913744     History of Changes
Other Study ID Numbers: TG-MV-005
First Submitted: June 2, 2009
First Posted: June 4, 2009
Results First Submitted: April 2, 2014
Results First Posted: May 5, 2014
Last Update Posted: December 17, 2014
Last Verified: April 2014

Keywords provided by ThromboGenics:
AMD

Additional relevant MeSH terms:
Macular Degeneration
Tissue Adhesions
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Cicatrix
Fibrosis
Pathologic Processes