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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. Identifier: NCT00913744
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : May 5, 2014
Last Update Posted : December 17, 2014
Information provided by (Responsible Party):

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).

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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)
Study Start Date : January 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ocriplasmin

Arm Intervention/treatment
Experimental: Ocriplasmin Drug: Ocriplasmin
ocriplasmin intravitreal injection (125 µg)

Sham Comparator: Sham injection Drug: Sham injection
Sham injection

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT00913744

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Sponsors and Collaborators
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Responsible Party: ThromboGenics Identifier: NCT00913744    
Other Study ID Numbers: TG-MV-005
First Posted: June 4, 2009    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: December 17, 2014
Last Verified: April 2014
Keywords provided by ThromboGenics:
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Tissue Adhesions
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes