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

• 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: ThromboGenics
• Information provided by (Responsible Party): ThromboGenics

Tracking Information

• First Submitted Date: June 2, 2009
• First Posted Date: June 4, 2009
• Results First Submitted Date: April 2, 2014
• Results First Posted Date: May 5, 2014
• Last Update Posted Date: December 17, 2014
• Study Start Date: January 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (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: Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion
• 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)
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Exudative Age-Related Macular Degeneration
• Focal Vitreomacular Adhesion

Intervention

• Drug: Ocriplasmin
  ocriplasmin intravitreal injection (125 µg)
• Drug: Sham injection
  Sham injection

Study Arms

• Experimental: Ocriplasmin
  Intervention: Drug: Ocriplasmin
• Sham Comparator: Sham injection
  Intervention: Drug: Sham injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2009): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: April 2013
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, France, Germany, Italy, United Kingdom, United States

Administrative Information

• NCT Number: NCT00913744
• Other Study ID Numbers: TG-MV-005
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ThromboGenics
• Study Sponsor: ThromboGenics
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ThromboGenics
• Verification Date: April 2014