Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00913744
First received: June 2, 2009
Last updated: March 8, 2012
Last verified: March 2012
History of Changes
  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 patients 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 release of focal vitreomacular adhesion by day 28 as determined by masked Central Reading Center [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vitreomacular adhesion status and PVD status at visits other than day 28 post-injection visit (OCT and ultrasound) [ Time Frame: Visits other than day 28 post-injection visit (OCT and ultrasound) ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects aged > 50
  2. Presence of focal vitreomacular adhesion measured by 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 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 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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913744

  Show 29 Study Locations
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00913744     History of Changes
Other Study ID Numbers: TG-MV-005
Study First Received: June 2, 2009
Last Updated: March 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Italy: The Italian Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by ThromboGenics:
AMD

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

ClinicalTrials.gov processed this record on May 23, 2013