A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00412958
First received: December 18, 2006
Last updated: April 4, 2014
Last verified: April 2014

December 18, 2006
April 4, 2014
December 2006
October 2008   (final data collection date for primary outcome measure)
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
PVD Induction
Complete list of historical versions of study NCT00412958 on ClinicalTrials.gov Archive Site
Not Provided
Safety, Ultrasounds
Not Provided
Not Provided
 
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Vitrectomy
  • Drug: Ocriplasmin 25µg
    Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
    Other Name: Microplasmin
  • Drug: Ocriplasmin 75µg
    Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
    Other Name: Microplasmin
  • Drug: Ocriplasmin 125µg
    Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
    Other Name: Microplasmin
  • Drug: Placebo
    Intravitreal injection of placebo
  • Experimental: Ocriplasmin 25µg
    25µg of ocriplasmin intravitreal injection
    Intervention: Drug: Ocriplasmin 25µg
  • Experimental: Ocriplasmin 75µg
    75µg of ocriplasmin intravitreal injection
    Intervention: Drug: Ocriplasmin 75µg
  • Experimental: Ocriplasmin 125µg
    125µg of ocriplasmin intravitreal injection
    Intervention: Drug: Ocriplasmin 125µg
  • Placebo Comparator: Placebo
    Intravitreal injection of placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients in whom vitrectomy is indicated

Exclusion Criteria:

  • Posterior Vitreous Detachment (PVD) present at baseline
  • Vitreous hemorrhage
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Have had a vitrectomy in the study eye at any time
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00412958
TG-MV-003
Yes
ThromboGenics
ThromboGenics
Not Provided
Not Provided
ThromboGenics
April 2014

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