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A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) (MIVI-II)

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ClinicalTrials.gov Identifier: NCT00412451
Recruitment Status : Completed
First Posted : December 18, 2006
Results First Posted : September 13, 2013
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
ThromboGenics

December 14, 2006
December 18, 2006
July 4, 2013
September 13, 2013
December 17, 2014
December 2006
January 2010   (Final data collection date for primary outcome measure)
PVD Induction [ Time Frame: Day 14 post-injection ]
The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)
PVD Induction
Complete list of historical versions of study NCT00412451 on ClinicalTrials.gov Archive Site
Not Provided
Clinical assessments
Not Provided
Not Provided
 
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of DME.
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Macular Edema
  • Drug: ocriplasmin
    Intravitreal injection, single administration
    Other Name: microplasmin
  • Other: Sham injection
    Sham intravitreal injection
  • Experimental: Ocriplasmin 25µg
    25µg ocriplasmin intravitreal injection versus sham injection
    Intervention: Drug: ocriplasmin
  • Experimental: Ocriplasmin 75µg
    75µg ocriplasmin intravitreal injection versus sham injection
    Intervention: Drug: ocriplasmin
  • Experimental: Ocriplasmin 125µg
    125µg ocriplasmin intravitreal injection versus sham injection
    Intervention: Drug: ocriplasmin
  • Sham Comparator: sham injection
    Sham injection
    Intervention: Other: Sham injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
60
March 2010
January 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria include:

  • patients >18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

  • PVD present at baseline
  • Vitreous hemorrhage
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Patients who have had a vitrectomy in the study eye at any time
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Italy,   Netherlands,   Spain,   United Kingdom
Ireland
 
NCT00412451
TG-MV-002
Yes
Not Provided
Not Provided
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