Back to resultsA Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) (MIVI-II)
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ocriplasmin
Sham injection
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
Eligibility Criteria
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
Sites / Locations
- ZNA OCMW Antwerpen
- University Hospital of Ghent
- University Hospital Leuven
- Ludwig Maximillian University
- University of Milan
- Azienda Ospedaliero-Universitaria Pisana
- Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
- Ospedale di Circolo di Varese, Insubria University
- Academic Hospital Groningen
- Het Oogziekenhuis Rotterdam
- Institut de Microcirurgia Ocular de Barcelona
- Hospital Vall D'Hebron
- Instituto Technologico de Oftalmologia SL.
- Royal Liverpool & Broadgreen Hospital
- Moorfields Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Ocriplasmin 25µg
Ocriplasmin 75µg
Ocriplasmin 125µg
sham injection
Arm Description
25µg ocriplasmin intravitreal injection versus sham injection
75µg ocriplasmin intravitreal injection versus sham injection
125µg ocriplasmin intravitreal injection versus sham injection
Sham injection
Outcomes
Primary Outcome Measures
PVD Induction
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00412451
Brief Title
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
Acronym
MIVI-II
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThromboGenics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, PVD, DME, Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ocriplasmin 25µg
Arm Type
Experimental
Arm Description
25µg ocriplasmin intravitreal injection versus sham injection
Arm Title
Ocriplasmin 75µg
Arm Type
Experimental
Arm Description
75µg ocriplasmin intravitreal injection versus sham injection
Arm Title
Ocriplasmin 125µg
Arm Type
Experimental
Arm Description
125µg ocriplasmin intravitreal injection versus sham injection
Arm Title
sham injection
Arm Type
Sham Comparator
Arm Description
Sham injection
Intervention Type
Drug
Intervention Name(s)
ocriplasmin
Other Intervention Name(s)
microplasmin
Intervention Description
Intravitreal injection, single administration
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
Sham intravitreal injection
Primary Outcome Measure Information:
Title
PVD Induction
Description
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)
Time Frame
Day 14 post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ZNA OCMW Antwerpen
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
University Hospital of Ghent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
Country
Belgium
Facility Name
Ludwig Maximillian University
City
Munich
Country
Germany
Facility Name
University of Milan
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
Country
Italy
Facility Name
Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale di Circolo di Varese, Insubria University
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Academic Hospital Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
Het Oogziekenhuis Rotterdam
City
Rotterdam
ZIP/Postal Code
3011 BH
Country
Netherlands
Facility Name
Institut de Microcirurgia Ocular de Barcelona
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Instituto Technologico de Oftalmologia SL.
City
Santiago de Compostela
Country
Spain
Facility Name
Royal Liverpool & Broadgreen Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
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