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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Macular Edema
Interventions Drug: ocriplasmin
Other: Sham injection
Enrollment 51
Recruitment Details The first patient was enrolled on 15 December 2006 and the last patient completed the last visit on 19 January 2010. All patients were selected in medical clinics
Pre-assignment Details The trial investigated 3 doses: 25, 75 and 125µg in 3 consecutive cohorts. Patients in each cohort were to be randomized to active treatment or sham injection in a 3:1 ratio. Enrolment into the high dose microplasmin groups was to start only after acceptable safety had been achieved with the previous doses as determined by a Study Safety Committee.
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg 0criplasmin 125µg Sham Injection
Hide Arm/Group Description 25µg ocriplasmin intravitreal injections versus sham injection 75µg ocriplasmin intravitreal injection versus sham injection 125µg ocriplasmin intravitreal injection versus sham injection Sham intravitreal injection
Period Title: Overall Study
Started 8 15 15 13
Completed 8 15 14 11
Not Completed 0 0 1 2
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection Total
Hide Arm/Group Description 25µg ocriplasmin intravitreal injection versus sham injection 75µg ocriplasmin intravitreal injection versus sham injection 125µg ocriplasmin intravitreal injection versus sham injection

Sham injection

Sham injection : Sham intravitreal injection

Total of all reporting groups
Overall Number of Baseline Participants 8 15 15 13 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 15 participants 15 participants 13 participants 51 participants
61.6  (9.8) 67.3  (8.8) 61.7  (13.4) 69.9  (6.2) 63.9  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 15 participants 15 participants 13 participants 51 participants
Female
5
  62.5%
6
  40.0%
4
  26.7%
4
  30.8%
19
  37.3%
Male
3
  37.5%
9
  60.0%
11
  73.3%
9
  69.2%
32
  62.7%
1.Primary Outcome
Title PVD Induction
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection
Hide Arm/Group Description:
25µg ocriplasmin intravitreal injection versus sham injection
75µg ocriplasmin intravitreal injection versus sham injection
125µg ocriplasmin intravitreal injection versus sham injection

Sham injection

Sham injection : Sham intravitreal injection

Overall Number of Participants Analyzed 8 15 15 13
Measure Type: Number
Unit of Measure: percentage of participants
0 20 13.3 30.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 25µg, Sham Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.001
Confidence Interval (2-Sided) 95%
0.001 to 999.999
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 75µg, Sham Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.562
Confidence Interval (2-Sided) 95%
0.132 to 2.400
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 125µg, Sham Injection
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.372
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.346
Confidence Interval 95%
0.070 to 1.703
Estimation Comments [Not Specified]
Time Frame AEs/SAEs were collected from injection day up to Month 12 post-injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection
Hide Arm/Group Description 25µg ocriplasmin intravitreal injection versus sham injection 75µg ocriplasmin intravitreal injection versus sham injection 125µg ocriplasmin intravitreal injection versus sham injection

Sham injection

Sham injection : Sham intravitreal injection

All-Cause Mortality
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      4/15 (26.67%)      5/15 (33.33%)      9/13 (69.23%)    
Cardiac disorders         
Angina pectoris  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Atrioventricular block complete  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Cardiac arrest  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Myocardial infaction  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Myocardial ischaemia  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Eye disorders         
maculopathy  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Macular oedema  1  0/8 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/13 (0.00%)  0
Optic disc vascular disorder  1  0/8 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/13 (0.00%)  0
Retinal artery occlusion  1  0/8 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/13 (0.00%)  0
Gastrointestinal disorders         
Intestinal obstruction  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Oesophageal varices haemorrhage  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Infections and infestations         
Urosepsis  1  1/8 (12.50%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/13 (0.00%)  0
Metabolism and nutrition disorders         
Diabetes mellitus inadequate control  1  0/8 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/13 (0.00%)  0
Hyperglycaemia  1  0/8 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/13 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  0/8 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/13 (7.69%)  1
Nervous system disorders         
Monoparesis  1  0/8 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/13 (0.00%)  0
Vascular disorders         
Haematoma  1  0/8 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/13 (0.00%)  0
Hypovolaemic shock  1  0/8 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/13 (0.00%)  0
Thrombosis  1  0/8 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/13 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Sham Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      4/15 (26.67%)      5/15 (33.33%)      7/13 (53.85%)    
Cardiac disorders         
Angina Pectoris  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Atrioventricular block complete  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Cardiac arrest  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Myocardial infarction  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Myocardial ischaemia  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Eye disorders         
Maculopathy  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Macular oedema  1  0/8 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/13 (0.00%) 
Optic disc vascular disorder  1  0/8 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/13 (0.00%) 
Retinal artery occlusion  1  0/8 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/13 (0.00%) 
Infections and infestations         
Urosepsis  1  1/8 (12.50%)  0/15 (0.00%)  0/15 (0.00%)  0/13 (0.00%) 
Metabolism and nutrition disorders         
Diabetes mellitus inadequate control  1  0/8 (0.00%)  1/15 (6.67%)  0/15 (0.00%)  0/13 (0.00%) 
Hyperglycaemia  1  0/8 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  0/8 (0.00%)  0/15 (0.00%)  0/15 (0.00%)  1/13 (7.69%) 
Nervous system disorders         
Monoparesis  1  0/8 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Vascular disorders         
Heamatoma  1  0/8 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Hypovolaemic shock  1  0/8 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Thrombosis  1  0/8 (0.00%)  0/15 (0.00%)  1/15 (6.67%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Petra Kozma-Wiebe, MD
Organization: ThromboGenics NV
Phone: +32 16751310
EMail: petra.kozma@thrombogenics.com
Layout table for additonal information
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00412451    
Other Study ID Numbers: TG-MV-002
First Submitted: December 14, 2006
First Posted: December 18, 2006
Results First Submitted: July 4, 2013
Results First Posted: September 13, 2013
Last Update Posted: December 17, 2014