ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    22894573 [PUBMED-IDS]
Previous Study | Return to List | Next Study

Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

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: NCT00798317
Recruitment Status : Completed
First Posted : November 26, 2008
Results First Posted : January 30, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Vitreomacular Adhesion
Interventions Drug: Ocriplasmin 125µg
Drug: Placebo
Enrollment 326
Recruitment Details First patient was recruited on 23 Dec 2008 and last patient completed the study on 15 Jun 2010
Pre-assignment Details  
Arm/Group Title Ocriplasmin 125µg Placebo
Hide Arm/Group Description 125µg ocriplasmin intravitreal injection. Intravitreal injection of placebo
Period Title: Overall Study
Started 245 81
Completed 235 74
Not Completed 10 7
Reason Not Completed
Physician Decision             0             1
Withdrawal by Subject             5             4
Lost to Follow-up             2             2
Adverse Event             2             0
Death             1             0
Arm/Group Title Ocriplasmin 125µg Placebo Total
Hide Arm/Group Description 125µg ocriplasmin intravitreal injection. Intravitreal injection of placebo Total of all reporting groups
Overall Number of Baseline Participants 245 81 326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 245 participants 81 participants 326 participants
72.6  (7.56) 70.2  (10.85) 72.0  (8.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 245 participants 81 participants 326 participants
Female
166
  67.8%
56
  69.1%
222
  68.1%
Male
79
  32.2%
25
  30.9%
104
  31.9%
1.Primary Outcome
Title Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Hide Description Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
Arm/Group Title Ocriplasmin 125µg Placebo
Hide Arm/Group Description:
125µg ocriplasmin intravitreal injection
Intravitreal injection of placebo
Overall Number of Participants Analyzed 245 81
Measure Type: Number
Unit of Measure: percentage of participants
25.3 6.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 125µg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Comparing placebo and ocriplasmin
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.13
Confidence Interval (2-Sided) 95%
1.97 to 17.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Hide Description Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Time Frame Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)
Arm/Group Title Ocriplasmin 125µg Placebo
Hide Arm/Group Description:
125µg ocriplasmin intravitreal injection
Intravitreal injection of placebo
Overall Number of Participants Analyzed 245 81
Measure Type: Number
Unit of Measure: percentage of participants
10.6 0
Time Frame Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months after injection
Adverse Event Reporting Description AEs/SAEs were assessed by the investigator at all study visits
 
Arm/Group Title Ocriplasmin 125ug Placebo
Hide Arm/Group Description 125ug ocriplasmin intravitreal injection Intravitreal injection of placebo
All-Cause Mortality
Ocriplasmin 125ug Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ocriplasmin 125ug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/245 (13.47%)      11/81 (13.58%)    
Cardiac disorders     
Angina unstable  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Atrial fibrilation  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Sick sinus syndrome  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Eye disorders     
Macular hole  1  9/245 (3.67%)  9 5/81 (6.17%)  5
Vitreous adhesions  1  3/245 (1.22%)  3 1/81 (1.23%)  1
Visual acuity reduced  1  2/245 (0.82%)  2 1/81 (1.23%)  1
Eye inflammation  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Hyphaema  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Macular oedema  1  0/245 (0.00%)  0 1/81 (1.23%)  1
Posterior capsule opacification  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Retinal detachment  1  0/245 (0.00%)  0 1/81 (1.23%)  2
Vitreous haemorrhage  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Upper limb fracture  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Wrist fracture  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Transient ischaemic attack  1  0/245 (0.00%)  0 1/81 (1.23%)  1
Arteriosclerosis coronay artery  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal haemorrahge  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Pancreatitis  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Infections and infestations     
Diverticulitis  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Penumonia  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Injury, poisoning and procedural complications     
Femur fracture  1  0/245 (0.00%)  0 1/81 (1.23%)  1
Joint dislocation  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Rib fracture  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Spinal compression fracture  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Spinal fracture  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Reumathoid arthritis  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain cancer metastatic  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Breast cancer  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Lung neoplasm malignant  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Nervous system disorders     
Syncope  1  2/245 (0.82%)  2 0/81 (0.00%)  0
Epilepsy  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Presyncope  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Psychiatric disorders     
Depression  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Renal and urinary disorders     
Renal failure acute  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Respiratory distress  1  1/245 (0.41%)  1 0/81 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin 125ug Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   105/245 (42.86%)      22/81 (27.16%)    
Eye disorders     
Vitreous floaters  1  38/245 (15.51%)  40 6/81 (7.41%)  8
Conjuctival haemorrahge  1  34/245 (13.88%)  34 10/81 (12.35%)  10
Eye pain  1  30/245 (12.24%)  33 5/81 (6.17%)  5
Photopsia  1  19/245 (7.76%)  21 1/81 (1.23%)  1
Vision blurred  1  17/245 (6.94%)  18 3/81 (3.70%)  3
Visual acuity reduced  1  13/245 (5.31%)  13 2/81 (2.47%)  2
Macular oedema  1  13/245 (5.31%)  13 3/81 (3.70%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Varying agreements. The most restrictive is as follows: The Centre and Investigator agree to neither publish nor make public any of the results of the Study without the prior written consent from Sponsor, which consent shall not be unreasonably withheld.
Results Point of Contact
Name/Title: Petra Kozma-Wiebe
Organization: ThromboGenics
Phone: +32 16751310
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00798317     History of Changes
Other Study ID Numbers: TG-MV-007
First Submitted: November 25, 2008
First Posted: November 26, 2008
Results First Submitted: December 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: December 17, 2014