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Trial record 21 of 615 for:    PLG

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

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: NCT00412958
Recruitment Status : Completed
First Posted : December 19, 2006
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 Vitrectomy
Interventions Drug: Ocriplasmin 25µg
Drug: Ocriplasmin 75µg
Drug: Ocriplasmin 125µg
Drug: Placebo
Enrollment 125
Recruitment Details The first patient was recruited on 29 Mar 2007 and the last patient completed the study on 02 Oct 2008.
Pre-assignment Details  
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Hide Arm/Group Description 25µg ocriplasmin intravitreal injection. 75µg ocriplasmin intravitreal injection. 125µg ocriplasmin intravitreal injection. Intravitreal injection of placebo.
Period Title: Overall Study
Started 29 33 32 31
Completed 26 29 32 30
Not Completed 3 4 0 1
Reason Not Completed
Withdrawal by Subject             3             0             0             1
Adverse Event             0             1             0             0
Lost to Follow-up             0             1             0             0
Death             0             1             0             0
Transport issue             0             1             0             0
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo Total
Hide Arm/Group Description 25µg ocriplasmin intravitreal injection 75µg ocriplasmin intravitreal injection. 125µg ocriplasmin intravitreal injection. Intravitreal injection of placebo. Total of all reporting groups
Overall Number of Baseline Participants 29 33 32 31 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 33 participants 32 participants 31 participants 125 participants
66.9  (8.28) 68.8  (9.07) 66.9  (11.40) 65.7  (11.60) 66.1  (10.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 33 participants 32 participants 31 participants 125 participants
Female
20
  69.0%
23
  69.7%
20
  62.5%
22
  71.0%
85
  68.0%
Male
9
  31.0%
10
  30.3%
12
  37.5%
9
  29.0%
40
  32.0%
1.Primary Outcome
Title Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
Hide Description 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.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT). Full Analysis Set.
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Hide Arm/Group Description:
25µg ocriplasmin intravitreal injection.
75µg ocriplasmin intravitreal injection.
125µg ocriplasmin intravitreal injection.
Intravitreal injection of placebo.
Overall Number of Participants Analyzed 29 33 32 30
Measure Type: Number
Unit of Measure: percentage of participants
13.8 18.2 31.3 10
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 25µg, Placebo
Comments P-values are from Wald chi-square tests from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.24 to 6.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 75µg, Placebo
Comments P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.447
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.81
Confidence Interval (2-Sided) 95%
0.39 to 8.36
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ocriplasmin 125µg, Placebo
Comments P-values are from Wald chi-square test from a logistic regression model with study center and treatment as categorical fixed effects comparing active treatment groups with the placebo group as the reference group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.28
Confidence Interval (2-Sided) 95%
0.77 to 13.95
Estimation Comments [Not Specified]
Time Frame Adverse Events(AEs)/Serious Adverse Events(SAEs) were collected from injection day up to Day 180 post-injection.
Adverse Event Reporting Description AEs/SAEs were assessed by the investigator at all study visits.
 
Arm/Group Title Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Hide Arm/Group Description 25µg of ocriplasmin intravitreal injection. 75µg of ocriplasmin intravitreal injection. 125µg of ocriplasmin intravitreal injection. Intravitreal injection of placebo.
All-Cause Mortality
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/29 (6.90%)      3/33 (9.09%)      0/32 (0.00%)      2/31 (6.45%)    
Cardiac disorders         
Myocardial infarction  1  0/29 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0
Eye disorders         
Anterior chamber inflammation  1  1/29 (3.45%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations         
Diverticulitis  1  1/29 (3.45%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0
Pneumonia  1  0/29 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/31 (3.23%)  1
Sinutis  1  0/29 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders         
Radius fracture  1  0/29 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/31 (3.23%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bening pancreatic neoplasm  1  0/29 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0
Vascular disorders         
Hypertension  1  0/29 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin 25µg Ocriplasmin 75µg Ocriplasmin 125µg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/29 (100.00%)      32/33 (96.97%)      31/32 (96.88%)      30/31 (96.77%)    
Eye disorders         
Conjunctival haemorrahge  1  14/29 (48.28%)  17 18/33 (54.55%)  22 17/32 (53.13%)  18 22/31 (70.97%)  22
Anterior chamber cell  1  12/29 (41.38%)  13 13/33 (39.39%)  17 13/32 (40.63%)  16 7/31 (22.58%)  8
Anterior chamber flare  1  6/29 (20.69%)  6 7/33 (21.21%)  9 11/32 (34.38%)  12 6/31 (19.35%)  6
Cataract nuclear  1  9/29 (31.03%)  13 7/33 (21.21%)  8 8/32 (25.00%)  9 8/31 (25.81%)  12
Macular oedema  1  5/29 (17.24%)  6 10/33 (30.30%)  11 4/32 (12.50%)  4 7/31 (22.58%)  8
Cataract  1  6/29 (20.69%)  6 9/33 (27.27%)  9 7/32 (21.88%)  9 5/31 (16.13%)  5
Eye pain  1  6/29 (20.69%)  7 9/33 (27.27%)  11 4/32 (12.50%)  5 8/31 (25.81%)  11
Eyelid oedema  1  7/29 (24.14%)  8 3/33 (9.09%)  3 3/32 (9.38%)  3 7/31 (22.58%)  7
Retinal haemorrhage  1  7/29 (24.14%)  9 6/33 (18.18%)  6 5/32 (15.63%)  6 7/31 (22.58%)  9
Retinal tear  1  2/29 (6.90%)  2 7/33 (21.21%)  7 4/32 (12.50%)  4 1/31 (3.23%)  1
Retinal depigmentation  1  6/29 (20.69%)  6 6/33 (18.18%)  7 6/32 (18.75%)  6 4/31 (12.90%)  4
Ocular discomfort  1  5/29 (17.24%)  5 2/33 (6.06%)  2 4/32 (12.50%)  4 5/31 (16.13%)  5
Maculopathy  1  4/29 (13.79%)  4 5/33 (15.15%)  6 2/32 (6.25%)  2 5/31 (16.13%)  5
Vitreous floaters  1  2/29 (6.90%)  2 5/33 (15.15%)  6 4/32 (12.50%)  4 5/31 (16.13%)  5
Ocular hyperaemia  1  4/29 (13.79%)  6 1/33 (3.03%)  2 3/32 (9.38%)  3 0/31 (0.00%)  0
Retinal disorder  1  3/29 (10.34%)  3 3/33 (9.09%)  3 4/32 (12.50%)  5 2/31 (6.45%)  3
Cataract subcapsular  1  0/29 (0.00%)  0 4/33 (12.12%)  8 0/32 (0.00%)  0 1/31 (3.23%)  1
Macular degeneration  1  2/29 (6.90%)  2 4/33 (12.12%)  5 0/32 (0.00%)  0 0/31 (0.00%)  0
Vitreous haemorrhage  1  2/29 (6.90%)  3 4/33 (12.12%)  5 2/32 (6.25%)  3 2/31 (6.45%)  4
Anterior chamber inflammation  1  3/29 (10.34%)  3 0/33 (0.00%)  0 0/32 (0.00%)  0 2/31 (6.45%)  2
Conjunctival oedema  1  3/29 (10.34%)  3 2/33 (6.06%)  2 0/32 (0.00%)  0 1/31 (3.23%)  1
Photophobia  1  3/29 (10.34%)  3 1/33 (3.03%)  1 2/32 (6.25%)  2 0/31 (0.00%)  0
Visual disturbance  1  3/29 (10.34%)  3 1/33 (3.03%)  1 1/32 (3.13%)  1 0/31 (0.00%)  0
Foreign body sensation in eyes  1  1/29 (3.45%)  1 3/33 (9.09%)  4 3/32 (9.38%)  3 3/31 (9.68%)  3
Conjunctival hyperaemia  1  2/29 (6.90%)  2 2/33 (6.06%)  2 3/32 (9.38%)  3 1/31 (3.23%)  1
Corneal disorder  1  1/29 (3.45%)  1 1/33 (3.03%)  1 3/32 (9.38%)  3 0/31 (0.00%)  0
Lacrimation increased  1  1/29 (3.45%)  1 3/33 (9.09%)  4 0/32 (0.00%)  0 2/31 (6.45%)  2
Vision blurred  1  2/29 (6.90%)  2 3/33 (9.09%)  3 2/32 (6.25%)  2 1/31 (3.23%)  1
Vitreous disorder  1  0/29 (0.00%)  0 3/33 (9.09%)  3 1/32 (3.13%)  1 2/31 (6.45%)  2
Corneal bleeding  1  2/29 (6.90%)  2 0/33 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0
Eye pruritus  1  2/29 (6.90%)  2 2/33 (6.06%)  2 0/32 (0.00%)  0 0/31 (0.00%)  0
Photopsia  1  2/29 (6.90%)  2 0/33 (0.00%)  0 2/32 (6.25%)  2 2/31 (6.45%)  2
Cataract cortical  1  1/29 (3.45%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 2/31 (6.45%)  2
Corneal oedema  1  1/29 (3.45%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 2/31 (6.45%)  2
Retinal cyst  1  0/29 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 2/31 (6.45%)  2
Macular hole  1  1/29 (3.45%)  1 2/33 (6.06%)  2 2/32 (6.25%)  2 0/31 (0.00%)  0
Corneal striae  1  0/29 (0.00%)  0 2/33 (6.06%)  2 1/32 (3.13%)  1 0/31 (0.00%)  0
Eye inflammation  1  1/29 (3.45%)  1 2/33 (6.06%)  2 0/32 (0.00%)  0 1/31 (3.23%)  1
Retinal degeneration  1  1/29 (3.45%)  1 2/33 (6.06%)  2 0/32 (0.00%)  0 0/31 (0.00%)  0
Retinal detachment  1  0/29 (0.00%)  0 2/33 (6.06%)  4 0/32 (0.00%)  0 1/31 (3.23%)  2
Retinal oedema  1  1/29 (3.45%)  1 2/33 (6.06%)  2 3/32 (9.38%)  3 0/31 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  0/29 (0.00%)  0 5/33 (15.15%)  5 1/32 (3.13%)  1 1/31 (3.23%)  1
General disorders         
Oedema peripheral  1 [1]  2/29 (6.90%)  2 1/33 (3.03%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0
Asthenia  1 [1]  0/29 (0.00%)  0 2/33 (6.06%)  2 0/32 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  0/29 (0.00%)  0 2/33 (6.06%)  2 1/32 (3.13%)  1 1/31 (3.23%)  1
Investigations         
Intraocular pressure increased  1  4/29 (13.79%)  4 4/33 (12.12%)  5 6/32 (18.75%)  6 5/31 (16.13%)  5
Intraocular pressure decreased  1  0/29 (0.00%)  0 1/33 (3.03%)  1 1/32 (3.13%)  1 2/31 (6.45%)  2
Nervous system disorders         
Headache  1  0/29 (0.00%)  0 2/33 (6.06%)  2 1/32 (3.13%)  1 5/31 (16.13%)  6
Dizziness  1  0/29 (0.00%)  0 1/33 (3.03%)  1 2/32 (6.25%)  2 1/31 (3.23%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 10.1.
[1]
Originally coded to General disorders and administration site conditions
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
Name/Title: Petra Kozma-Wiebe, MD
Organization: ThromboGenics
Phone: +32 16751310
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00412958     History of Changes
Other Study ID Numbers: TG-MV-003
First Submitted: December 18, 2006
First Posted: December 19, 2006
Results First Submitted: December 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: December 17, 2014