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Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)

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ClinicalTrials.gov Identifier: NCT00913744
Recruitment Status : Completed
First Posted : June 4, 2009
Results First Posted : May 5, 2014
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
Conditions Exudative Age-Related Macular Degeneration
Focal Vitreomacular Adhesion
Interventions Drug: Ocriplasmin
Drug: Sham injection
Enrollment 100
Recruitment Details First subject was enrolled on 29 Jan 2010 and last subject completed the study on 06 Dec 2012
Pre-assignment Details  
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description Intravitreal injection (125 µg) Sham injection
Period Title: Overall Study
Started 75 25
Completed 70 24
Not Completed 5 1
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             2             1
Death             1             0
Arm/Group Title Ocriplasmin Sham Total
Hide Arm/Group Description Intravitreal injection (125 µg) Sham injection Total of all reporting groups
Overall Number of Baseline Participants 74 25 99
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): All randomized subjects who have been administered trial medication and for whom data of at least one post-baseline efficacy assessment is available. One subject (ocriplasmin) was not included in the FAS because the subject withdrew consent after receiving study treatment and refused further contact.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 25 participants 99 participants
74.5  (8.13) 74.7  (7.16) 74.6  (7.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 25 participants 99 participants
Female
39
  52.7%
15
  60.0%
54
  54.5%
Male
35
  47.3%
10
  40.0%
45
  45.5%
1.Primary Outcome
Title Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
Hide Description The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description:
Intravitreal injection (125 µg)
Sham injection
Overall Number of Participants Analyzed 74 25
Measure Type: Number
Unit of Measure: percentage of subjects
24.3 12.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ocriplasmin, Sham
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.262
Comments [Not Specified]
Method Fisher Exact
Comments P-value is from Fisher's exact test, comparing sham and ocriplasmin.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 12.3
Confidence Interval (2-Sided) 95%
-3.7 to 28.4
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to discontinuation, and for a maximum of 12 months after injection.
Adverse Event Reporting Description Safety Set consisted of all subjects who received study treatment and was used for all safety analysis. All subjects were included in the Safety Set: 75 subjects in the ocriplasmin group and 25 subjects in the sham group. AEs and SAEs include ocular events in study eye and non-study eye, as well as non-ocular events.
 
Arm/Group Title Ocriplasmin Sham
Hide Arm/Group Description Intravitreal injection (125 µg) Sham injection
All-Cause Mortality
Ocriplasmin Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ocriplasmin Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/75 (24.00%)      2/25 (8.00%)    
Cardiac disorders     
Myocardial infarction  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Eye disorders     
Retinal detachment  1  3/75 (4.00%)  3 0/25 (0.00%)  0
Visual acuity reduced  1  3/75 (4.00%)  3 0/25 (0.00%)  0
Blindness transient  1  2/75 (2.67%)  2 0/25 (0.00%)  0
Gastrointestinal disorders     
Rectal haemorrhage  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  2/75 (2.67%)  2 0/25 (0.00%)  0
Cystitis  1  0/75 (0.00%)  0 1/25 (4.00%)  1
Endophthalmitis  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Urosepsis  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Injury, poisoning and procedural complications     
Femur fracture  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Joint injury  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Vascular pseudoaneurysm  1  0/75 (0.00%)  0 1/25 (4.00%)  1
Investigations     
Intraocular pressure increased  1  2/75 (2.67%)  2 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Rotator cuff syndrome  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain cancer metastatic  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Prostate cancer metastatic  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Vocal cord neoplasm  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Nervous system disorders     
Dizziness postural  1  0/75 (0.00%)  0 1/25 (4.00%)  1
Surgical and medical procedures     
Vocal cordectomy  1  1/75 (1.33%)  1 0/25 (0.00%)  0
Vascular disorders     
Ateriosclerosis  1  0/75 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ocriplasmin Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/75 (44.00%)      11/25 (44.00%)    
Eye disorders     
Visual acuity reduced  1  12/75 (16.00%)  17 3/25 (12.00%)  5
Photopsia  1  9/75 (12.00%)  10 2/25 (8.00%)  2
Eye pain  1  10/75 (13.33%)  10 0/25 (0.00%)  0
Conjuctival haemorrhage  1  7/75 (9.33%)  8 2/25 (8.00%)  3
Retinal haemorrhage  1  3/75 (4.00%)  3 5/25 (20.00%)  6
Vitreous floaters  1  8/75 (10.67%)  9 0/25 (0.00%)  0
Blepharitis  1  4/75 (5.33%)  4 0/25 (0.00%)  0
Cataract nuclear  1  4/75 (5.33%)  4 0/25 (0.00%)  0
Corneal oedema  1  4/75 (5.33%)  4 0/25 (0.00%)  0
Metamorphosia  1  1/75 (1.33%)  1 2/25 (8.00%)  2
Ulcerative keratitis  1  0/75 (0.00%)  0 2/25 (8.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
Institution and the Principal Investigator (PI) reserve the right to publish only the results of the work performed by the Principal Investigator pursuant to this Agreement; provided, however, that Institution provides Sponsor a copy of any proposed publication, for review and comment at least sixty (60) days in advance of its submission for publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Petra Kozma-Wiebe
Organization: ThromboGenics NV
Phone: +32 16 751 310
EMail: Petra.kozma@thrombogenics.com
Layout table for additonal information
Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00913744    
Other Study ID Numbers: TG-MV-005
First Submitted: June 2, 2009
First Posted: June 4, 2009
Results First Submitted: April 2, 2014
Results First Posted: May 5, 2014
Last Update Posted: December 17, 2014