Safety and Efficacy Study of Intravitreal Ocriplasmin in Subjects With AMD With Focal Vitreomacular Adhesion (MIVI-5)
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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: NCT00913744 |
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Recruitment Status :
Completed
First Posted : June 4, 2009
Results First Posted : May 5, 2014
Last Update Posted : December 17, 2014
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Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
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| 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 |
Participant Flow
| 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 |
|---|---|---|
 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 |
Baseline Characteristics
| Arm/Group Title | Ocriplasmin | Sham | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Intravitreal injection (125 µg) | Sham injection | Total of all reporting groups | |
| Overall Number of Baseline Participants | 74 | 25 | 99 | |
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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.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 74 participants | 25 participants | 99 participants | |
| 74.5 (8.13) | 74.7 (7.16) | 74.6 (7.86) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 74 participants | 25 participants | 99 participants | |
| Female |
39 52.7%
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15 60.0%
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54 54.5%
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| Male |
35 47.3%
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10 40.0%
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45 45.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
| Name/Title: | Dr. Petra Kozma-Wiebe |
| Organization: | ThromboGenics NV |
| Phone: | +32 16 751 310 |
| EMail: | Petra.kozma@thrombogenics.com |
| 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 |