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Trial · NCT00798317

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

NCT00798317, Phase 3, Completed, ThromboGenics; results first posted 2013-01-30

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial. Trials, record NCT00798317. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00798317

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
NCT number
NCT00798317
Status
Completed
Phases
Phase 3
Enrollment
326 participants, actual
Lead sponsor
ThromboGenics
Conditions
Vitreomacular Adhesion
Interventions
Ocriplasmin 125µg, Placebo
First posted
2008-11-26
Last updated
2014-12-17
Results first posted
2013-01-30

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28Day 28Proportion 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.
SecondaryProportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Day 28Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28Day 28Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)percentage of participantsNUMBER
SECONDARYProportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Day 28Intention-To-Treat (ITT), Last Observation Carried Forward LOCF)percentage of participantsNUMBER

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28Ocriplasmin 125µg25.3percentage of participants
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28Placebo6.2percentage of participants
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Ocriplasmin 125µg10.6percentage of participants
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Placebo0percentage of participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOcriplasmin 125µg245
Overall StudySTARTEDPlacebo81
Overall StudyCOMPLETEDOcriplasmin 125µg235
Overall StudyCOMPLETEDPlacebo74
Overall StudyNOT COMPLETEDOcriplasmin 125µg10
Overall StudyNOT COMPLETEDPlacebo7

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherVitreous floatersEye disordersOcriplasmin 125ug3824540
otherVitreous floatersEye disordersPlacebo6818
otherConjuctival haemorrahgeEye disordersOcriplasmin 125ug3424534
otherConjuctival haemorrahgeEye disordersPlacebo108110
otherEye painEye disordersOcriplasmin 125ug3024533
otherEye painEye disordersPlacebo5815
otherPhotopsiaEye disordersOcriplasmin 125ug1924521
otherPhotopsiaEye disordersPlacebo1811
otherVision blurredEye disordersOcriplasmin 125ug1724518
otherVision blurredEye disordersPlacebo3813

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityOcriplasmin 125ug
Total, all-cause mortalityPlacebo
Total, other adverse eventsOcriplasmin 125ug105245
Total, other adverse eventsPlacebo2281
Total, serious adverse eventsOcriplasmin 125ug33245
Total, serious adverse eventsPlacebo1181

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
22879421DERIVEDPubMed
22894573DERIVEDPubMed
23033391DERIVEDPubMed
26068086DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Ocriplasmin 125ug vs Placebo: serious adverse events

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00798317

GET https://conductscience.org/api/trials/v1/NCT00798317/events?page=2