ConductScience.org, home

Trial · NCT00781859

Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.

NCT00781859, Phase 3, Completed, ThromboGenics; results first posted 2013-01-28

3 sourcestrials-2026-11-12-0.4.0

Download JSON
Cite this record

ConductScience Library. Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial. Trials, record NCT00781859. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00781859

On this page

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-006) Trial.
NCT number
NCT00781859
Status
Completed
Phases
Phase 3
Enrollment
326 participants, actual
Lead sponsor
ThromboGenics
Conditions
Vitreomacular Adhesion
Interventions
125 µg Ocriplasmin, Placebo
First posted
2008-10-29
Last updated
2014-12-17
Results first posted
2013-01-28

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 28.Day 28
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.
SecondaryProportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Day 28The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (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 28.Day 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 28.Ocriplasmin 125µg27.9percentage of participants
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.Placebo13.1percentage of participants
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Ocriplasmin 125µg16.4percentage of participants
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28Placebo6.5percentage of participants

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDOcriplasmin 125µg219
Overall StudySTARTEDPlacebo107
Overall StudyCOMPLETEDOcriplasmin 125µg200
Overall StudyCOMPLETEDPlacebo98
Overall StudyNOT COMPLETEDOcriplasmin 125µg19
Overall StudyNOT COMPLETEDPlacebo9

Adverse events56

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherVitreous floatersEye disordersOcriplasmin 125µg4422049
otherVitreous floatersEye disordersPlacebo1010610
otherConjunctival HemorrhageEye disordersOcriplasmin 125µg3422035
otherConjunctival HemorrhageEye disordersPlacebo1410614
otherPhotopsiaEye disordersOcriplasmin 125µg3722040
otherPhotopsiaEye disordersPlacebo41064
otherEye painEye disordersOcriplasmin 125µg3422039
otherEye painEye disordersPlacebo61066
otherVision blurredEye disordersOcriplasmin 125µg2522027
otherVision blurredEye disordersPlacebo51067

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityOcriplasmin 125µg
Total, all-cause mortalityPlacebo
Total, other adverse eventsOcriplasmin 125µg127220
Total, other adverse eventsPlacebo35106
Total, serious adverse eventsOcriplasmin 125µg32220
Total, serious adverse eventsPlacebo13106

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 125µg 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/NCT00781859

GET https://conductscience.org/api/trials/v1/NCT00781859/events?page=2