Trial · NCT00412451

A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

NCT00412451, Phase 2, Completed, ThromboGenics; results first posted 2013-09-13

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME). Trials, record NCT00412451. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00412451

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Trial

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

Title: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)
NCT number: NCT00412451
Status: Completed
Phases: Phase 2
Enrollment: 51 participants, actual
Lead sponsor: ThromboGenics
Conditions: Diabetic Macular Edema
Interventions: ocriplasmin, Sham injection
First posted: 2006-12-18
Last updated: 2014-12-17
Results first posted: 2013-09-13

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	PVD Induction	Day 14 post-injection	The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT)

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	PVD Induction	Day 14 post-injection	Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF)	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
PVD Induction	Ocriplasmin 25µg	0	percentage of participants
PVD Induction	Ocriplasmin 75µg	20	percentage of participants
PVD Induction	Ocriplasmin 125µg	13.3	percentage of participants
PVD Induction	Sham Injection	30.8	percentage of participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ocriplasmin 25µg	8
Overall Study	STARTED	Ocriplasmin 75µg	15
Overall Study	STARTED	0criplasmin 125µg	15
Overall Study	STARTED	Sham Injection	13
Overall Study	COMPLETED	Ocriplasmin 25µg	8
Overall Study	COMPLETED	Ocriplasmin 75µg	15
Overall Study	COMPLETED	0criplasmin 125µg	14
Overall Study	COMPLETED	Sham Injection	11
Overall Study	NOT COMPLETED	Ocriplasmin 25µg	0
Overall Study	NOT COMPLETED	Ocriplasmin 75µg	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events144

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

Type	Event	Organ system	Group	Affected	At risk
other	Angina Pectoris	Cardiac disorders	Ocriplasmin 25µg	0	8
other	Angina Pectoris	Cardiac disorders	Ocriplasmin 75µg	0	15
other	Angina Pectoris	Cardiac disorders	Ocriplasmin 125µg	0	15
other	Angina Pectoris	Cardiac disorders	Sham Injection	1	13
other	Atrioventricular block complete	Cardiac disorders	Ocriplasmin 25µg	0	8
other	Atrioventricular block complete	Cardiac disorders	Ocriplasmin 75µg	0	15
other	Atrioventricular block complete	Cardiac disorders	Ocriplasmin 125µg	0	15
other	Atrioventricular block complete	Cardiac disorders	Sham Injection	1	13
other	Cardiac arrest	Cardiac disorders	Ocriplasmin 25µg	0	8
other	Cardiac arrest	Cardiac disorders	Ocriplasmin 75µg	0	15

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ocriplasmin 25µg
Total, all-cause mortality	Ocriplasmin 75µg
Total, all-cause mortality	Ocriplasmin 125µg
Total, all-cause mortality	Sham Injection
Total, other adverse events	Ocriplasmin 25µg	1	8
Total, other adverse events	Ocriplasmin 75µg	4	15
Total, other adverse events	Ocriplasmin 125µg	5	15
Total, other adverse events	Sham Injection	7	13
Total, serious adverse events	Ocriplasmin 25µg	1	8
Total, serious adverse events	Ocriplasmin 75µg	4	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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/NCT00412451

GET https://conductscience.org/api/trials/v1/NCT00412451/events?page=2

API reference For AI assistants