NCT00435539

Brief Summary

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2007

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

September 13, 2013

Completed
Last Updated

December 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.9 years

First QC Date

February 14, 2007

Results QC Date

July 4, 2013

Last Update Submit

December 2, 2014

Conditions

Vitreomacular Traction

Keywords

Vitreomacular TractionMaculopathyVMTPVD

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging.

    Day 14

Secondary Outcomes (1)

  • Resolution of Vitreomacular Traction (Investigator's Assessment)

    Day 28

Study Arms (5)

ocriplasmin 75µg single injection

EXPERIMENTAL

Ocriplasmin 75µg single injection versus sham injection

Drug: ocriplasmin

ocriplasmin 125µg single injection

EXPERIMENTAL

Ocriplasmin 125µg single injection versus sham injection

Drug: ocriplasmin

ocriplasmin 175µg single injection

EXPERIMENTAL

Ocriplasmin 175µg single injection versus sham injection

Drug: ocriplasmin

ocriplasmin 125µg multiple injections

EXPERIMENTAL

Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.

Drug: ocriplasmin

sham injection

SHAM COMPARATOR

sham injection

Drug: Sham Comparator

Interventions

ocriplasminDRUG

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

Also known as: microplasmin
ocriplasmin 125µg single injectionocriplasmin 175µg single injectionocriplasmin 75µg single injection
Sham ComparatorDRUG

Intravitreal sham injection

Also known as: microplasmin
sham injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>\_ 18 years of age with vitreomacular traction

You may not qualify if:

  • PVD present at baseline
  • Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
  • Vitreous hemorrhage
  • Patients who have had a vitrectomy in the study eye at any time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

ZNA OCMW Antwerpen

Antwerp, 2020, Belgium

Location

University Hospital of Ghent

Ghent, B-9000, Belgium

Location

Universitaire Ziekenhuizen K.U.Leuven

Leuven, Belgium

Location

Augenklinik der Universitat Munchen

München, 80336, Germany

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

microplasmin

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Results Point of Contact

Title
Petra Kozma-Wiebe, MD
Organization
ThromboGenics
petra.kozma@thrombogenics.com
+32 16751310

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2007

First Posted

February 15, 2007

Study Start

February 1, 2007

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

December 17, 2014

Results First Posted

September 13, 2013

Record last verified: 2014-04

Locations

BE(3)DE(1)