NCT00412958

Brief Summary

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

20 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

December 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

January 30, 2013

Completed
Last Updated

December 17, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

December 18, 2006

Results QC Date

December 20, 2012

Last Update Submit

December 2, 2014

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect

    The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.

    Day 7

Study Arms (4)

Ocriplasmin 25µg

EXPERIMENTAL

25µg of ocriplasmin intravitreal injection

Drug: Ocriplasmin 25µg

Ocriplasmin 75µg

EXPERIMENTAL

75µg of ocriplasmin intravitreal injection

Drug: Ocriplasmin 75µg

Ocriplasmin 125µg

EXPERIMENTAL

125µg of ocriplasmin intravitreal injection

Drug: Ocriplasmin 125µg

Placebo

PLACEBO COMPARATOR

Intravitreal injection of placebo

Drug: Placebo

Interventions

Ocriplasmin 25µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.

Also known as: Microplasmin
Ocriplasmin 25µg
Ocriplasmin 75µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.

Also known as: Microplasmin
Ocriplasmin 75µg
Ocriplasmin 125µgDRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.

Also known as: Microplasmin
Ocriplasmin 125µg
PlaceboDRUG

Intravitreal injection of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients in whom vitrectomy is indicated

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Retina Centers, P.C.

Tucson, Arizona, 85704, United States

Location

VMR Institute

Huntington Beach, California, 92647, United States

Location

Jules Stein Eye Institute/UCLA

Los Angeles, California, 90095, United States

Location

Retinal Consultants of San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Medical Group

Sacramento, California, 95819, United States

Location

National Ophtlamic Research Institute

Fort Meyers, Florida, 33912, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Rush University Med. Ctr

Chicago, Illinois, 60612, United States

Location

Mailing add: New England Eye Center - Tufts

Boston, Massachusetts, 02111, United States

Location

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, 48073, United States

Location

Vitroretinal Surgery, PA

Minneapolis, Minnesota, 55435, United States

Location

Retina Vitreous Centre, PA

New Brunswick, New Jersey, 08901, United States

Location

Columbia University - Harkness Eye Institute

New York, New York, 10032, United States

Location

Retina Vitreous Surgeons of Central NY

New York, New York, 13224, United States

Location

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

Retina Association of Cleveland

Lakewood, Ohio, 44107, United States

Location

Allegheny Ophthalmic & Orbital Associates, P.C.

Pittsburgh, Pennsylvania, 15212, United States

Location

Vanderbilt Eye Institute

Nashville, Tennessee, 37232-8808, United States

Location

Vitreoretinal Consultants

Houston, Texas, 77030, United States

Location

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

Location

MeSH Terms

Interventions

microplasmin

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
GT60
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

December 18, 2006

First Posted

December 19, 2006

Study Start

December 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 17, 2014

Results First Posted

January 30, 2013

Record last verified: 2014-04

Locations

US(20)