NCT00348439

Brief Summary

Plasmin is expected to create a posterior vitreous detachment. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

June 30, 2006

Last Update Submit

June 20, 2019

Conditions

Vitreoretinal Traction Syndrome

Outcome Measures

Primary Outcomes (1)

  • Presence of a Grade A Posterior Vitreous Detachment (PVD)

    PVD at the disc and macula post plamin injection

    14 Days

Study Arms (2)

Plasmin Injection

EXPERIMENTAL

human-derived plasmin

Drug: Plasmin

Vehicle

PLACEBO COMPARATOR

Plasmin formulation, without active ingredient.

Drug: Vehicle

Interventions

PlasminDRUG

27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.

Plasmin Injection
VehicleDRUG

Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.

Vehicle

Eligibility Criteria

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

You may qualify if:

  • Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.

You may not qualify if:

  • Presence of a posterior vitreous detachment in the study eye
  • History of vitrectomy in the study eye
  • Proliferative diabetic retinopathy in the study eye
  • Presence of media opacity that precludes quality examination of the vitreous and fundus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Fibrinolysin

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

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

June 30, 2006

First Posted

July 4, 2006

Study Start

April 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

June 21, 2019

Record last verified: 2019-06

Locations

US(1)