NCT00347646

Brief Summary

Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a variety of conditions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2006

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

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
2 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

June 30, 2006

Last Update Submit

June 20, 2019

Conditions

Vitreoretinal Traction Syndrome

Outcome Measures

Primary Outcomes (1)

  • Presence of a Posterior Vitreous Detachment (PVD)

    Presence of posterior vitreous detachment evaluated durning virectomy

    14 days

Study Arms (1)

Plasmin

EXPERIMENTAL

Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.

Drug: Plasmin

Interventions

PlasminDRUG

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

Plasmin

Eligibility Criteria

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

You may qualify if:

  • Patients who are in need of a vitrectomy.

You may not qualify if:

  • A PVD in the study eye as assessed by the investigator using ophthalmic and alternative examination techniques.
  • A history of vitrectomy in the study eye.
  • A media opacity that precludes quality examination of the vitreous and fundus in the study eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Fibrinolysin

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine Proteases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

September 1, 2006

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

June 21, 2019

Record last verified: 2019-06

Locations

US(1)