A Study to Evaluate Plasmin for the Creation of a Posteri... | NCT00347646

Studies
A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

NCT00347646

Sponsor

Bausch & Lomb Incorporated

Status

Terminated

Last Update Posted

Jun 21, 2019Actual

Enrollment

4Actual

Phase

Phase 1Phase 2

Conditions

Vitreoretinal Traction Syndrome

Interventions

Plasmin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of Efficacy

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

May 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2019

Last Update Posted Date

Jun 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plasmin	Experimental	Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.	Drug: Plasmin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasmin	Drug	27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection	Plasmin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of a Posterior Vitreous Detachment (PVD)	Presence of posterior vitreous detachment evaluated durning virectomy	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are in need of a vitrectomy.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of Cleveland		Cleveland	Ohio	44106	United States

Intervention Browse Module

MeSH Terms

ID	Term
D005341	Fibrinolysin

Ancestor Terms

ID	Term
D012697	Serine Endopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided