Study to Evaluate Plasmin for the Creation of a Posterior... | NCT00348439

Studies
Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment

NCT00348439

Sponsor

Bausch & Lomb Incorporated

Status

Terminated

Last Update Posted

Jun 21, 2019Actual

Enrollment

29Actual

Phase

Phase 2

Conditions

Vitreoretinal Traction Syndrome

Interventions

Plasmin
Vehicle

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

Apr 2006

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 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. The pharmacological creation of a posterior vitreous detachment may be beneficial in 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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plasmin Injection	Experimental	human-derived plasmin	Drug: Plasmin
Vehicle	Placebo Comparator	Plasmin formulation, without active ingredient.	Drug: Vehicle

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of a Grade A Posterior Vitreous Detachment (PVD)	PVD at the disc and macula post plamin injection	14 Days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

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
Emory University		Atlanta	Georgia	30322	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