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

Primary Purpose

Vitreoretinal Traction Syndrome

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Plasmin
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreoretinal Traction Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals of Cleveland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Plasmin

Arm Description

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

Outcomes

Primary Outcome Measures

Presence of a Posterior Vitreous Detachment (PVD)
Presence of posterior vitreous detachment evaluated durning virectomy

Secondary Outcome Measures

Full Information

First Posted
June 30, 2006
Last Updated
June 20, 2019
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00347646
Brief Title
A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Official Title
An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of Efficacy
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreoretinal Traction Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plasmin
Arm Type
Experimental
Arm Description
Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.
Intervention Type
Drug
Intervention Name(s)
Plasmin
Intervention Description
27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection
Primary Outcome Measure Information:
Title
Presence of a Posterior Vitreous Detachment (PVD)
Description
Presence of posterior vitreous detachment evaluated durning virectomy
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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