Back to resultsA 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
About this trial
This is an interventional treatment trial for Vitreoretinal Traction Syndrome
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.
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
NCT ID
NCT00347646
First Posted
June 30, 2006
Last Updated
June 20, 2019
Sponsor
Bausch & Lomb Incorporated
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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