Back to resultsStudy to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
Primary Purpose
Vitreoretinal Traction Syndrome
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plasmin
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Vitreoretinal Traction Syndrome
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.
Sites / Locations
- Emory University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Plasmin Injection
Vehicle
Arm Description
human-derived plasmin
Plasmin formulation, without active ingredient.
Outcomes
Primary Outcome Measures
Presence of a Grade A Posterior Vitreous Detachment (PVD)
PVD at the disc and macula post plamin injection
Secondary Outcome Measures
Full Information
NCT ID
NCT00348439
First Posted
June 30, 2006
Last Updated
June 20, 2019
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00348439
Brief Title
Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
Official Title
A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response 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
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 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. The pharmacological creation of a posterior vitreous detachment may be beneficial in 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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasmin Injection
Arm Type
Experimental
Arm Description
human-derived plasmin
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Plasmin formulation, without active ingredient.
Intervention Type
Drug
Intervention Name(s)
Plasmin
Intervention Description
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
Primary Outcome Measure Information:
Title
Presence of a Grade A Posterior Vitreous Detachment (PVD)
Description
PVD at the disc and macula post plamin injection
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 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.
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
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