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Study 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
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 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

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
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

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

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