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

This study has been terminated.
(Lack of Efficacy)
Information provided by (Responsible Party):
Bausch & Lomb Incorporated Identifier:
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011

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.

Condition Intervention Phase
Disorders Caused by Vitreo-retinal Traction.
Drug: Plasmin
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Presence of a Grade A Posterior Vitreous Detachment (PVD) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    PVD at the disc and macula post plamin injection

Enrollment: 29
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plasmin Injection
human-derived plasmin
Drug: Plasmin
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
Placebo Comparator: Vehicle
Plasmin formulation, without active ingredient.
Drug: Vehicle
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00348439

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT00348439     History of Changes
Other Study ID Numbers: 437
Study First Received: June 30, 2006
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vitreous Detachment
Eye Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents processed this record on April 21, 2014