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

This study has been terminated.

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00347646

Purpose

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.

Condition	Intervention	Phase
Disorders Caused by Vitreo-Retinal Traction.	Drug: Plasmin	Phase II

Drug Information available for: Fibrinolysin, human

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Bausch & Lomb, Inc.:

Study Start Date:	September 2006
Study Completion Date:	May 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347646

Locations

United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States

Sponsors and Collaborators

Bausch & Lomb, Inc.

More Information

Responsible Party:	Bausch & Lomb, Inc. ( Marcia de Souza Lima )
Study ID Numbers:	484
Study First Received:	June 30, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00347646
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Plasmin
Vitreous Detachment
Eye Diseases

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009