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

This study has been terminated.

First Received: June 30, 2006 Last Updated: May 12, 2008 History of Changes

Sponsored by:	Bausch & Lomb, Inc.
Information provided by:	Bausch & Lomb, Inc.
ClinicalTrials.gov Identifier:	NCT00348439

Purpose

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	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Drug Information available for: Fibrinolysin, human

U.S. FDA Resources

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

Study Start Date:	May 2006
Study Completion Date:	August 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 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 ClinicalTrials.gov identifier: NCT00348439

Locations

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Bausch & Lomb, Inc.

More Information

No publications provided

Responsible Party:	Bausch & Lomb, Inc. ( Marcia de Souza Lima )
Study ID Numbers:	437
Study First Received:	June 30, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00348439 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Plasmin
Fibrin Modulating Agents
Vitreous Detachment

Eye Diseases
Fibrinolytic Agents
Cardiovascular Agents

Additional relevant MeSH terms:

Plasmin
Fibrin Modulating Agents
Vitreous Detachment
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Eye Diseases
Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009