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

This study has been terminated.

(Lack of Efficacy)

Sponsor:

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

ClinicalTrials.gov Identifier:

NCT00347646

First received: June 30, 2006

Last updated: December 7, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 30, 2006
Last Updated Date	December 7, 2011
Start Date ^ICMJE	September 2006
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 12, 2010)	Presence of a Posterior Vitreous Detachment (PVD) [ Time Frame: 14 days ] [ Designated as safety issue: No ] Presence of posterior vitreous detachment evaluated durning virectomy
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00347646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Official Title ^ICMJE	An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Disorders Caused by Vitreo-retinal Traction.
Intervention ^ICMJE	Drug: Plasmin 27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection
Study Arm (s)	Experimental: Plasmin Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection. Intervention: Drug: Plasmin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	4
Completion Date	June 2007
Primary Completion Date	May 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00347646
Other Study ID Numbers ^ICMJE	484
Has Data Monitoring Committee	Yes
Responsible Party	Bausch & Lomb Incorporated
Study Sponsor ^ICMJE	Bausch & Lomb Incorporated
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bausch & Lomb Incorporated
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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