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

This study has been terminated.
(Lack of Efficacy)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00347646
First Posted: July 4, 2006
Last Update Posted: December 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
June 30, 2006
July 4, 2006
December 9, 2011
September 2006
May 2007   (Final data collection date for primary outcome measure)
Presence of a Posterior Vitreous Detachment (PVD) [ Time Frame: 14 days ]
Presence of posterior vitreous detachment evaluated durning virectomy
Not Provided
Complete list of historical versions of study NCT00347646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
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.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Disorders Caused by Vitreo-retinal Traction.
Drug: Plasmin
27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection
Experimental: Plasmin
Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.
Intervention: Drug: Plasmin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
June 2007
May 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00347646
484
Yes
Not Provided
Not Provided
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Not Provided
Bausch & Lomb Incorporated
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP