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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:
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

June 30, 2006
December 7, 2011
September 2006
May 2007   (final data collection date for primary outcome measure)
Presence of a Posterior Vitreous Detachment (PVD) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00347646
484
Yes
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