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
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Presence of a Posterior Vitreous Detachment (PVD) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Presence of posterior vitreous detachment evaluated durning virectomy


Enrollment: 4
Study Start Date: September 2006
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Plasmin
Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.
Drug: Plasmin
27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00347646     History of Changes
Other Study ID Numbers: 484
Study First Received: June 30, 2006
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vitreous Detachment
Eye Diseases
Fibrinolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on September 16, 2014