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

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ClinicalTrials.gov Identifier: NCT00348439
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : July 4, 2006
Last Update Posted : December 8, 2011
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Disorders Caused by Vitreo-retinal Traction. Drug: Plasmin Drug: Vehicle Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Study Start Date : April 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Arm Intervention/treatment
Experimental: Plasmin Injection
human-derived plasmin
Drug: Plasmin
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.

Placebo Comparator: Vehicle
Plasmin formulation, without active ingredient.
Drug: Vehicle
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.




Primary Outcome Measures :
  1. Presence of a Grade A Posterior Vitreous Detachment (PVD) [ Time Frame: 14 Days ]
    PVD at the disc and macula post plamin injection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348439


Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Bausch & Lomb Incorporated

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348439     History of Changes
Other Study ID Numbers: 437
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011

Additional relevant MeSH terms:
Vitreous Detachment
Eye Diseases
Fibrinolysin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action