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

This study has been terminated.
(Lack of Efficacy)
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00348439
First received: June 30, 2006
Last updated: December 7, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Disorders Caused by Vitreo-retinal Traction.
Drug: Plasmin
Drug: Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Presence of a Grade A Posterior Vitreous Detachment (PVD) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    PVD at the disc and macula post plamin injection


Enrollment: 29
Study Start Date: April 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00348439

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00348439     History of Changes
Other Study ID Numbers: 437
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 August 28, 2014