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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

June 30, 2006
July 4, 2006
December 8, 2011
April 2006
August 2007   (Final data collection date for primary outcome measure)
Presence of a Grade A Posterior Vitreous Detachment (PVD) [ Time Frame: 14 Days ]
PVD at the disc and macula post plamin injection
Not Provided
Complete list of historical versions of study NCT00348439 on ClinicalTrials.gov Archive Site
Not Provided
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Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment
A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Disorders Caused by Vitreo-retinal Traction.
  • Drug: Plasmin
    27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
  • Drug: Vehicle
    Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.
  • Experimental: Plasmin Injection
    human-derived plasmin
    Intervention: Drug: Plasmin
  • Placebo Comparator: Vehicle
    Plasmin formulation, without active ingredient.
    Intervention: Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
29
Not Provided
August 2007
August 2007   (Final data collection date for primary outcome measure)

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.
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
 
 
NCT00348439
437
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