A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Overview

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.

Full Title of Study: “An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2007

Interventions

  • Drug: Plasmin
    • 27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection

Arms, Groups and Cohorts

  • Experimental: Plasmin
    • Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.

Clinical Trial Outcome Measures

Primary Measures

  • Presence of a Posterior Vitreous Detachment (PVD)
    • Time Frame: 14 days
    • Presence of posterior vitreous detachment evaluated durning virectomy

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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