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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2007

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Plasmin Injection
    • human-derived plasmin
  • Placebo Comparator: Vehicle
    • Plasmin formulation, without active ingredient.

Clinical Trial Outcome Measures

Primary Measures

  • Presence of a Grade A Posterior Vitreous Detachment (PVD)
    • Time Frame: 14 Days
    • PVD at the disc and macula post plamin injection

Participating in This Clinical Trial

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.

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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