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: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2007
- 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
- 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
- Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.
- 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
- Lead Sponsor
- Bausch & Lomb Incorporated
- Provider of Information About this Clinical Study
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