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: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2007
- 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
- Presence of a Posterior Vitreous Detachment (PVD)
- Time Frame: 14 days
- Presence of posterior vitreous detachment evaluated durning virectomy
Participating in This Clinical Trial
- Patients who are in need of a vitrectomy.
- 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
- Lead Sponsor
- Bausch & Lomb Incorporated
- Provider of Information About this Clinical Study
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