NCT00347646TerminatedPhase 1
An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)
Bausch & Lomb Incorporated1 site in 1 country4 target enrollmentStarted: September 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Presence of a Posterior Vitreous Detachment (PVD)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Plasmin
Experimental
Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.
Intervention: Plasmin (Drug)
Outcomes
Primary Outcomes
Presence of a Posterior Vitreous Detachment (PVD)
Time Frame: 14 days
Presence of posterior vitreous detachment evaluated durning virectomy
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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