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

Vitreoretinal Traction Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00347646
• Other study ID #: 484
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: September 2006
• Est. completion date: June 2007

Study information

• Verified date: June 2019
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitreoretinal Traction Syndrome
• Vitreous Detachment

Intervention

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

Locations

Country	Name	City	State
United States	University Hospitals of Cleveland	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a Posterior Vitreous Detachment (PVD)	Presence of posterior vitreous detachment evaluated durning virectomy	14 days