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

Phase 1

Terminated

• Conditions: Vitreoretinal Traction Syndrome
• Interventions: Drug: Plasmin

• Registration Number: NCT00347646
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Study Start: 2006-09
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Plasmin	Plasmin	Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.

Primary Outcome Measures

Name	Time	Method
Presence of a Posterior Vitreous Detachment (PVD)	14 days	Presence of posterior vitreous detachment evaluated durning virectomy

Trial Locations

Locations (1)

University Hospitals of Cleveland; 🇺🇸 Cleveland, Ohio, United States