Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment

Phase 2

Terminated

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

• Registration Number: NCT00348439
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-30
• Study First Submitted QC: 2006-06-30
• Study First Posted: 2006-07-04
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Patients who would benefit from a posterior vitreous detachment, as determined by the evaluating ophthalmologist.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Plasmin formulation, without active ingredient.
Plasmin Injection	Plasmin	human-derived plasmin

Primary Outcome Measures

Name	Time	Method
Presence of a Grade A Posterior Vitreous Detachment (PVD)	14 Days	PVD at the disc and macula post plamin injection

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States