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

Vitreoretinal Traction Syndrome Clinical Trial

Official title:

A Multicenter, Randomized, Double Masked, Placebo Controlled, Sequential Dose Response Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00348439
• Other study ID #: 437
• Status: Terminated
• Phase: Phase 2
• Start date: April 2006
• Est. completion date: August 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. The pharmacological creation of a posterior vitreous detachment may be beneficial in a variety of conditions.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitreoretinal Traction Syndrome
• Vitreous Detachment

Intervention

Drug:
• Plasmin
27 mg of human-derived plasmin to be reconstituted with 0.9% Sterile Sodium Chloride for a single intravitreal injection.
• Vehicle
Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

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 Grade A Posterior Vitreous Detachment (PVD)	PVD at the disc and macula post plamin injection	14 Days