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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitreoretinal Traction Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plasmin

Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.

Group Type EXPERIMENTAL

Plasmin

Intervention Type DRUG

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

Interventions

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Plasmin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No