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

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

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-08-31

Brief Summary

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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.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Plasmin Injection

human-derived plasmin

Group Type EXPERIMENTAL

Plasmin

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.

Interventions

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Plasmin

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

Intervention Type DRUG

Vehicle

Plasmin formulation, without active ingredient to be reconstituted in 0.9% Sterile Sodium Chloride and administered in a single intravitreal injection.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No