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

Phase 2TerminatedNCT00348439

Bausch & Lomb Incorporated29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Vitreoretinal Traction Syndrome

Interventions

PlasminDRUG

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

VehicleDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Emory University

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Presence of a Grade A Posterior Vitreous Detachment (PVD)

PVD at the disc and macula post plamin injection

Time frame: 14 Days

Data from ClinicalTrials.gov

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