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

Bausch + Lomb

Status and phase: Terminated; Phase 2

Conditions: Vitreoretinal Traction Syndrome

Treatments: Drug: Plasmin; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348439

437

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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29 participants in 2 patient groups, including a placebo group

Plasmin Injection

Experimental group

Description:

human-derived plasmin

Treatment:

Drug: Plasmin

Vehicle

Placebo Comparator group

Description:

Plasmin formulation, without active ingredient.

Treatment:

Drug: Vehicle