A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Vitrectomy

Treatments: Drug: Ocriplasmin 25µg; Drug: Placebo; Drug: Ocriplasmin 125µg; Drug: Ocriplasmin 75µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412958

TG-MV-003

Details and patient eligibility

About

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in whom vitrectomy is indicated

Exclusion criteria

• Posterior Vitreous Detachment (PVD) present at baseline
• Vitreous hemorrhage
• Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
• Have had a vitrectomy in the study eye at any time

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 4 patient groups, including a placebo group

Ocriplasmin 25µg

Experimental group

Description:

25µg of ocriplasmin intravitreal injection

Treatment:

Drug: Ocriplasmin 25µg

Ocriplasmin 75µg

Experimental group

Description:

75µg of ocriplasmin intravitreal injection

Treatment:

Drug: Ocriplasmin 75µg

Ocriplasmin 125µg

Experimental group

Description:

125µg of ocriplasmin intravitreal injection

Treatment:

Drug: Ocriplasmin 125µg

Placebo

Placebo Comparator group

Description:

Intravitreal injection of placebo

Treatment:

Drug: Placebo