A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME) (MIVI-II)

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Other: Sham injection; Drug: ocriplasmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00412451

TG-MV-002

Details and patient eligibility

About

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria include:

• patients >18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 4 patient groups

Ocriplasmin 25µg

Experimental group

Description:

25µg ocriplasmin intravitreal injection versus sham injection

Treatment:

Drug: ocriplasmin

Ocriplasmin 75µg

Experimental group

Description:

75µg ocriplasmin intravitreal injection versus sham injection

Treatment:

Drug: ocriplasmin

Ocriplasmin 125µg

Experimental group

Description:

125µg ocriplasmin intravitreal injection versus sham injection

Treatment:

Drug: ocriplasmin

sham injection

Sham Comparator group

Description:

Sham injection

Treatment:

Other: Sham injection