A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Vitreomacular Traction

Treatments: Drug: Sham Comparator; Drug: ocriplasmin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435539

TG-MV-004

MIVI-IIT

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 vitreomacular traction.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >_ 18 years of age with vitreomacular traction

Exclusion criteria

• PVD present at baseline
• Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
• Vitreous hemorrhage
• 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: Double Blind

---

60 participants in 5 patient groups

ocriplasmin 75µg single injection

Experimental group

Description:

Ocriplasmin 75µg single injection versus sham injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

ocriplasmin 125µg single injection

Experimental group

Description:

Ocriplasmin 125µg single injection versus sham injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

ocriplasmin 175µg single injection

Experimental group

Description:

Ocriplasmin 175µg single injection versus sham injection

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

ocriplasmin 125µg multiple injections

Experimental group

Description:

Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg.

Treatment:

Drug: ocriplasmin

Drug: ocriplasmin

sham injection

Sham Comparator group

Description:

sham injection

Treatment:

Drug: Sham Comparator