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

Study Overview
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Brief Summary
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A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

Official Title
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A Randomized, Sham-Injection Controlled, Double-Masked, Ascending-Dose, Dose-Range-Finding Trial of Microplasmin Intravitreal Injection for Non-Surgical Posterior Vitreous Detachment (PVD) Induction for Treatment of Vitreomacular Traction (VMT).

Conditions
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Vitreomacular Traction

Intervention / Treatment
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* Drug: ocriplasmin
* Drug: ocriplasmin
* Drug: Sham Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ocriplasmin 75µg single injection<br>Ocriplasmin 75µg single injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.<br>* Other names: microplasmin;|
| Experimental: ocriplasmin 125µg single injection<br>Ocriplasmin 125µg single injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.<br>* Other names: microplasmin;|
| Experimental: ocriplasmin 175µg single injection<br>Ocriplasmin 175µg single injection versus sham injection | Drug: ocriplasmin<br>* Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.<br>* Other names: microplasmin;|
| Experimental: ocriplasmin 125µg multiple injections<br>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. | Drug: ocriplasmin<br>* Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.<br>* Other names: microplasmin;|
| Sham Comparator: sham injection<br>sham injection | Drug: Sham Comparator<br>* Intravitreal sham injection<br>* Other names: microplasmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Vitreomacular Traction (Investigator's Assessment) | Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitreomacular Traction, Maculopathy, VMT, PVD