MedDataX Logo

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

NCT ID: NCT00435539

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitreomacular Traction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

VMT PVD Vitreomacular Traction Maculopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ocriplasmin 75µg single injection

Ocriplasmin 75µg single injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

ocriplasmin 125µg single injection

Ocriplasmin 125µg single injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

ocriplasmin 175µg single injection

Ocriplasmin 175µg single injection versus sham injection

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

ocriplasmin 125µg multiple injections

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.

Group Type EXPERIMENTAL

ocriplasmin

Intervention Type DRUG

Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.

sham injection

sham injection

Group Type SHAM_COMPARATOR

Sham Comparator

Intervention Type DRUG

Intravitreal sham injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ocriplasmin

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

Intervention Type DRUG

ocriplasmin

Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval.

Intervention Type DRUG

Sham Comparator

Intravitreal sham injection

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

microplasmin microplasmin microplasmin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ThromboGenics

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

ZNA OCMW Antwerpen

Antwerp, , Belgium

Site Status

University Hospital of Ghent

Ghent, , Belgium

Site Status

Universitaire Ziekenhuizen K.U.Leuven

Leuven, , Belgium

Site Status

Augenklinik der Universitat Munchen

München, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ireland Belgium Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MIVI-IIT

Identifier Type: -

Identifier Source: secondary_id

TG-MV-004

Identifier Type: -

Identifier Source: org_study_id