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

NCT ID: NCT00412958

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

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-10-31

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 in patients undergoing surgical vitrectomy.

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.

Vitrectomy

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 25µg

25µg of ocriplasmin intravitreal injection

Group Type EXPERIMENTAL

Ocriplasmin 25µg

Intervention Type DRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.

Ocriplasmin 75µg

75µg of ocriplasmin intravitreal injection

Group Type EXPERIMENTAL

Ocriplasmin 75µg

Intervention Type DRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.

Ocriplasmin 125µg

125µg of ocriplasmin intravitreal injection

Group Type EXPERIMENTAL

Ocriplasmin 125µg

Intervention Type DRUG

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.

Placebo

Intravitreal injection of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Intravitreal injection of placebo

Interventions

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

Ocriplasmin 25µg

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.

Intervention Type DRUG

Ocriplasmin 75µg

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.

Intervention Type DRUG

Ocriplasmin 125µg

Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.

Intervention Type DRUG

Placebo

Intravitreal injection of placebo

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 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
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.

Retina Centers, P.C.

Tucson, Arizona, United States

Site Status

VMR Institute

Huntington Beach, California, United States

Site Status

Jules Stein Eye Institute/UCLA

Los Angeles, California, United States

Site Status

Retinal Consultants of San Diego

Poway, California, United States

Site Status

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status

National Ophtlamic Research Institute

Fort Meyers, Florida, United States

Site Status

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status

Rush University Med. Ctr

Chicago, Illinois, United States

Site Status

Mailing add: New England Eye Center - Tufts

Boston, Massachusetts, United States

Site Status

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Site Status

Vitroretinal Surgery, PA

Minneapolis, Minnesota, United States

Site Status

Retina Vitreous Centre, PA

New Brunswick, New Jersey, United States

Site Status

Columbia University - Harkness Eye Institute

New York, New York, United States

Site Status

Retina Vitreous Surgeons of Central NY

New York, New York, United States

Site Status

Duke Eye Center

Durham, North Carolina, United States

Site Status

Retina Association of Cleveland

Lakewood, Ohio, United States

Site Status

Allegheny Ophthalmic & Orbital Associates, P.C.

Pittsburgh, Pennsylvania, United States

Site Status

Vanderbilt Eye Institute

Nashville, Tennessee, United States

Site Status

Vitreoretinal Consultants

Houston, Texas, United States

Site Status

Valley Retina Institute, P.A.

McAllen, Texas, United States

Site Status

Countries

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

United States

Other Identifiers

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

TG-MV-003

Identifier Type: -

Identifier Source: org_study_id