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Completed

NCT Number: NCT00412958

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

A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.

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Key information

Conditions

Vitrectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retina Centers, P.C., Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ocriplasmin 25µg

Drug

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

Other names: Microplasmin

Ocriplasmin 75µg

Drug

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

Other names: Microplasmin

Ocriplasmin 125µg

Drug

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

Other names: Microplasmin

Placebo

Drug

Intravitreal injection of placebo

Primary outcomes

  1. Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect

    Time frame: Day 7

    The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 19, 2006
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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