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Completed

NCT Number: NCT00435539

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

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

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Key information

Conditions

Vitreomacular Traction Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ZNA OCMW Antwerpen, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ocriplasmin

Drug

Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin.

Other names: microplasmin

Sham Comparator

Drug

Intravitreal sham injection

Other names: microplasmin

Primary outcomes

  1. 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.

    Time frame: Day 14

Secondary outcomes

  1. Resolution of Vitreomacular Traction (Investigator's Assessment)

    Time frame: Day 28

    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.

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study title

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).

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2007
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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