A Study to Evaluate Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

June 20, 2019 updated by: Bausch & Lomb Incorporated

An Open Label Sequential Dose Response Observational Study of Intravitreally Administered Plasmin for the Creation of a Posterior Vitreous Detachment (PVD)

Plasmin is expected to create a posterior vitreous detachment (PVD) when injected directly into the eye. The pharmacological creation of a PVD may be beneficial in helping to treat a variety of conditions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are in need of a vitrectomy.

Exclusion Criteria:

  • A PVD in the study eye as assessed by the investigator using ophthalmic and alternative examination techniques.
  • A history of vitrectomy in the study eye.
  • A media opacity that precludes quality examination of the vitreous and fundus in the study eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Plasmin
Human-derived plasmin reconstituted with sterile sodium chloride for intravitreal injection.
Drug: Plasmin
27 mg of human-derived plasmin to be reconstituted with of 0.9% Sterile Sodium Chloride for a single intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of a Posterior Vitreous Detachment (PVD)
Time Frame: 14 days
Presence of posterior vitreous detachment evaluated durning virectomy
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

May 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (ESTIMATE)

July 4, 2006

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 20, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 484

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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