A Retrospective Chart Review of Patients Treated With Ocriplasmin for Symptomatic VMA (OZONE)

July 8, 2015 updated by: ThromboGenics

OZONE: Ocriplasmin Ellipsoid Zone Retrospective Data Collection Study

The purpose of this study is to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of symptomatic vitreomacular adhesion (VMA) with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This study (TG-MV-022) is a retrospective study utilizing Spectral-domain optical coherence tomography (SD-OCT) in patients treated previously with JETREA® for VMA. The objectives of this study are to retrospectively review and further characterize anatomic and symptomatic changes over six months immediately following treatment of VMA with JETREA® (ocriplasmin), including incidence, time to onset and resolution of anatomy and symptoms. The retrospective study will collect Heidelberg Spectralis® SD-OCT images which will be masked and uploaded to a Central Reading Center (CRC) for review and analysis. The CRC will evaluate anatomic endpoints of interest from both baseline optical coherence tomography (OCT) images and all follow-up OCT scans over the 6 month follow up period. Endpoints of interest include ellipsoid zone disruption, development of subretinal fluid, resolution of VMA and macular hole changes. Further, trained clinical personnel at the participating centers will transcribe data from the patients' records, to be entered into the study database.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

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
    • California
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Florida
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of Florida
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Eye Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush university medical center-Dept ophthalmology
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Sabates Eye Centers
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Carl W. Baker
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Boston, Massachusetts, United States, 02215
        • Harvard Vanguard Medical Associates
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • EyeSight Ophthalmic Services
    • New York
      • New York, New York, United States, 10021
        • MaculaCare
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Southeastern Retina Associates, P.C.
    • Texas
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • Plano, Texas, United States, 75075
        • Retina Specialists
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah, P.C.
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Eye Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who have been treated with JETREA® for Symptomatic vitreomacular adhesion (VMA)

Description

Inclusion Criteria:

  1. Must be at least 18 years of age or older.
  2. Have been treated with JETREA® for vitreomacular adhesion (VMA) between April 1, 2013 and December 31, 2013 with at least six months of follow up visits post injection. Note: If a patient's second eye was treated, only the first eye treated is eligible for study participation.
  3. Have been imaged with Heidelberg Spectralis SD-OCT at least one time within 30 days prior to JETREA® injection.
  4. Have been imaged with Heidelberg Spectralis SD-OCT at least two times post JETREA® injection with at least one scan between Days 1-21 and the second scan within six months,, including a corresponding visual acuity (VA).
  5. Be willing and able to provide informed consent.

Exclusion Criteria:

  1. Patients treated with JETREA® for medical conditions outside of the product label.

  2. Patients with other retinal conditions that affect the vitreo-retinal interface, or can lead to retinal atrophy, including but not limited to:

    • Neovascular age-related macular degeneration;
    • Fibrovascular scar;
    • Diabetic macular edema; and
    • Proliferative diabetic retinopathy.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with ellipsoid zone disruption by Day 21 post-JETREA® injection, determined by a Central Reading Center (CRC), that was not present at baseline.
Time Frame: Day 21
Day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with ellipsoid zone disruption, not present at baseline
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients with ellipsoid zone disruption with resolution
Time Frame: Up to 6 months
Up to 6 months
Time to onset of ellipsoid zone disruption
Time Frame: Up to 6 months
Up to 6 months
Time to resolution of ellipsoid zone disruption
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients that developed subretinal fluid, not present at baseline
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients that developed subretinal fluid with resolution
Time Frame: Up to 6 months
Up to 6 months
Time to onset of subretinal fluid
Time Frame: Up to 6 months
Up to 6 months
Time to resolution of subretinal fluid
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients with nonsurgical resolution of VMA by Day 28
Time Frame: Day 28
Day 28
Time to resolution of VMA
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients that developed a macular hole by Day 28, not present at baseline
Time Frame: Day 28
Day 28
Proportion of patients with nonsurgical closure of macular hole, if present at baseline by Day 28
Time Frame: Day 28
Day 28
Proportion of patients with worsening (enlargement) of macular hole, if present at baseline
Time Frame: Up to 6 months
Up to 6 months
No change of macular hole, if present at baseline
Time Frame: Up to 6 months
Up to 6 months
Proportion of patients that underwent vitrectomy
Time Frame: Up to 6 months
Up to 6 months
Visual Acuity (VA) changes from baseline
Time Frame: Up to 6 months
Up to 6 months
Other findings as examined and documented in the patient's medical records
Time Frame: Up to 6 months
  • Impaired pupillary reflex
  • Dyschromatopsia
  • ERG changes
  • Vascular changes
  • Visual field constriction
  • Lens changes post- JETREA® injection including, subluxation, dislocation, phacodenesis
  • Other changes in quality of vision including, darkness of vision, dark adaptation changes
Up to 6 months
Monitoring of Adverse Drug Reactions (ADRs)
Time Frame: Up to 6 motnths
Up to 6 motnths

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ThromboGenics

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TG-MV-022

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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