Ocriplasmin Research to Better Inform Treatment (ORBIT) (ORBIT)

June 20, 2016 updated by: ThromboGenics
This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

Study Overview

Status

Completed

Conditions

Detailed Description

The sites will prospectively enroll consecutive patients eligible for participation in the study. Informed consent will be obtained prior to any data being collected. This study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. Patients will be enrolled at a routinely scheduled visit, on the day of JETREA® administration after the JETREA® injection. No specific visits, examinations, laboratory tests or procedures are mandated as part of this study. There is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. All available and relevant data will be collected prospectively.

Study Type

Observational

Enrollment (Actual)

540

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
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Arizona
      • Phoenix, Arizona, United States, 85020
        • Associated Retina Consultants, Ltd
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Assciates Medical Group
      • Encino, California, United States, 91436
        • Valley Retina Institute, PA
      • Fresno, California, United States, 93720
        • California Eye Institute
      • La Jolla, California, United States, 92037
        • Scripps Clinic Torrey Pines
      • Laguna Hills, California, United States, 92653
        • Retina Associates of Orange County
      • Long Beach, California, United States, 90807-2008
        • South Coast Retina Center
      • Los Angeles, California, United States, 90032
        • University of Southern California Medical Center
      • Los Angeles, California, United States, 90095-7004
        • Jules Stein Eye Institute
      • Orange, California, United States, 92868
        • University of California at Irvine Medical Center
      • Palm Springs, California, United States, 92262
        • Southern California Desert Retina Specialists
      • Sacramento, California, United States, 95817
        • Lawrence J. Ellison Ambulatory Care Center - UC Health
      • San Jose, California, United States, 95116
        • Retinal Diagnostic Center
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical
      • Santa Barbara, California, United States, 93103
        • California Retina Consultants
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The GW Medical Faculty Associates
    • Florida
      • Miami, Florida, United States, 33126
        • Retina Macula Specialists of Miami
      • Miami, Florida, United States, 33143
        • MedEye Associates
      • Palm Beach Gardens, Florida, United States, 33418
        • Bascom-Palmer
      • Pensacola, Florida, United States, 32503-2030
        • Retina Specialty Institute
      • Sarasota, Florida, United States, 34239
        • Center For Sight
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
      • Sarasota, Florida, United States, 34233
        • Retina Associates of Sarasota
      • St. Petersburg, Florida, United States, 33711
        • Retina Vitreous Associates of FL
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida
      • Winter Haven, Florida, United States, 33880
        • Center for Retina & Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
      • Decatur, Georgia, United States, 30030
        • Georgia Retina
      • Marietta, Georgia, United States, 30060
        • Marietta Eye
    • Hawaii
      • Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii, Inc
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60601
        • Chicagoland Retinal Consultants
      • Chicago, Illinois, United States, 60612
        • Lions of Illinois Research Institute-Eye and Ear Infirmary
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates, P.C.
      • Springfield, Illinois, United States, 62704
        • Illinois Retina Center
      • Urbana, Illinois, United States, 61801
        • Carle Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Dr. Thomas Ciulla
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Kansas
      • Leawood, Kansas, United States, 66211
        • Sabates Eye Centers
      • Wichita, Kansas, United States, 67214
        • Vitreo-Retinal Consultants & Surgeons
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Retina Associates of Kentucky
      • Louisville, Kentucky, United States, 40292
        • Eye Specialists of Louisville, PSC
      • Paducah, Kentucky, United States, 42001
        • Carl W Baker
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Retina & Vitreous of Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Acadiana Retina Consultants
      • West Monroe, Louisiana, United States, 71291
        • Haik Humble Eye Center
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group, PA
      • Chevy Chase, Maryland, United States, 20815
        • The Retina Group of Washintong
      • Lutherville, Maryland, United States, 21093
        • Katzen Eye Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center, Inc.
      • Boston, Massachusetts, United States, 02215
        • Harvard Vanguard Medical Associates
      • Worcerster, Massachusetts, United States, 01605
        • Vitroretinal Assciates
      • Worcester, Massachusetts, United States, 01613
        • Central Mass Retina & Uveitis Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • Vitreo Retinal Surgery
    • Missouri
      • St. Louis, Missouri, United States, 63144
        • Barnes Retina Institute
    • Nebraska
      • OMaha, Nebraska, United States, 68198
        • niversity of Nebraska Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Retina Consultants of Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Eyesight Ophthalmic Services
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Retina Center of New Jersey, LLP
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley Retina Associates
      • New Brunswick, New Jersey, United States, 08901
        • NJ Retina
      • Northfield, New Jersey, United States, 08225
        • Retinal and Ophthalmic Consultants
      • Teaneck, New Jersey, United States, 07666
        • Retina Associates Of New Jersey, Pa
    • New York
      • Amsterdam, New York, United States, 12010
        • Kwiat Eye & Laser Surgery
      • Latham, New York, United States, 12110
        • Capital Retina Associates
      • Lynbrook, New York, United States, 11563
        • Ophthalmic Consultants of Long Island
      • New York, New York, United States, 10021
        • MaculaCare
      • New York, New York, United States, 10022
        • Vitreous-Retina-Macula Consultants of NY,PC
      • Shirley, New York, United States, 11967
        • Island Retina
      • Syracuse, New York, United States, 13224
        • Retina Vitreous Surgeons of Central NY
      • Wilton, New York, United States, 12831
        • Capital Region Retina
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Eye Center
      • Greenville, North Carolina, United States, 27834
        • East Carolina Retina Consultants
      • Raleigh, North Carolina, United States, 27607
        • North Carolina Retina Assoc
      • Wilmington, North Carolina, United States, 28401
        • Cape Fear Retina
      • Winston Salem, North Carolina, United States, 27103
        • Dr Mark Nelson
      • Winston-Salem, North Carolina, United States, 27103
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • Tri-State Centers for Sight
      • Cincinnati, Ohio, United States, 45227
        • Eye Care Associates of Greater Cincinnati, Inc.
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Middleburg Heights, Ohio, United States, 44130
        • Retina Associates of Cleveland
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center in Edmond Oklahoma
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011-1776
        • Pennsylvania Retina Specialists PC
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina
      • Pittsburgh, Pennsylvania, United States, 15122
        • Associates Ophthalmology and Associates Surgery Centers, LLC
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Ophthalmology and Orbital Associates
    • South Carolina
      • Charlestown, South Carolina, United States, 29414
        • Carolina Eyecare
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Southeastern Retina Associates
      • Nashville, Tennessee, United States, 37203
        • Eye Health Partners & Vision America
    • Texas
      • Austin, Texas, United States, 78705
        • Retina Research Center
      • Denison, Texas, United States, 75020
        • Texoma Retina Center
      • Houston, Texas, United States, 77030
        • Retina Consultants of Houston, PA
      • Mc Allen, Texas, United States, 78504
        • Valley Retina Institute
      • Plano, Texas, United States, 75093
        • Retina Specialists
      • San Antonio, Texas, United States, 78240
        • Retinal Consultants of San Antonio
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthamalogy Associates
      • Tyler, Texas, United States, 75701
        • Eye Care Associates
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah
      • Salt Lake City, Utah, United States, 84107
        • Rocky Mountain Retina Consultants
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • The Retina Group of Washington
      • Virginia Beach, Virginia, United States, 23454
        • Wagner Macula and Retina Center
    • Washington
      • Seattle, Washington, United States, 98133
        • Northwest Eye Surgeons
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

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

Sampling Method

Probability Sample

Study Population

This study will assess clinical outcomes and safety in patients treated with JETREA® administered in a real-world setting for the treatment of symptomatic VMA

Description

Inclusion Criteria:

  • Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label.
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Patients who are treated with JETREA® for medical conditions outside of the US product label.
  • Concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions

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

Cohorts and Interventions

Group / Cohort
ocriplasmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.
Time Frame: 12 Months
12 Months
Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician
Time Frame: 12 months
12 months
Mean change in visual acuity (VA) from baseline across time
Time Frame: 12 months
12 months
Occurrence and time to vitrectomy
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Monitoring of adverse drug reactions (ADRs)
Time Frame: 12 months
12 months
Change from baseline in ocular signs and symptoms across time.
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

ThromboGenics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2014

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-MV-018

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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