Symptomatic Vitreomacular AdhesionORBITNCT02079883
Ocriplasmin Research to Better Inform Treatment (ORBIT)
An observational study of Symptomatic Vitreomacular Adhesion, run by ThromboGenics at 110 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptomatic Vitreomacular Adhesion
- How many people
- 540 participants
- Where
- 110 sitesUnited States
- Study dates
- May 2014to May 2016
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
110 sites in 1 country.
110 sites in 1 country
United States110 sites
Retina Consultants of Hawaii, Inc
‘Aiea, Hawaii, 96701
Kwiat Eye & Laser Surgery
Amsterdam, New York, 12010
Southeast Retina Center
Augusta, Georgia, 30909
Retina Research Center
Austin, Texas, 78705
Elman Retina Group, PA
Baltimore, Maryland, 21237
Retina & Vitreous of Louisiana
Baton Rouge, Louisiana, 70809
Retina Vitreous Assciates Medical Group
Beverly Hills, California, 90211
Retina Center of New Jersey, LLP
Bloomfield, New Jersey, 07003
Tufts Medical Center, Inc.
Boston, Massachusetts, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215
Pennsylvania Retina Specialists PC
Camp Hill, Pennsylvania, 17011-1776
Carolina Eyecare
Charlestown, South Carolina, 29414
The Retina Group of Washintong
Chevy Chase, Maryland, 20815
Chicagoland Retinal Consultants
Chicago, Illinois, 60601
Lions of Illinois Research Institute-Eye and Ear Infirmary
Chicago, Illinois, 60612
Rush University Medical Center
Chicago, Illinois, 60612
Tri-State Centers for Sight
Cincinnati, Ohio, 45202
Eye Care Associates of Greater Cincinnati, Inc.
Cincinnati, Ohio, 45227
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Georgia Retina
Decatur, Georgia, 30030
Texoma Retina Center
Denison, Texas, 75020
Kresge Eye Institute
Detroit, Michigan, 48201
Duke University Eye Center
Durham, North Carolina, 27705
Retina Vitreous Center in Edmond Oklahoma
Edmond, Oklahoma, 73013
Valley Retina Institute, PA
Encino, California, 91436
The Retina Group of Washington
Fairfax, Virginia, 22031
California Eye Institute
Fresno, California, 93720
Colorado Retina Associates
Golden, Colorado, 80401
East Carolina Retina Consultants
Greenville, North Carolina, 27834
Retina Consultants of Houston, PA
Houston, Texas, 77030
Dr. Thomas Ciulla
Indianapolis, Indiana, 46280
Southeastern Retina Associates
Kingsport, Tennessee, 37660
Scripps Clinic Torrey Pines
La Jolla, California, 92037
Acadiana Retina Consultants
Lafayette, Louisiana, 70503
Retina Associates of Orange County
Laguna Hills, California, 92653
Retina Consultants of Nevada
Las Vegas, Nevada, 89144
Capital Retina Associates
Latham, New York, 12110
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648
Sabates Eye Centers
Leawood, Kansas, 66211
Retina Associates of Kentucky
Lexington, Kentucky, 40503
South Coast Retina Center
Long Beach, California, 90807-2008
University of Southern California Medical Center
Los Angeles, California, 90032
Jules Stein Eye Institute
Los Angeles, California, 90095-7004
Eye Specialists of Louisville, PSC
Louisville, Kentucky, 40292
Katzen Eye Group
Lutherville, Maryland, 21093
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Marietta Eye
Marietta, Georgia, 30060
Valley Retina Institute
McAllen, Texas, 78504
Retina Macula Specialists of Miami
Miami, Florida, 33126
MedEye Associates
Miami, Florida, 33143
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130
Vitreo Retinal Surgery
Minneapolis, Minnesota, 55435
West Virginia University
Morgantown, West Virginia, 26506
Eye Health Partners & Vision America
Nashville, Tennessee, 37203
NJ Retina
New Brunswick, New Jersey, 08901
MaculaCare
New York, New York, 10021
Vitreous-Retina-Macula Consultants of NY,PC
New York, New York, 10022
Retinal and Ophthalmic Consultants
Northfield, New Jersey, 08225
University Retina and Macula Associates, P.C.
Oak Forest, Illinois, 60452
niversity of Nebraska Medical Center
Omaha, Nebraska, 68198
University of California at Irvine Medical Center
Orange, California, 92868
Carl W Baker
Paducah, Kentucky, 42001
Bascom-Palmer
Palm Beach Gardens, Florida, 33418
Southern California Desert Retina Specialists
Palm Springs, California, 92262
Retina Specialty Institute
Pensacola, Florida, 32503-2030
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retinal COnsultants of Arizona
Phoenix, Arizona, 85014
Associated Retina Consultants, Ltd
Phoenix, Arizona, 85020
Associates Ophthalmology and Associates Surgery Centers, LLC
Pittsburgh, Pennsylvania, 15122
Allegheny Ophthalmology and Orbital Associates
Pittsburgh, Pennsylvania, 15212
Retina Specialists
Plano, Texas, 75093
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801
North Carolina Retina Assoc
Raleigh, North Carolina, 27607
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Sierra Eye Associates
Reno, Nevada, 89502
William Beaumont Hospital
Royal Oak, Michigan, 48073
Lawrence J. Ellison Ambulatory Care Center - UC Health
Sacramento, California, 95817
Retina Associates of Utah
Salt Lake City, Utah, 84107
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
Medical Center Ophthamalogy Associates
San Antonio, Texas, 78240
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Retinal Diagnostic Center
San Jose, California, 95116
Orange County Retina Medical
Santa Ana, California, 92705
California Retina Consultants
Santa Barbara, California, 93103
Retina Associates of Sarasota
Sarasota, Florida, 34233
Center for Sight
Sarasota, Florida, 34239
Sarasota Retina Institute
Sarasota, Florida, 34239
Northwest Eye Surgeons
Seattle, Washington, 98133
Island Retina
Shirley, New York, 11967
Illinois Retina Center
Springfield, Illinois, 62704
Barnes Retina Institute
St Louis, Missouri, 63144
Retina Vitreous Associates of FL
St. Petersburg, Florida, 33711
Retina Vitreous Surgeons of Central NY
Syracuse, New York, 13224
Retina Associates of Florida
Tampa, Florida, 33609
Retina Associates Of New Jersey, Pa
Teaneck, New Jersey, 07666
Eye Care Associates
Tyler, Texas, 75701
Carle Research Institute
Urbana, Illinois, 61801
Wagner Macula and Retina Center
Virginia Beach, Virginia, 23454
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Haik Humble Eye Center
West Monroe, Louisiana, 71291
Vitreo-Retinal Consultants & Surgeons
Wichita, Kansas, 67214
Cape Fear Retina
Wilmington, North Carolina, 28401
Capital Region Retina
Wilton, New York, 12831
Dr Mark Nelson
Winston-Salem, North Carolina, 27103
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27103
Center for Retina & Macular Disease
Winter Haven, Florida, 33880
Vitroretinal Assciates
Worcerster, Massachusetts, 01605
Central Mass Retina & Uveitis Center
Worcester, Massachusetts, 01613
About this study
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.
Read the 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.
- Conditions
- Symptomatic Vitreomacular Adhesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ocriplasmin | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.
Measured: 12 Months
Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician
Measured: 12 months
Mean change in visual acuity (VA) from baseline across time
Measured: 12 months
Occurrence and time to vitrectomy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Vitreomacular AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079883
- Sponsor's protocol ID
- TG-MV-018
- Acronym
- ORBIT
- Status last verified
- Jun 2016
- First submitted
- 4 Mar 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Khanani AM, Duker JS, Heier JS, Kaiser PK, Joondeph BC, Kozma P, Rosberger DF, MacCumber M, Boyer DS, Pieramici DJ. Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study. Ophthalmol Retina. 2019 Jan;3(1):32-41. doi: 10.1016/j.oret.2018.07.011. Epub 2018 Jul 25.
PubMed 30935657
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocriplasmin Research to Better Inform Treatment (ORBIT)
- ClinicalTrials.gov ID
- NCT02079883
- Acronym / sponsor ID
- ORBIT / TG-MV-018
- Conditions
- Symptomatic Vitreomacular Adhesion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ocriplasmin | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.
Time frame: 12 Months
Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician
Time frame: 12 months
Mean change in visual acuity (VA) from baseline across time
Time frame: 12 months
Occurrence and time to vitrectomy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- Derived from this study: PubMed 30935657Khanani AM, Duker JS, Heier JS, Kaiser PK, Joondeph BC, Kozma P, Rosberger DF, MacCumber M, Boyer DS, Pieramici DJ. Ocriplasmin Treatment Leads to Symptomatic Vitreomacular Adhesion/Vitreomacular Traction Resolution in the Real-World Setting: The Phase IV ORBIT Study. Ophthalmol Retina. 2019 Jan;3(1):32-41. doi: 10.1016/j.oret.2018.07.011. Epub 2018 Jul 25.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
110 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Vitreomacular Adhesion, run by ThromboGenics at 110 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician. (time frame: 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2016.