Ocriplasmin Research to Better Inform Treatment (ORBIT)
ORBIT
1 other identifier
observational
540
1 country
110
Brief 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 120 USA retina sites.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedJune 21, 2016
June 1, 2016
2 years
March 4, 2014
June 20, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.
12 Months
Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician
12 months
Mean change in visual acuity (VA) from baseline across time
12 months
Occurrence and time to vitrectomy
12 months
Other Outcomes (2)
Monitoring of adverse drug reactions (ADRs)
12 months
Change from baseline in ocular signs and symptoms across time.
12 months
Study Arms (1)
ocriplasmin
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (110)
Retinal COnsultants of Arizona
Phoenix, Arizona, 85014, United States
Associated Retina Consultants, Ltd
Phoenix, Arizona, 85020, United States
Retina Vitreous Assciates Medical Group
Beverly Hills, California, 90211, United States
Valley Retina Institute, PA
Encino, California, 91436, United States
California Eye Institute
Fresno, California, 93720, United States
Scripps Clinic Torrey Pines
La Jolla, California, 92037, United States
Retina Associates of Orange County
Laguna Hills, California, 92653, United States
South Coast Retina Center
Long Beach, California, 90807-2008, United States
University of Southern California Medical Center
Los Angeles, California, 90032, United States
Jules Stein Eye Institute
Los Angeles, California, 90095-7004, United States
University of California at Irvine Medical Center
Orange, California, 92868, United States
Southern California Desert Retina Specialists
Palm Springs, California, 92262, United States
Lawrence J. Ellison Ambulatory Care Center - UC Health
Sacramento, California, 95817, United States
Retinal Diagnostic Center
San Jose, California, 95116, United States
Orange County Retina Medical
Santa Ana, California, 92705, United States
California Retina Consultants
Santa Barbara, California, 93103, United States
Colorado Retina Associates
Golden, Colorado, 80401, United States
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037, United States
Retina Macula Specialists of Miami
Miami, Florida, 33126, United States
MedEye Associates
Miami, Florida, 33143, United States
Bascom-Palmer
Palm Beach Gardens, Florida, 33418, United States
Retina Specialty Institute
Pensacola, Florida, 32503-2030, United States
Retina Associates of Sarasota
Sarasota, Florida, 34233, United States
Center for Sight
Sarasota, Florida, 34239, United States
Sarasota Retina Institute
Sarasota, Florida, 34239, United States
Retina Vitreous Associates of FL
St. Petersburg, Florida, 33711, United States
Retina Associates of Florida
Tampa, Florida, 33609, United States
Center for Retina & Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina
Decatur, Georgia, 30030, United States
Marietta Eye
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii, Inc
‘Aiea, Hawaii, 96701, United States
Chicagoland Retinal Consultants
Chicago, Illinois, 60601, United States
Lions of Illinois Research Institute-Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University Retina and Macula Associates, P.C.
Oak Forest, Illinois, 60452, United States
Illinois Retina Center
Springfield, Illinois, 62704, United States
Carle Research Institute
Urbana, Illinois, 61801, United States
Dr. Thomas Ciulla
Indianapolis, Indiana, 46280, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Sabates Eye Centers
Leawood, Kansas, 66211, United States
Vitreo-Retinal Consultants & Surgeons
Wichita, Kansas, 67214, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40503, United States
Eye Specialists of Louisville, PSC
Louisville, Kentucky, 40292, United States
Carl W Baker
Paducah, Kentucky, 42001, United States
Retina & Vitreous of Louisiana
Baton Rouge, Louisiana, 70809, United States
Acadiana Retina Consultants
Lafayette, Louisiana, 70503, United States
Haik Humble Eye Center
West Monroe, Louisiana, 71291, United States
Elman Retina Group, PA
Baltimore, Maryland, 21237, United States
The Retina Group of Washintong
Chevy Chase, Maryland, 20815, United States
Katzen Eye Group
Lutherville, Maryland, 21093, United States
Tufts Medical Center, Inc.
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215, United States
Vitroretinal Assciates
Worcerster, Massachusetts, 01605, United States
Central Mass Retina & Uveitis Center
Worcester, Massachusetts, 01613, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Vitreo Retinal Surgery
Minneapolis, Minnesota, 55435, United States
Barnes Retina Institute
St Louis, Missouri, 63144, United States
niversity of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Retina Consultants of Nevada
Las Vegas, Nevada, 89144, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801, United States
Retina Center of New Jersey, LLP
Bloomfield, New Jersey, 07003, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
NJ Retina
New Brunswick, New Jersey, 08901, United States
Retinal and Ophthalmic Consultants
Northfield, New Jersey, 08225, United States
Retina Associates Of New Jersey, Pa
Teaneck, New Jersey, 07666, United States
Kwiat Eye & Laser Surgery
Amsterdam, New York, 12010, United States
Capital Retina Associates
Latham, New York, 12110, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
MaculaCare
New York, New York, 10021, United States
Vitreous-Retina-Macula Consultants of NY,PC
New York, New York, 10022, United States
Island Retina
Shirley, New York, 11967, United States
Retina Vitreous Surgeons of Central NY
Syracuse, New York, 13224, United States
Capital Region Retina
Wilton, New York, 12831, United States
Duke University Eye Center
Durham, North Carolina, 27705, United States
East Carolina Retina Consultants
Greenville, North Carolina, 27834, United States
North Carolina Retina Assoc
Raleigh, North Carolina, 27607, United States
Cape Fear Retina
Wilmington, North Carolina, 28401, United States
Dr Mark Nelson
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
Tri-State Centers for Sight
Cincinnati, Ohio, 45202, United States
Eye Care Associates of Greater Cincinnati, Inc.
Cincinnati, Ohio, 45227, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130, United States
Retina Vitreous Center in Edmond Oklahoma
Edmond, Oklahoma, 73013, United States
Pennsylvania Retina Specialists PC
Camp Hill, Pennsylvania, 17011-1776, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Associates Ophthalmology and Associates Surgery Centers, LLC
Pittsburgh, Pennsylvania, 15122, United States
Allegheny Ophthalmology and Orbital Associates
Pittsburgh, Pennsylvania, 15212, United States
Carolina Eyecare
Charlestown, South Carolina, 29414, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates
Kingsport, Tennessee, 37660, United States
Eye Health Partners & Vision America
Nashville, Tennessee, 37203, United States
Retina Research Center
Austin, Texas, 78705, United States
Texoma Retina Center
Denison, Texas, 75020, United States
Retina Consultants of Houston, PA
Houston, Texas, 77030, United States
Valley Retina Institute
McAllen, Texas, 78504, United States
Retina Specialists
Plano, Texas, 75093, United States
Medical Center Ophthamalogy Associates
San Antonio, Texas, 78240, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78240, United States
Eye Care Associates
Tyler, Texas, 75701, United States
Retina Associates of Utah
Salt Lake City, Utah, 84107, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
The Retina Group of Washington
Fairfax, Virginia, 22031, United States
Wagner Macula and Retina Center
Virginia Beach, Virginia, 23454, United States
Northwest Eye Surgeons
Seattle, Washington, 98133, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (1)
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.
PMID: 30935657DERIVED
Biospecimen
No biospecimens collected
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 6, 2014
Study Start
May 1, 2014
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
June 21, 2016
Record last verified: 2016-06