Ocriplasmin Research to Better Inform Treatment (ORBIT)
- Conditions
- Symptomatic Vitreomacular Adhesion
- Registration Number
- NCT02079883
- Lead Sponsor
- ThromboGenics
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 540
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Occurrence and time to vitrectomy 12 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (110)
Retina Vitreous Associates of FL
🇺🇸St. Petersburg, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Georgia Retina
🇺🇸Decatur, Georgia, United States
Marietta Eye
🇺🇸Marietta, Georgia, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Chicagoland Retinal Consultants
🇺🇸Chicago, Illinois, United States
Lions of Illinois Research Institute-Eye and Ear Infirmary
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Allegheny Ophthalmology and Orbital Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Dr. Thomas Ciulla
🇺🇸Indianapolis, Indiana, United States
Associated Retina Consultants, Ltd
🇺🇸Phoenix, Arizona, United States
Retinal COnsultants of Arizona
🇺🇸Phoenix, Arizona, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
Vitreo Retinal Surgery
🇺🇸Minneapolis, Minnesota, United States
Retina Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
Medical Center Ophthamalogy Associates
🇺🇸San Antonio, Texas, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina Associates of Utah
🇺🇸Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
niversity of Nebraska Medical Center
🇺🇸OMaha, Nebraska, United States
Retina Associates of Florida
🇺🇸Tampa, Florida, United States
Harvard Vanguard Medical Associates
🇺🇸Boston, Massachusetts, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Eye Specialists of Louisville, PSC
🇺🇸Louisville, Kentucky, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
South Coast Retina Center
🇺🇸Long Beach, California, United States
California Eye Institute
🇺🇸Fresno, California, United States
Scripps Clinic Torrey Pines
🇺🇸La Jolla, California, United States
Retina Associates of Orange County
🇺🇸Laguna Hills, California, United States
Retina Vitreous Assciates Medical Group
🇺🇸Beverly Hills, California, United States
Valley Retina Institute, PA
🇺🇸Encino, California, United States
Illinois Retina Center
🇺🇸Springfield, Illinois, United States
Orange County Retina Medical
🇺🇸Santa Ana, California, United States
Center for Sight
🇺🇸Sarasota, Florida, United States
University of Southern California Medical Center
🇺🇸Los Angeles, California, United States
Retina Macula Specialists of Miami
🇺🇸Miami, Florida, United States
MedEye Associates
🇺🇸Miami, Florida, United States
Southern California Desert Retina Specialists
🇺🇸Palm Springs, California, United States
Bascom-Palmer
🇺🇸Palm Beach Gardens, Florida, United States
The GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Jules Stein Eye Institute
🇺🇸Los Angeles, California, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Lawrence J. Ellison Ambulatory Care Center - UC Health
🇺🇸Sacramento, California, United States
University of California at Irvine Medical Center
🇺🇸Orange, California, United States
Retinal Diagnostic Center
🇺🇸San Jose, California, United States
Retina Consultants of Hawaii, Inc
🇺🇸Aiea, Hawaii, United States
Retina Associates of Sarasota
🇺🇸Sarasota, Florida, United States
Vitreo-Retinal Consultants & Surgeons
🇺🇸Wichita, Kansas, United States
Carle Research Institute
🇺🇸Urbana, Illinois, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Colorado Retina Associates
🇺🇸Golden, Colorado, United States
Center for Retina & Macular Disease
🇺🇸Winter Haven, Florida, United States
Sabates Eye Centers
🇺🇸Leawood, Kansas, United States
Carl W Baker
🇺🇸Paducah, Kentucky, United States
University Retina and Macula Associates, P.C.
🇺🇸Oak Forest, Illinois, United States
Retina & Vitreous of Louisiana
🇺🇸Baton Rouge, Louisiana, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
Elman Retina Group, PA
🇺🇸Baltimore, Maryland, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Tufts Medical Center, Inc.
🇺🇸Boston, Massachusetts, United States
Retinal and Ophthalmic Consultants
🇺🇸Northfield, New Jersey, United States
Acadiana Retina Consultants
🇺🇸Lafayette, Louisiana, United States
The Retina Group of Washintong
🇺🇸Chevy Chase, Maryland, United States
Central Mass Retina & Uveitis Center
🇺🇸Worcester, Massachusetts, United States
Barnes Retina Institute
🇺🇸St. Louis, Missouri, United States
NJ Retina
🇺🇸New Brunswick, New Jersey, United States
Katzen Eye Group
🇺🇸Lutherville, Maryland, United States
Eyesight Ophthalmic Services
🇺🇸Portsmouth, New Hampshire, United States
Retina Center of New Jersey, LLP
🇺🇸Bloomfield, New Jersey, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
Retina Associates Of New Jersey, Pa
🇺🇸Teaneck, New Jersey, United States
Kwiat Eye & Laser Surgery
🇺🇸Amsterdam, New York, United States
Vitroretinal Assciates
🇺🇸Worcerster, Massachusetts, United States
MaculaCare
🇺🇸New York, New York, United States
Capital Region Retina
🇺🇸Wilton, New York, United States
Dr Mark Nelson
🇺🇸Winston Salem, North Carolina, United States
North Carolina Retina Assoc
🇺🇸Raleigh, North Carolina, United States
East Carolina Retina Consultants
🇺🇸Greenville, North Carolina, United States
Associates Ophthalmology and Associates Surgery Centers, LLC
🇺🇸Pittsburgh, Pennsylvania, United States
Capital Retina Associates
🇺🇸Latham, New York, United States
Ophthalmic Consultants of Long Island
🇺🇸Lynbrook, New York, United States
Vitreous-Retina-Macula Consultants of NY,PC
🇺🇸New York, New York, United States
Cape Fear Retina
🇺🇸Wilmington, North Carolina, United States
Tri-State Centers for Sight
🇺🇸Cincinnati, Ohio, United States
Eye Care Associates of Greater Cincinnati, Inc.
🇺🇸Cincinnati, Ohio, United States
Retina Associates of Cleveland
🇺🇸Middleburg Heights, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Island Retina
🇺🇸Shirley, New York, United States
Valley Retina Institute
🇺🇸Mc Allen, Texas, United States
Retina Vitreous Surgeons of Central NY
🇺🇸Syracuse, New York, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Southeastern Retina Associates
🇺🇸Kingsport, Tennessee, United States
Texoma Retina Center
🇺🇸Denison, Texas, United States
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Eye Health Partners & Vision America
🇺🇸Nashville, Tennessee, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Pennsylvania Retina Specialists PC
🇺🇸Camp Hill, Pennsylvania, United States
Carolina Eyecare
🇺🇸Charlestown, South Carolina, United States
The Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Wagner Macula and Retina Center
🇺🇸Virginia Beach, Virginia, United States
Retina Specialists
🇺🇸Plano, Texas, United States
Eye Care Associates
🇺🇸Tyler, Texas, United States
Northwest Eye Surgeons
🇺🇸Seattle, Washington, United States
Retina Vitreous Center in Edmond Oklahoma
🇺🇸Edmond, Oklahoma, United States