Clinical trial NCT02079883: Ocriplasmin Research to Better Inform Treatment (ORBIT)
Official title: Ocriplasmin Research to Better Inform Treatment (ORBIT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Symptomatic Vitreomacular Adhesion
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.
timeFrame: 12 Months
measure: Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician
timeFrame: 12 months
measure: Mean change in visual acuity (VA) from baseline across time
timeFrame: 12 months
measure: Occurrence and time to vitrectomy
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: Monitoring of adverse drug reactions (ADRs)
timeFrame: 12 months
measure: Change from baseline in ocular signs and symptoms across time.
timeFrame: 12 months
Locations:
city: Phoenix
country: United States
facility: Retinal COnsultants of Arizona
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd
state: Arizona
city: Beverly Hills
country: United States
facility: Retina Vitreous Assciates Medical Group
state: California
city: Encino
country: United States
facility: Valley Retina Institute, PA
state: California
city: Fresno
country: United States
facility: California Eye Institute
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Torrey Pines
state: California
city: Laguna Hills
country: United States
facility: Retina Associates of Orange County
state: California
city: Long Beach
country: United States
facility: South Coast Retina Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California Medical Center
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: Palm Springs
country: United States
facility: Southern California Desert Retina Specialists
state: California
city: Sacramento
country: United States
facility: Lawrence J. Ellison Ambulatory Care Center - UC Health
state: California
city: San Jose
country: United States
facility: Retinal Diagnostic Center
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
city: Miami
country: United States
facility: Retina Macula Specialists of Miami
state: Florida
city: Miami
country: United States
facility: MedEye Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom-Palmer
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Sarasota
country: United States
facility: Retina Associates of Sarasota
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Sarasota
country: United States
facility: Sarasota Retina Institute
state: Florida
city: St. Petersburg
country: United States
facility: Retina Vitreous Associates of FL
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Decatur
country: United States
facility: Georgia Retina
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye
state: Georgia
city: Aiea
country: United States
facility: Retina Consultants of Hawaii, Inc
state: Hawaii
city: Chicago
country: United States
facility: Chicagoland Retinal Consultants
state: Illinois
city: Chicago
country: United States
facility: Lions of Illinois Research Institute-Eye and Ear Infirmary
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, P.C.
state: Illinois
city: Springfield
country: United States
facility: Illinois Retina Center
state: Illinois
city: Urbana
country: United States
facility: Carle Research Institute
state: Illinois
city: Indianapolis
country: United States
facility: Dr. Thomas Ciulla
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Leawood
country: United States
facility: Sabates Eye Centers
state: Kansas
city: Wichita
country: United States
facility: Vitreo-Retinal Consultants & Surgeons
state: Kansas
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Eye Specialists of Louisville, PSC
state: Kentucky
city: Paducah
country: United States
facility: Carl W Baker
state: Kentucky
city: Baton Rouge
country: United States
facility: Retina & Vitreous of Louisiana
state: Louisiana
city: Lafayette
country: United States
facility: Acadiana Retina Consultants
state: Louisiana
city: West Monroe
country: United States
facility: Haik Humble Eye Center
state: Louisiana
city: Baltimore
country: United States
facility: Elman Retina Group, PA
state: Maryland
city: Chevy Chase
country: United States
facility: The Retina Group of Washintong
state: Maryland
city: Lutherville
country: United States
facility: Katzen Eye Group
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Worcerster
country: United States
facility: Vitroretinal Assciates
state: Massachusetts
city: Worcester
country: United States
facility: Central Mass Retina & Uveitis Center
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Vitreo Retinal Surgery
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Retina Institute
state: Missouri
city: OMaha
country: United States
facility: niversity of Nebraska Medical Center
state: Nebraska
city: Las Vegas
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services
state: New Hampshire
city: Bloomfield
country: United States
facility: Retina Center of New Jersey, LLP
state: New Jersey
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates
state: New Jersey
city: New Brunswick
country: United States
facility: NJ Retina
state: New Jersey
city: Northfield
country: United States
facility: Retinal and Ophthalmic Consultants
state: New Jersey
city: Teaneck
country: United States
facility: Retina Associates Of New Jersey, Pa
state: New Jersey
city: Amsterdam
country: United States
facility: Kwiat Eye & Laser Surgery
state: New York
city: Latham
country: United States
facility: Capital Retina Associates
state: New York
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: New York
country: United States
facility: MaculaCare
state: New York
city: New York
country: United States
facility: Vitreous-Retina-Macula Consultants of NY,PC
state: New York
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of Central NY
state: New York
city: Wilton
country: United States
facility: Capital Region Retina
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina Retina Consultants
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Retina Assoc
state: North Carolina
city: Wilmington
country: United States
facility: Cape Fear Retina
state: North Carolina
city: Winston Salem
country: United States
facility: Dr Mark Nelson
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Centers for Sight
state: Ohio
city: Cincinnati
country: United States
facility: Eye Care Associates of Greater Cincinnati, Inc.
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Middleburg Heights
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center in Edmond Oklahoma
state: Oklahoma
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Associates Ophthalmology and Associates Surgery Centers, LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Ophthalmology and Orbital Associates
state: Pennsylvania
city: Charlestown
country: United States
facility: Carolina Eyecare
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Kingsport
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Nashville
country: United States
facility: Eye Health Partners & Vision America
state: Tennessee
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Denison
country: United States
facility: Texoma Retina Center
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston, PA
state: Texas
city: Mc Allen
country: United States
facility: Valley Retina Institute
state: Texas
city: Plano
country: United States
facility: Retina Specialists
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthamalogy Associates
state: Texas
city: San Antonio
country: United States
facility: Retinal Consultants of San Antonio
state: Texas
city: Tyler
country: United States
facility: Eye Care Associates
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Fairfax
country: United States
facility: The Retina Group of Washington
state: Virginia
city: Virginia Beach
country: United States
facility: Wagner Macula and Retina Center
state: Virginia
city: Seattle
country: United States
facility: Northwest Eye Surgeons
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
citation: 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.