Ocriplasmin Research to Better Inform Treatment (ORBIT)

Symptomatic Vitreomacular Adhesion Clinical Trial

— ORBIT  

Official title:

Ocriplasmin Research to Better Inform Treatment (ORBIT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02079883
• Other study ID #: TG-MV-018
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: June 20, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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 120 USA retina sites.

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 information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Symptomatic Vitreomacular Adhesion

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitoring of adverse drug reactions (ADRs)		12 months	Yes
Other	Change from baseline in ocular signs and symptoms across time.		12 months	Yes
Primary	Resolution of VMA by Spectral-domain optical coherence tomography (SD-OCT) as determined by the treating physician.		12 Months	No
Primary	Full thickness macular hole (FTMH) closure by SD-OCT as determined by the treating physician		12 months	No
Primary	Mean change in visual acuity (VA) from baseline across time		12 months	No
Primary	Occurrence and time to vitrectomy		12 months	No