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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocriplasmin |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of adverse drug reactions (ADRs) | 12 months | |
| Change from baseline in ocular signs and symptoms across time. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal COnsultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Associated Retina Consultants, Ltd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30935657 | Derived | 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. |
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No biospecimens collected
| 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 |