Ocriplasmin Research to Better Inform Treatment (ORBIT)

Status:	Completed
Healthy:	No
Age Range:	18 - Any
Updated:	6/22/2016
Start Date:	May 2014
End Date:	May 2016

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.

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

We found this trial at

110

sites

West Virginia University

Morgantown, West Virginia 26506

(304) 293-0111

Principal Investigator: Ghassan Ghorayeb, MD

West Virginia University West Virginia University, founded in 1867, has a long and rich history...

from

Morgantown, WV

Tufts Medical Center

800 Washington St
Boston, Massachusetts 02111

(617) 636-5000

Principal Investigator: Adam Rogers, MD

Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...

from

Boston, MA

Jules Stein Eye Institute

100 Stein Plaza
Los Angeles, California 90095

Principal Investigator: Jean Pierre Hubschman, MD

from

Los Angeles, CA

Retina Consultants of Hawaii

Aiea, Hawaii 96701

Principal Investigator: Raymond Wee, MD

from

Aiea, HI

Kwiat Eye & Laser Surgery

Amsterdam, New York 12010

Principal Investigator: David Kwiat, MD

from

Amsterdam, NY

Southeast Retina Center, P.C.

Augusta, Georgia 30909

Principal Investigator: Dennis Marcus, MD

from

Augusta, GA

Retina Research Center

Austin, Texas 78705

Principal Investigator: Chirag Jhaveri, MD

from

Austin, TX

Elman Retina Group, PA

Baltimore, Maryland 21237

Principal Investigator: Michael Elman, MD

from

Baltimore, MD

Retina & Vitreous of Louisiana

Baton Rouge, Louisiana 70809

Principal Investigator: John Couvillion, MD

from

Baton Rouge, LA

Retina Vitreous Assciates Medical Group

Beverly Hills, California

Principal Investigator: David Boyer, MD

from

Beverly Hills, CA

Retina Center of New Jersey, LLP

Bloomfield, New Jersey 07003

Principal Investigator: Patrick Higgins, MD

from

Bloomfield, NJ

Ophthalmic Consultants of Boston

Boston, Massachusetts 02114

Principal Investigator: Jeffrey Heier, MD

from

Boston, MA

Harvard Vanguard Medical Associates

Boston, Massachusetts

Principal Investigator: Christopher Andreoli, MD

from

Boston, MA

Pennsylvania Retina Specialists, P.C.

Camp Hill, Pennsylvania 17011

Principal Investigator: Jay Prensky, MD

from

Camp Hill, PA

Carolina Eyecare

Charlestown, South Carolina 29414

Principal Investigator: Robert Brame, MD

from

Charlestown, SC

The Retina Group of Washintong

Chevy Chase, Maryland

Principal Investigator: Mark Johnson, MD

from

Chevy Chase, MD

Chicagoland Retinal Consultants

Chicago, Illinois 60601

Principal Investigator: Ahmed Abdelsalam, MD

from

Chicago, IL

Lions of Illinois Research Institute-Eye and Ear Infirmary

Chicago, Illinois 60612

Principal Investigator: Jennifer Lim, MD

from

Chicago, IL

Rush University Medical Center

1653 W. Congress Parkway
Chicago, Illinois 60612

(312) 942-5000

Principal Investigator: Mathew McCumber, MD

Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...

from

Chicago, IL

Tri-State Centers for Sight

Cincinnati, Ohio 45202

Principal Investigator: Faizuddin Khaja, MD

from

Cincinnati, OH

Eye Care Associates of Greater Cincinnati, Inc.

Cincinnati, Ohio

Principal Investigator: Haroon Chaudhry, MD

from

Cincinnati, OH

Cleveland Clinic Foundation

2049 E 100th St
Cleveland, Ohio 44106

(216) 444-2200

Principal Investigator: Rishi Singh, MD

Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...

from

Cleveland, OH

Georgia Retina, P.C.

Decatur, Georgia 30030

Principal Investigator: Michael Jacobson, MD

from

Decatur, GA

Texoma Retina Center

Denison, Texas 75020

Principal Investigator: Vijay Khetpal, MD

from

Denison, TX

Kresge Eye Institute

Detroit, Michigan 48201

Principal Investigator: Asheesh Tewari, MD

from

Detroit, MI

Duke University Eye Center

Durham, North Carolina 27710

Principal Investigator: Paul Hahn, MD

from

Durham, NC

Retina Vitreous Center in Edmond Oklahoma

Edmond, Oklahoma

Principal Investigator: Sandeep Shah, MD

from

Edmond, OK

Valley Retina Institute, PA

Encino, California

Principal Investigator: Robert Engstrom, MD

from

Encino, CA

Retina Group of Washington

Fairfax, Virginia 22031

Principal Investigator: Alexander Melamud, MD

from

Fairfax, VA

California Eye Institute

Fresno, California 93720

Principal Investigator: George Bertolucci, MD

from

Fresno, CA

Colorado Retina Associates

Golden, Colorado 80401

Principal Investigator: Brian Joondeph, MD

from

Golden, CO

East Carolina Retina Consultants

Greenville, North Carolina 27834

Principal Investigator: Peter Van Houten, MD

from

Greenville, NC

Retina Consultants of Houston

Houston, Texas 77030

Principal Investigator: David Brown, MD

from

Houston, TX

Dr. Thomas Ciulla

Indianapolis, Indiana

Principal Investigator: Thomas Ciulla, MD

from

Indianapolis, IN

Southeastern Retina Associates, PC

Kingsport, Tennessee 37660

Principal Investigator: Joseph Gunn, MD

from

Kingsport, TN

Scripps Clinic at Torrey Pines

La Jolla, California 92037

Principal Investigator: Ray Gariano, MD

from

La Jolla, CA

Acadiana Retina Consultants

Lafayette, Louisiana 70503

Principal Investigator: Jay Culotta, MD

from

Lafayette, LA

Retina Associates of Orange County

Laguna Hills, California 92653

Principal Investigator: Charles Eifrig, MD

from

Laguna Hills, CA

Retina Consultants of Nevada

Las Vegas, Nevada

Principal Investigator: Allen Thach, MD

from

Las Vegas, NV

Capital Retina Associates

Latham, New York 12110

Principal Investigator: Charles Mayron, MD

from

Latham, NY

Delaware Valley Retina Associates

Lawrenceville, New Jersey 08648

Principal Investigator: Jeffrey Lipkowitz, MD

from

Lawrenceville, NJ

Sabates Eye Centers

Leawood, Kansas

Principal Investigator: Michael Casell, MD

from

Leawood, KS

Retina Associates of Kentucky

Lexington, Kentucky 40509

Principal Investigator: Andrew Moshfeghi, MD

from

Lexington, KY

South Coast Retina Center

Long Beach, California 90807

Principal Investigator: Julie Gasperini, MD

from

Long Beach, CA

University of Southern California Medical Center

Los Angeles, California 90033

Principal Investigator: Lisa Olmos, MD

from

Los Angeles, CA

Eye Specialists of Louisville, PSC

Louisville, Kentucky 40292

Principal Investigator: Charles Barr, MD

from

Louisville, KY

Katzen Eye Group

Lutherville, Maryland 21093

Principal Investigator: Michael Grodin, MD

from

Lutherville, MD

Ophthalmic Consultants of Long Island

Lynbrook, New York 11563

Principal Investigator: Daniel Kiernan, MD

from

Lynbrook, NY

Marietta Eye

Marietta, Georgia

Principal Investigator: Lakshmana Kooragayala, MD

from

Marietta, GA

Valley Retina Institute

Mc Allen, Texas 78520

Principal Investigator: Victor Gonzalez, MD

from

Mc Allen, TX

Retina Macula Specialists of Miami

Miami, Florida

Principal Investigator: Gary Shienbaum, MD

from

Miami, FL

MedEye Associates

Miami, Florida 33143

Principal Investigator: Zach Segal, MD

from

Miami, FL

Retina Associates of Cleveland, Inc.

Middleburg Heights, Ohio 44130

Principal Investigator: Joseph Coney, MD

from

Middleburg Heights, OH

Vitreo Retinal Surgery

Minneapolis, Minnesota 55435

Principal Investigator: Polly Quiram, MD

from

Minneapolis, MN

Eye Health Partners & Vision America

Nashville, Tennessee

Principal Investigator: Eric Kostamaa, MD

from

Nashville, TN

NJ Retina

New Brunswick, New Jersey 08901

Principal Investigator: Daniel Roth, MD

from

New Brunswick, NJ

MaculaCare

New York, New York 10021

Principal Investigator: Daniel Rosberger, MD

from

New York, NY

Vitreous-Retina-Macula Consultants of NY,PC

New York, New York

Principal Investigator: James Klancnik, MD

from

New York, NY

Retinal and Ophthalmic Consultants

Northfield, New Jersey

Principal Investigator: Thomas Margolis, MD

from

Northfield, NJ

University Retina and Macula Associates, P.C.

Oak Forest, Illinois 60452

Principal Investigator: Veeral Sheth, MD

from

Oak Forest, IL

niversity of Nebraska Medical Center

OMaha, Nebraska 68198

Principal Investigator: Diana Do, MD

from

OMaha, NE

University of California, Irvine Medical Center

101 The City Drive South
Orange, California 92868

714-456-7890

Principal Investigator: Baruch Kuppermann, MD

University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...

from

Orange, CA

Carl W. Baker

Paducah, Kentucky 42001

Principal Investigator: Carl W Baker, MD

from

Paducah, KY

Bascom-Palmer

Palm Beach Gardens, Florida 33418

Principal Investigator: Jorge Fortun, MD

from

Palm Beach Gardens, FL

Southern California Desert Retina Specialists

Palm Springs, California

Principal Investigator: Clement Chan, MD

from

Palm Springs, CA

Retina Specialty Institute

Pensacola, Florida 32503

Principal Investigator: Sunil Gupta, MD

from

Pensacola, FL

Mid-Atlantic Retina

Philadelphia, Pennsylvania 19107

Principal Investigator: Mitchell Fineman, MD

from

Philadelphia, PA

Retinal Consultants of Arizona

Phoenix, Arizona 85014

Principal Investigator: Karim Jamal, MD

from

Phoenix, AZ

Associated Retina Consultants

Phoenix, Arizona 85020

Principal Investigator: Benjamin Bakall, MD

from

Phoenix, AZ

Associates Ophthalmology and Associates Surgery Centers, LLC

Pittsburgh, Pennsylvania

Principal Investigator: Miguel Busquets, MD

from

Pittsburgh, PA

Allegheny Ophthalmology and Orbital Associates

Pittsburgh, Pennsylvania 15212

Principal Investigator: Thierry Verstraeten, MD

from

Pittsburgh, PA

Retina Specialists

Plano, Texas 75093

Principal Investigator: Robert Torti, MD

from

Plano, TX

Eyesight Ophthalmic Services, PA

Portsmouth, New Hampshire 03801

Principal Investigator: Richard Chace, MD

from

Portsmouth, NH

North Carolina Retina Assoc

Raleigh, North Carolina

Principal Investigator: Sachin Mudvari, MD

from

Raleigh, NC

Black Hills Regional Eye Institute

Rapid City, South Dakota 57701

Principal Investigator: Prema Abraham, MD

from

Rapid City, SD

Sierra Eye Associates

Reno, Nevada 89502

Principal Investigator: Arshad Khanani, MD

from

Reno, NV

William Beaumont Hospital

Royal Oak, Michigan 48073

Principal Investigator: Kimberly Drenser, MD

from

Royal Oak, MI

Lawrence J. Ellison Ambulatory Care Center - UC Health

Sacramento, California 95817

Principal Investigator: Ala Moshiri, MD

from

Sacramento, CA

Retina Associates of Utah

Salt Lake City, Utah

Principal Investigator: Robert Kwun, MD

from

Salt Lake City, UT

Rocky Mountain Retina Consultants

Salt Lake City, Utah 84107

Principal Investigator: Peter Hurlbut-Miller, MD

from

Salt Lake City, UT

Medical Center Ophthamalogy Associates

San Antonio, Texas 78240

Principal Investigator: Michael Singer, MD

from

San Antonio, TX

Retinal Consultants of San Antonio

San Antonio, Texas 78240

Principal Investigator: Calvin Mein, MD

from

San Antonio, TX

Retinal Diagnostic Center

San Jose, California 95116

Principal Investigator: Arm Dessouki, MD

from

San Jose, CA

Orange County Retina Medical

Santa Ana, California 92705

Principal Investigator: Sanford Chen, MD

from

Santa Ana, CA

California Retina Consultants

Santa Barbara, California 93103

Principal Investigator: Dante Pieramici, MD

from

Santa Barbara, CA

Retina Associates of Sarasota

Sarasota, Florida 34233

Principal Investigator: Keye Wong, MD

from

Sarasota, FL

Center for Sight

Sarasota, Florida 34239

Principal Investigator: Michael Parrot, MD

from

Sarasota, FL

Sarasota Retina Institute

Sarasota, Florida 34239

Principal Investigator: Marc H Levy, MD

from

Sarasota, FL

Northwest Eye Surgeons

Seattle, Washington

Principal Investigator: Paul Griggs, MD

from

Seattle, WA

Island Retina

Shirley, New York 11967

Principal Investigator: Pamela Weber, MD

from

Shirley, NY

Illinois Retina Center

Springfield, Illinois

Principal Investigator: David Dodwell, MD

from

Springfield, IL

Barnes Retina Institute

St. Louis, Missouri 63110

Principal Investigator: Gaurav Shah, MD

from

St. Louis, MO

Retina Vitreous Associates of FL

St. Petersburg, Florida 33711

Principal Investigator: David Eichenbaum, MD

from

St. Petersburg, FL

Retina Vitreous Surgeons of Central NY

Syracuse, New York

Principal Investigator: George Hampton, MD

from

Syracuse, NY

Retina Associates of Florida, P.A.

Tampa, Florida 33609

Principal Investigator: Marc Peden, MD

from

Tampa, FL

Retina Associates of New Jersey

Teaneck, New Jersey

Principal Investigator: Leonard Feiner, MD

from

Teaneck, NJ

Eye Care Associates

Tyler, Texas 75701

Principal Investigator: Thomas Bochow, MD

from

Tyler, TX

Carle Research Institute

Urbana, Illinois 61801

Principal Investigator: Michael Tsipursky, MD

from

Urbana, IL

Wagner Macula and Retina Center

Virginia Beach, Virginia

Principal Investigator: Alan Wagner, MD

from

Virginia Beach, VA

The GW Medical Faculty Associates

Washington, District of Columbia 20037

Principal Investigator: Lindsay Smithen, MD

from

Washington,

Wolfe Eye Clinic

West Des Moines, Iowa 50266

Principal Investigator: Jared Nielsen, MD

from

West Des Moines, IA

Ocriplasmin Research to Better Inform Treatment (ORBIT)

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