Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Status:	Recruiting
Conditions:	Peripheral Vascular Disease, Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	50 - 80
Updated:	3/3/2019
Start Date:	October 2015
End Date:	October 2020
Contact:	Robert Shopbell
Email:	rshopbell@quarkpharma.com
Phone:	510.402.4005

A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

This study will determine the effect of QPI-1007 on visual function in subjects with
recent-onset NAION and assess the safety and tolerability of intravitreal injections of
QPI-1007 in this population. This study will also evaluate the structural changes in the
retina following administration of QPI-1007.

This is a double masked, randomized, sham-controlled efficacy and safety study that will
enroll approximately 800 subjects with recent-onset NAION. Subjects will be randomized into
one of 3 groups in a 1:1:1 ratio, and assigned to receive QPI-1007 and/or a sham procedure.
Subjects will have a two in three (66%) chance of receiving active treatment (no sham
procedure) and a one in three (33%) chance of receiving sham procedure (no active treatment).
Total study time involvement is approximately 12 months.

Key Inclusion Criteria:

- Positive diagnosis of first episode of NAION in the study eye with symptom onset
within 14 days prior to planned study drug administration/sham procedure

- Best corrected visual acuity score in the study eye is better than or equal to 15
letter score, measured using the ETDRS visual acuity protocol at Day 1 prior to study
drug administration/sham procedure.

- Clear ocular media and able to undergo adequate pupil dilation to allow a good fundus
examination

Key Exclusion Criteria:

- Present use or history of any treatment for the current episode of NAION, including
systemic steroids, brimonidine, or traditional Chinese herbal medicine

- Prior episode of NAION in the study eye only

- Present use of drugs known to cause optic nerve or retinal toxicity at Day
1/Randomization, such as: chloroquine or hydroxychloroquine, ethambutol, Vigabatrin.
Subjects who need to be prescribed any of these drugs during the course of the study
will be discontinued from the trial.

- Any medical condition, concomitant therapy, or previous incisional or laser surgery
that, in the opinion of the Investigator, would preclude IVT injection in the study
eye only

- Clinical evidence of temporal arteritis

We found this trial at

sites

Loma Linda University Eye Institute

Loma Linda, California 92354

Principal Investigator: Michael E Rauser, MD

Phone: 909-558-2230

from

Loma Linda, CA

University of Southern California

Los Angeles, California 90033

213) 740-2311

Principal Investigator: Vivek Patel, MD

Phone: 323-865-6935

University of Southern California The University of Southern California is one of the world’s leading...

from

Los Angeles, CA

Univ of Minnesota

Minneapolis, Minnesota 55455

(612) 625-5000

Principal Investigator: Michael Lee, MD

Phone: 612-626-3056

Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...

from

Minneapolis, MN

University of Michigan

500 S State St
Ann Arbor, Michigan 48109

(734) 764-1817

Principal Investigator: Lindsey De Lott, MD

Phone: 734-936-0138

University of Michigan The University of Michigan was founded in 1817 as one of the...

from

Ann Arbor, MI

University of Colorado Denver, Department of Neurology

Aurora, Colorado 80045

Principal Investigator: Jeffery Bennett, MD

Phone: 303-724-7885

from

Aurora, CO

Greater Baltimore Medical Center

6701 N Charles St
Baltimore, Maryland 21204

(443) 849-2000

Principal Investigator: Vivian Rismondo, MD

Phone: 443-849-8067

Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...

from

Baltimore, MD

Bethesda Neurology, LLC

Bethesda, Maryland 20814

Principal Investigator: David Katz, MD

Phone: 301-540-2700

from

Bethesda, MD

Massachusetts Eye & Ear Infirmary

243 Charles St
Boston, Massachusetts 02114

(617) 523-7900

Principal Investigator: Dean Cestari, MD

Phone: 617-838-4768

Massachusetts Eye & Ear Infirmary Whether you see our physicians at Mass. Eye and Ear's...

from

Boston, MA

Boston Med Ctr

Boston, Massachusetts 02118

Principal Investigator: Crandall Peeler, MD

Phone: 617-414-8848

from

Boston, MA

Cape Coral Eye Center

Cape Coral, Florida 33904

Principal Investigator: Michael Tibbetts, MD

Phone: 239-542-2020

from

Cape Coral, FL

Retina Consultants of Charleston

Charleston, South Carolina 29414

Principal Investigator: Virgil Alfaro, MD

Phone: 843-763-4466

from

Charleston, SC

University of Virginia Health Sciences Center

Charlottesville, Virginia 22098

Principal Investigator: Steven Newman, MD

Phone: 434-243-2921

from

Charlottesville, VA

University of Illinois at Chicago, Department of Ophthalmology (MC 648)

Chicago, Illinois 60612

Principal Investigator: Peter W MacIntosh, MD

Phone: 312-355-4866

from

Chicago, IL

Northwestern University

303 East Superior Street
Chicago, Illinois 60611

Principal Investigator: Nicholas Volpe, MD

Phone: 312-472-3568

from

Chicago, IL

Cleveland Clinic - Cole Eye Institute

Cleveland, Ohio 44195

Principal Investigator: Gregory Kosmorsky, DO

Phone: 216-444-1765

from

Cleveland, OH

Retina Consultants of Southern Colorado

Colorado Springs, Colorado

Principal Investigator: James K Luu, MD

Phone: 719-473-9595

from

Colorado Springs, CO

Duke University Eye Center

Durham, North Carolina 27710

Principal Investigator: Gospe Sidney, MD

Phone: 919-681-1569

from

Durham, NC

NorthShore University HealthSystem

Glenview, Illinois 60026

Principal Investigator: John Pula, MD

Phone: 847-657-1750

from

Glenview, IL

University of Houston, Neuro-Ophth of Texas

Houston, Texas 77025

Principal Investigator: Rosa Tang, MD, MPH, MBA

Phone: 713-480-0218

from

Houston, TX

Houston Methodist Hospital, Blanton Eye Institute

Houston, Texas 77030

Principal Investigator: Andrew Lee, MD

Phone: 713-441-3958

from

Houston, TX

University of Kentucky, Department of Neurology

Lexington, Kentucky 40536

Principal Investigator: Padmaja Sudhakar, MD

Phone: 859-323-7452

from

Lexington, KY

University of Arkansas Medical Center, Jones Eye Institute

Little Rock, Arkansas 72205

Principal Investigator: Joseph Chacko, MD

Phone: 501-296-1156

from

Little Rock, AR

NeuroEyeOrbit Institute

8631 West 3rd Street
Los Angeles, California 90048

Principal Investigator: Swaraj Bose, MD

Phone: 310-469-9080

from

Los Angeles, CA

University of Miami Miller School of Medicine/Bascom Palmer Eye Institute

Miami, Florida 33136

Principal Investigator: Byron Lam, MD

Phone: 305-482-4584

from

Miami, FL

New York Eye and Ear Infirmary of Mount Sinai

New York, New York 10003

Principal Investigator: Rudrani Banik, MD

Phone: 212-979-4251

from

New York, NY

Cornell University School of Medicine

New York, New York 10583

Principal Investigator: Marc Dinkin, MD

Phone: 646-962-4118

from

New York, NY

Rutgers New Jersey Medical School

Newark, New Jersey 07103

Principal Investigator: Larry Frohman, MD

Phone: 973-972-3173

from

Newark, NJ

Dean McGee Eye Institute

Oklahoma City, Oklahoma 73104

Principal Investigator: Anil Patel, MD

Phone: 405-271-6307

from

Oklahoma City, OK

University of Nebraska Medical Center, Truhlsen Eye Institute

Omaha, Nebraska 68105

Principal Investigator: Sachin Kedar, MD

Phone: 402-559-1853

from

Omaha, NE

Stanford University

Palo Alto, California 94304

Principal Investigator: Yaping Joyce Liao, MD, PhD

Phone: 650-497-7846

from

Palo Alto, CA

Unversity of California, Los Angeles (UCLA)

Pasadena, California 91105

Principal Investigator: Peter Quiros, MD

Phone: 626-817-4701

from

Pasadena, CA

University of Pennsylvania Scheie Eye Institute

Philadelphia, Pennsylvania 19104

Principal Investigator: Madhura Tamhankar, MD

Phone: 215-662-8038

from

Philadelphia, PA

Raleigh Neurology Associates

Raleigh, North Carolina 27607

Principal Investigator: Syndee Givre, MD, PhD

Phone: 919-782-3456

from

Raleigh, NC

The Mayo Clinic

Rochester, Minnesota 55905

Principal Investigator: John Chen, MD, PhD

Phone: 507-538-8119

from

Rochester, MN

University of Rochester - Flaum Eye Institute

Rochester, New York 14642

Principal Investigator: Zoe Williams, MD

Phone: 585-273-1545

from

Rochester, NY

Washington University in St. Louis

Saint Louis, Missouri 63110

Principal Investigator: Gregory Van Stavern, MD

Phone: 314-286-2946

from

Saint Louis, MO

University of Utah, John A. Moran Eye Center

Salt Lake City, Utah 84132

Principal Investigator: Bradley Katz, MD

Phone: 801-581-5142

from

Salt Lake City, UT

Foresight Studies, LLC

San Antonio, Texas

Principal Investigator: David K Scales, MD

Phone: 210-326-8057

from

San Antonio, TX

Sarasota Retina Institute

Sarasota, Florida 34239

Principal Investigator: Marc H Levy, MD

Phone: 941-921-5335

from

Sarasota, FL

Swedish Medical Center, CO/NOCNW

Seattle, Washington 98104

Principal Investigator: Steven Hamilton, MD

Phone: 206-320-7121

from

Seattle, WA

University of Washington Department of Ophthalmology

Seattle, Washington 98104

Principal Investigator: Courtney Francis, MD

Phone: 206-221-3121

from

Seattle, WA

State Univ of New York at Stony Brook

Stony Brook, New York 11794

Principal Investigator: Patrick Sibony, MD

Phone: 631-444-4511

from

Stony Brook, NY

Sydney Eye Hospital/Save Sight Institute

8 Macquarie Street
Sydney, New South Wales 2000

Principal Investigator: Clare Fraser, MD

Phone: +61 2 9382 7386

from

Sydney,

SUNY Upstate Medical University

750 East Adams Street
Syracuse, New York 13210

Principal Investigator: Louis Mejico, MD

Phone: 315-464-5013

from

Syracuse, NY

The Eye Care Group, PC

Waterbury, Connecticut 06708

Principal Investigator: Robert L Lesser, MD

Phone: 203-573-4897

from

Waterbury, CT

Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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A Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 Delivered By Single or Multi-Dose Intravitreal Injection(s) to Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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