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

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 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 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

Loma Linda University Eye Institute

Loma Linda, California 92354

Principal Investigator: Michael E Rauser, MD

Phone: 909-558-2230

from

Loma Linda, CA

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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