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

Use our guide to learn which trials are right for you!

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
45
sites
Philadelphia, Pennsylvania 19104
Principal Investigator: Madhura Tamhankar, MD
Phone: 215-662-8038
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Aurora, Colorado 80045
Principal Investigator: Jeffery Bennett, MD
Phone: 303-724-7885
?
mi
from
Aurora, CO
Click here to add this to my saved trials
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...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethesda, Maryland 20814
Principal Investigator: David Katz, MD
Phone: 301-540-2700
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
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...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02118
Principal Investigator: Crandall Peeler, MD
Phone: 617-414-8848
?
mi
from
Boston, MA
Click here to add this to my saved trials
Cape Coral, Florida 33904
Principal Investigator: Michael Tibbetts, MD
Phone: 239-542-2020
?
mi
from
Cape Coral, FL
Click here to add this to my saved trials
Charleston, South Carolina 29414
Principal Investigator: Virgil Alfaro, MD
Phone: 843-763-4466
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlottesville, Virginia 22098
Principal Investigator: Steven Newman, MD
Phone: 434-243-2921
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chicago, Illinois 60612
Principal Investigator: Peter W MacIntosh, MD
Phone: 312-355-4866
?
mi
from
Chicago, IL
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Nicholas Volpe, MD
Phone: 312-472-3568
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cleveland, Ohio 44195
Principal Investigator: Gregory Kosmorsky, DO
Phone: 216-444-1765
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado
Principal Investigator: James K Luu, MD
Phone: 719-473-9595
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Durham, North Carolina 27710
Principal Investigator: Gospe Sidney, MD
Phone: 919-681-1569
?
mi
from
Durham, NC
Click here to add this to my saved trials
Glenview, Illinois 60026
Principal Investigator: John Pula, MD
Phone: 847-657-1750
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Houston, Texas 77025
Principal Investigator: Rosa Tang, MD, MPH, MBA
Phone: 713-480-0218
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Andrew Lee, MD
Phone: 713-441-3958
?
mi
from
Houston, TX
Click here to add this to my saved trials
Lexington, Kentucky 40536
Principal Investigator: Padmaja Sudhakar, MD
Phone: 859-323-7452
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Principal Investigator: Joseph Chacko, MD
Phone: 501-296-1156
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Loma Linda, California 92354
Principal Investigator: Michael E Rauser, MD
Phone: 909-558-2230
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
8631 West 3rd Street
Los Angeles, California 90048
Principal Investigator: Swaraj Bose, MD
Phone: 310-469-9080
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33136
Principal Investigator: Byron Lam, MD
Phone: 305-482-4584
?
mi
from
Miami, FL
Click here to add this to my saved trials
New York, New York 10003
Principal Investigator: Rudrani Banik, MD
Phone: 212-979-4251
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10583
Principal Investigator: Marc Dinkin, MD
Phone: 646-962-4118
?
mi
from
New York, NY
Click here to add this to my saved trials
Newark, New Jersey 07103
Principal Investigator: Larry Frohman, MD
Phone: 973-972-3173
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73104
Principal Investigator: Anil Patel, MD
Phone: 405-271-6307
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Omaha, Nebraska 68105
Principal Investigator: Sachin Kedar, MD
Phone: 402-559-1853
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Palo Alto, California 94304
Principal Investigator: Yaping Joyce Liao, MD, PhD
Phone: 650-497-7846
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Pasadena, California 91105
Principal Investigator: Peter Quiros, MD
Phone: 626-817-4701
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Raleigh, North Carolina 27607
Principal Investigator: Syndee Givre, MD, PhD
Phone: 919-782-3456
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, Minnesota 55905
Principal Investigator: John Chen, MD, PhD
Phone: 507-538-8119
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Rochester, New York 14642
Principal Investigator: Zoe Williams, MD
Phone: 585-273-1545
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Principal Investigator: Gregory Van Stavern, MD
Phone: 314-286-2946
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salt Lake City, Utah 84132
Principal Investigator: Bradley Katz, MD
Phone: 801-581-5142
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Antonio, Texas
Principal Investigator: David K Scales, MD
Phone: 210-326-8057
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sarasota, Florida 34239
Principal Investigator: Marc H Levy, MD
Phone: 941-921-5335
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Steven Hamilton, MD
Phone: 206-320-7121
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Courtney Francis, MD
Phone: 206-221-3121
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Stony Brook, New York 11794
Principal Investigator: Patrick Sibony, MD
Phone: 631-444-4511
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
8 Macquarie Street
Sydney, New South Wales 2000
Principal Investigator: Clare Fraser, MD
Phone: +61 2 9382 7386
?
mi
from
Sydney,
Click here to add this to my saved trials
750 East Adams Street
Syracuse, New York 13210
Principal Investigator: Louis Mejico, MD
Phone: 315-464-5013
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Waterbury, Connecticut 06708
Principal Investigator: Robert L Lesser, MD
Phone: 203-573-4897
?
mi
from
Waterbury, CT
Click here to add this to my saved trials