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.
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.
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
Little Rock, Arkansas 72205
Principal Investigator: Joseph Chacko, MD
Phone: 501-296-1156
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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...
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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...
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500 S State St
Ann Arbor, Michigan 48109
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...
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Aurora, Colorado 80045
Principal Investigator: Jeffery Bennett, MD
Phone: 303-724-7885
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6701 N Charles St
Baltimore, Maryland 21204
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...
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Bethesda, Maryland 20814
Principal Investigator: David Katz, MD
Phone: 301-540-2700
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243 Charles St
Boston, Massachusetts 02114
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...
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Boston, Massachusetts 02118
Principal Investigator: Crandall Peeler, MD
Phone: 617-414-8848
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Cape Coral, Florida 33904
Principal Investigator: Michael Tibbetts, MD
Phone: 239-542-2020
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Charleston, South Carolina 29414
Principal Investigator: Virgil Alfaro, MD
Phone: 843-763-4466
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Charlottesville, Virginia 22098
Principal Investigator: Steven Newman, MD
Phone: 434-243-2921
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Chicago, Illinois 60612
Principal Investigator: Peter W MacIntosh, MD
Phone: 312-355-4866
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303 East Superior Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Nicholas Volpe, MD
Phone: 312-472-3568
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Cleveland, Ohio 44195
Principal Investigator: Gregory Kosmorsky, DO
Phone: 216-444-1765
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Colorado Springs, Colorado
Principal Investigator: James K Luu, MD
Phone: 719-473-9595
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Durham, North Carolina 27710
Principal Investigator: Gospe Sidney, MD
Phone: 919-681-1569
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Glenview, Illinois 60026
Principal Investigator: John Pula, MD
Phone: 847-657-1750
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Houston, Texas 77025
Principal Investigator: Rosa Tang, MD, MPH, MBA
Phone: 713-480-0218
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Houston, Texas 77030
Principal Investigator: Andrew Lee, MD
Phone: 713-441-3958
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Lexington, Kentucky 40536
Principal Investigator: Padmaja Sudhakar, MD
Phone: 859-323-7452
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Loma Linda, California 92354
Principal Investigator: Michael E Rauser, MD
Phone: 909-558-2230
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8631 West 3rd Street
Los Angeles, California 90048
Los Angeles, California 90048
Principal Investigator: Swaraj Bose, MD
Phone: 310-469-9080
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Miami, Florida 33136
Principal Investigator: Byron Lam, MD
Phone: 305-482-4584
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New York, New York 10003
Principal Investigator: Rudrani Banik, MD
Phone: 212-979-4251
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New York, New York 10583
Principal Investigator: Marc Dinkin, MD
Phone: 646-962-4118
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Newark, New Jersey 07103
Principal Investigator: Larry Frohman, MD
Phone: 973-972-3173
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Oklahoma City, Oklahoma 73104
Principal Investigator: Anil Patel, MD
Phone: 405-271-6307
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Omaha, Nebraska 68105
Principal Investigator: Sachin Kedar, MD
Phone: 402-559-1853
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Palo Alto, California 94304
Principal Investigator: Yaping Joyce Liao, MD, PhD
Phone: 650-497-7846
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Pasadena, California 91105
Principal Investigator: Peter Quiros, MD
Phone: 626-817-4701
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Philadelphia, Pennsylvania 19104
Principal Investigator: Madhura Tamhankar, MD
Phone: 215-662-8038
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Raleigh, North Carolina 27607
Principal Investigator: Syndee Givre, MD, PhD
Phone: 919-782-3456
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Rochester, Minnesota 55905
Principal Investigator: John Chen, MD, PhD
Phone: 507-538-8119
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Rochester, New York 14642
Principal Investigator: Zoe Williams, MD
Phone: 585-273-1545
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Saint Louis, Missouri 63110
Principal Investigator: Gregory Van Stavern, MD
Phone: 314-286-2946
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Salt Lake City, Utah 84132
Principal Investigator: Bradley Katz, MD
Phone: 801-581-5142
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San Antonio, Texas
Principal Investigator: David K Scales, MD
Phone: 210-326-8057
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Sarasota, Florida 34239
Principal Investigator: Marc H Levy, MD
Phone: 941-921-5335
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Seattle, Washington 98104
Principal Investigator: Steven Hamilton, MD
Phone: 206-320-7121
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Seattle, Washington 98104
Principal Investigator: Courtney Francis, MD
Phone: 206-221-3121
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Stony Brook, New York 11794
Principal Investigator: Patrick Sibony, MD
Phone: 631-444-4511
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8 Macquarie Street
Sydney, New South Wales 2000
Sydney, New South Wales 2000
Principal Investigator: Clare Fraser, MD
Phone: +61 2 9382 7386
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750 East Adams Street
Syracuse, New York 13210
Syracuse, New York 13210
Principal Investigator: Louis Mejico, MD
Phone: 315-464-5013
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Waterbury, Connecticut 06708
Principal Investigator: Robert L Lesser, MD
Phone: 203-573-4897
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