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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02341560
Recruitment Status : Recruiting
First Posted : January 19, 2015
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Quark Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non Arteritic Anterior Ischemic Optic Neuropathy Drug: QPI-1007 Injection - 1.5 mg Drug: QPI-1007 Injection - 3.0 mg Other: Sham Injection Procedure Phase 2 Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Active Comparator: single dose or multiple dose
QPI-1007 Injection - 1.5 mg
Drug: QPI-1007 Injection - 1.5 mg
Other Name: QPI-1007

Active Comparator: single or multiple dose
QPI-1007 Injection - 3.0 mg
Drug: QPI-1007 Injection - 3.0 mg
Other Name: QPI-1007

Sham Comparator: Sham
Sham injection procedure
Other: Sham Injection Procedure
Sham Procedure
Other Name: Sham

Primary Outcome Measures :
  1. Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline through Month 12 ]
  2. Safety and tolerability of QPI-1007 as assessed by adverse events (AE), laboratory evaluations, ECGs, ophthalmic evaluations, slit lamp anterior/posterior examinations, intraocular pressure measurements, presence/absence of vitreous inflammation [ Time Frame: Baseline through Month 12 ]

Secondary Outcome Measures :
  1. Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye [ Time Frame: Day 1 through Month 12 ]
  2. Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry [ Time Frame: Day 1 through Month 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02341560

Contact: Robert Shopbell 510.402.4005

  Hide Study Locations
United States, Arkansas
University of Arkansas Medical Center, Jones Eye Institute Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Deborah Troillet, BS    501-686-5822   
Principal Investigator: Joseph Chacko, MD         
United States, California
Loma Linda University Eye Institute Recruiting
Loma Linda, California, United States, 92354
Contact: Raquel Hernandez    909-558-2168 ext 22170   
Contact: Anthoni Tampubolon    (909) 558-2230   
Principal Investigator: Michael E Rauser, MD         
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Yoon Hee Kim    323-865-6935   
Principal Investigator: Vivek Patel, MD         
NeuroEyeOrbit Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Lynn Childers    310-469-9080   
Principal Investigator: Swaraj Bose, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94303
Contact: Mariana Nunez    650-497-7846   
Principal Investigator: Yaping Joyce Liao, MD, PhD         
Unversity of California, Los Angeles (UCLA) Recruiting
Pasadena, California, United States, 91105
Contact: Rosia Mendoza, MA    626-817-4701   
Principal Investigator: Peter Quiros, MD         
United States, Colorado
University of Colorado Denver, Department of Neurology Recruiting
Aurora, Colorado, United States, 80045
Contact: Ruth Johnson    303-724-7885   
Contact: Nicole Gendelman   
Principal Investigator: Jeffery Bennett, MD         
Retina Consultants of Southern Colorado, PC Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: Brad Lovelace, CCRC    719-473-9595 ext 121   
Principal Investigator: James K Luu, MD         
United States, Connecticut
The Eye Care Group Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Sue Heaton, CRCC    203-573-4897   
Principal Investigator: Robert L Lesser, MD         
United States, Florida
Cape Coral Eye Center Recruiting
Cape Coral, Florida, United States, 33904
Contact: Kathleen Bellaire    239-542-2020 ext 2028   
Principal Investigator: Michael Tibbetts, MD         
University of Miami Miller School of Medicine/Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Potrya R Rosa    305-482-4584   
Principal Investigator: Byron Lam, MD         
Sarasota Retina Institute Recruiting
Sarasota, Florida, United States, 34239
Contact: Peggy Jelemensky    941-921-5335   
Principal Investigator: Marc H Levy, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Crystal Santillanes    312-472-3568   
Principal Investigator: Nicholas Volpe, MD         
University of Illinois at Chicago, Department of Ophthalmology (MC 648) Recruiting
Chicago, Illinois, United States, 60612
Contact: Roxana Ng    312-355-4866   
Principal Investigator: Peter W MacIntosh, MD         
NorthShore University Healthsystem Recruiting
Glenview, Illinois, United States, 60026
Contact: Mira Shiloach, MS, CCRP    847-657-1750   
Principal Investigator: John Pula, MD         
United States, Kentucky
University of Kentucky, Department of Neurology Recruiting
Lexington, Kentucky, United States, 40536
Contact: Dawn Baker    859-218-5055   
Principal Investigator: Padmaja Sudhakar, MD         
United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Lisa Azzaro, COA    443-849-8067   
Principal Investigator: Vivian Rismondo, MD         
Bethesda Neurology, LLC Recruiting
Bethesda, Maryland, United States, 20852
Contact: Riley Kastenhuber    301-540-2700   
Principal Investigator: David Katz, MD         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christopher Bayers    617-573-4459   
Principal Investigator: Dean Cestari, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 21118
Contact: Marissa Fiorello    617-414-8848   
Principal Investigator: Crandall Peeler, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Pamela Campbell    734-936-0138   
Principal Investigator: Lindsey De Lott, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Wendy Elasky    612-626-3056   
Principal Investigator: Michael Lee, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Heidi Rubin    507-538-8119   
Principal Investigator: John Chen, MD, PhD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Laura Adcock    314-286-2946   
Principal Investigator: Gregory Van Stavern, MD         
United States, Nebraska
University of Nebraska Medical Center and Truhlsen Eye Institute Recruiting
Omaha, Nebraska, United States, 68198
Contact: Kristi D Miller, COT    402-559-1853   
Principal Investigator: Sachin Kedar, MD         
United States, New Jersey
Rutgers, New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Olga Kavalenko    973-972-3173   
Principal Investigator: Larry Frohman, MD         
United States, New York
New York Eye and Ear Infirmary of Mount Sinai Recruiting
New York, New York, United States, 10003
Contact: Katy Tai, CRCC    212-979-4251   
Principal Investigator: Rudrani Banik, MD         
Cornell University School of Medicine Recruiting
New York, New York, United States, 10583
Contact: Susan Herder, PA    646-962-4118   
Principal Investigator: Marc Dinkin, MD         
University of Rochester, Flaum Eye Institute Recruiting
Rochester, New York, United States, 14642
Contact: Gary Gagarinas    585-276-4217   
Principal Investigator: Zoe Williams, MD         
State University of New York at Stony Brook Recruiting
Stony Brook, New York, United States, 11794
Contact: Ann Marie Lavoran, RN    631-444-4511   
Principal Investigator: Patrick Sibony, MD         
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Catherine Attanasio    315-464-5013   
Principal Investigator: Louis Mejico, MD         
United States, North Carolina
Duke University Eye Center Recruiting
Durham, North Carolina, United States, 27705
Contact: LaToya Greene    919-684-9072   
Contact: Ana Garcia-Turner    (919) 681-8873   
Principal Investigator: M. Tariq Bhatti, MD         
Raleigh Neurology Associates Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Tippi Hales, RN    919-782-3456   
Principal Investigator: Syndee Givre, MD, PhD         
United States, Ohio
Cleveland Clinic, Cole Eye Institute Recruiting
Cleveland, Ohio, United States, 44195
Contact: Heather Wojanowski    216-444-3735   
Principal Investigator: Gregory Kosmorsky, DO         
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73013
Contact: Amy Ford    405-271-6307   
Principal Investigator: Anil Patel, MD         
United States, Pennsylvania
University of Pennsylvania, Scheie Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joan DuPont    215-662-8038   
Contact: Judy Chen    (215) 662-8691   
Principal Investigator: Madhura Tamhankar, MD         
United States, South Carolina
Retina Consultants of Charleston Recruiting
Charleston, South Carolina, United States, 29414
Contact: Monica Rodriquez    843-822-7510   
Principal Investigator: Virgil Alfaro, MD         
United States, Texas
University of Houston, Neuro-Ophth of Texas Recruiting
Houston, Texas, United States, 77025
Contact: Alonso Prusmack    713-480-0218   
Principal Investigator: Rosa Tang, MD, MPH, MBA         
Houston Methodist Hospital, Blanton Eye Institute Recruiting
Houston, Texas, United States, 77030
Contact: Romeo Parada    713-441-3246   
Principal Investigator: Andrew Lee, MD         
Foresight Studies Recruiting
San Antonio, Texas, United States, 78240
Contact: Gladys Scales    210-326-8057   
Principal Investigator: David K Scales, MD         
United States, Utah
University of Utah John A. Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Susan Allman    801-581-5142   
Principal Investigator: Bradley Katz, MD         
United States, Virginia
University of Virginia Health Sciences Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Aston Leone, MPH    434-243-5737   
Principal Investigator: Steven Newman, MD         
United States, Washington
Swedish Medical Center, CO/NOCNW Recruiting
Seattle, Washington, United States, 98104
Contact: Caryl Tongco, BA    206-215-3565   
Principal Investigator: Steven Hamilton, MD         
University of Washington Department of Ophthalmology Recruiting
Seattle, Washington, United States, 98104
Contact: Ian Luttrell    206-221-3121   
Principal Investigator: Courtney Francis, MD         
Australia, New South Wales
Sydney Eye Hospital/Save Sight Institute Recruiting
Sydney, New South Wales, Australia, 2000
Contact: Jaclyn Bryant    +61 2 9382 7309   
Principal Investigator: Clare Fraser, MD         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Melanie Willoughby    +61 8 8222 2732   
Principal Investigator: Sumu Simon, MD         
Vision South Australia Recruiting
Kent Town, South Australia, Australia, 5267
Contact: Paul Stockle    8132.0494   
Principal Investigator: Celia Chen, MD         
Australia, Victoria
The Royal Victorian Eye and Ear Hospital Recruiting
Fitzroy, Victoria, Australia, 3002
Contact: Marios Constantinou    +61 3 9929 8666   
Principal Investigator: Neil Shuey, MD         
Australia, Western Australia
Royal Perth Hospital Recruiting
Perth, Western Australia, Australia, 6000
Contact: Linda Redman    +61-8 9224 1455   
Principal Investigator: Stephen Colley, MD         
China, Hunan
The Second Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410013
Contact: Luosheng Tang    +86 731 8529 5838   
Principal Investigator: Luosheng Tang, MD         
Peking University Eye Center, The Third Hospital Peking University. Recruiting
Beijing, China, 100191
Contact: Hongliang Dou    +86 10 8226 6563   
Principal Investigator: Hongliang Dou, MD         
Beijing Tongren Hospital, Capital Medical University Recruiting
Beijing, China, 100730
Contact: Ningli Wang    +86 10 5826 9920   
Principal Investigator: Ningli Wang, MD         
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Yong Zhong    +86 10 6915 6351   
Principal Investigator: Yong Zhong, MD         
Tianjin Eye Hospital Recruiting
Tianjin, China, 300000
Contact: Xiaolin HOU    0086 18722645296   
Principal Investigator: Quanhong Han, MD         
Universitätsmedizin d. Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Sabine Buchner    +49 6131 178355   
Principal Investigator: Katharina Bell, MD         
Universitätsklinikum Aachen-Augenklinik Recruiting
Aachen, Germany, 52074
Contact: Birgit Wauben    +49 241 80 88192   
Principal Investigator: Koutsonas Antonis, MD         
Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde Recruiting
Dresden, Germany, 01307
Contact: Yvonne Kliemt    +49 351 458 5491   
Principal Investigator: Dirk Sandner, MD         
Städtisches Klinikum Karlsruhe Withdrawn
Karlsruhe, Germany, 76133
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Adeline Adorf    +49 251 83 56048   
Principal Investigator: Nicole Eter, Prof MD         
Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde Recruiting
Regensburg, Germany, 93053
Contact: Sabine Brandi-Ruhle   
Principal Investigator: Maria-Andreea Gamulescu, Prof MD         
Universitäts-Augenklinik Tübingen Recruiting
Tubingen, Germany, 72076
Contact: Tanja Lengnink   
Principal Investigator: Helmut Wilhelm, Prof MD         
L V Prasad Eye Institute Recruiting
Hyderabad, Andhra Pradesh, India, 500034
Contact: Deepthi Gurram    91-7670866800   
Principal Investigator: Ramesh Kekunnaya, MD         
L V Prasad Eye Institute Recruiting
Visakhapatnam, Andhra Pradesh, India, 530040
Contact: Sachdeva Virender, MD    91 891-398-4555   
Principal Investigator: Sachdeva Virender, MD         
Sri Sankaradeva Nethralaya Recruiting
Guwahati, Assam, India, 781028
Contact: Bhaswati Talukdar    +91-7002354832      
Principal Investigator: Dipankar Das         
Narayana Nethralaya Recruiting
Bangalore, Karnataka,, India, 560010
Contact: Preethi Y Reddy    91-9036375925   
Principal Investigator: Krishna G Santhosh, MD         
PBMA'S H. V. Desai Eye Hospital Recruiting
Pune, Maharashtra, India, 411060
Contact: Hema Kale    +91-9970768768   
Principal Investigator: Hegade Atul Machindra, MD         
L V Prasad Eye Institute Recruiting
Bhubaneswar, Orissa, India, 751024
Contact: Krishna Gopal Panda    +91-674-3987108      
Principal Investigator: Vivekanand U Warkad, MD         
Sankara Nethralaya (Vision Research Foundation) Recruiting
Chennai, Tami Nadu, India, 600006
Contact: Kamatchi Ramaswamy    91 9840126173   
Principal Investigator: S Ambika, MD         
Aravind Eye Hospital Recruiting
Madurai, Tamil Nadu, India, 625020
Contact: Sivarama Subramanian    +91-7373708292   
Principal Investigator: S. Mahesh Kumar, MD         
Sanjay Gandhi Postgraduate Institute of Medical Sciences Recruiting
Lucknow, Uttar Pradesh, India, 226014
Contact: Pradhyumann P Singh, MD    91-7408890080   
Principal Investigator: Kumidini Sharma, MD         
ICARE Research Centre and Post Graduate Institute Recruiting
Noida, Uttar Pradesh, India, 201301
Contact: Shailendra Kumar    +91-9643201268   
Principal Investigator: Shahana Mazumdar         
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S. Recruiting
New Delhi, India, 110029
Contact: Sneha Aggarwal    91-9999211330   
Principal Investigator: Rohit Saxena, MD         
Datta Meghe Institute of Medical Sciences Recruiting
Wardha, India, 442005
Contact: Seema Bhagat    +91-9657891187   
Principal Investigator: Sachin Daighavane, MD         
Meir Medical Center Withdrawn
Kfar Saba, HaMerkaz, Israel, 4428164
Hadassah Medical Center Recruiting
Jerusalem, Yerushalayim, Israel, 9112001
Contact: Michal Shpigel    +972544575921   
Principal Investigator: Shlomo Dotan, MD         
Soroka University Medical Center Recruiting
Beer-Sheva, Israel, 84101
Contact: Tal Twito    972-52-4373127   
Principal Investigator: Marina Shneck, MD         
Bnai Zion Medical Center Recruiting
Haifa, Israel, 31048
Contact: Dalia Nissim    972-54-2204563   
Principal Investigator: Nitza Goldenberg Cohen, MD         
Rabin Medical Center, Belinson Campus Recruiting
Petach-Tikva, Israel, 49100
Contact: Vivi Dagan    972-3-9377199   
Principal Investigator: Hadas Kalish, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel, 76100
Contact: Lihi Geller Eliyahu    972-8-9441691   
Principal Investigator: Hanna Leiba, MD         
The Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Contact: Einat Yeshurun    972-3-6974361   
Principal Investigator: Ainat Klein, MD         
The Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Rinat Cohen Rashty    972-3-5302877   
Principal Investigator: Ruth Huna-Baron, MD         
AOU Policlinico S. Orsola-Malpighi Recruiting
Bologna, Italy, 40139
Contact: Chiara P Cavalletti    +39 051-6362835   
Principal Investigator: Antonio P Ciardella, MD         
AOU Careggi Recruiting
Firenze, Italy, 50134
Contact: Ilaria Biagini   
Principal Investigator: Gianni Virgili, MD         
Scientific Institute Auxologico Italiano Recruiting
Milano, Italy
Contact: Claudia Mainetti   
Principal Investigator: Stefania Bianchi-Marzoli, MD         
Scientific institute San Raffaele Recruiting
Milano, Italy
Contact: Filippo Galante    +39 02 26436212   
Principal Investigator: Francesco Bandello, MD         
University Eye Clinic Recruiting
Parma, Italy, 43100
Contact: Sally L Williams   
Principal Investigator: Arturo Carta, MD         
PO C. Sperino - ASLTO1, Università di Torino Withdrawn
Torino, Italy, 10122
Singapore National Eye Centre Recruiting
Singapore, Singapore, 168751
Contact: Marlina Tay    +65 6322 4529   
Principal Investigator: Sharon Tow, MD         
Tan Tock Seng Hospital, Department of Ophthalmology Recruiting
Singapore, Singapore, 308433
Contact: Shir Lee Long    +65 6357 8388   
Principal Investigator: Chee Fang Chin, MD         
Sponsors and Collaborators
Quark Pharmaceuticals
Study Director: Sharon Klier, M.D. Quark Pharmaceuticals

Responsible Party: Quark Pharmaceuticals Identifier: NCT02341560     History of Changes
Other Study ID Numbers: QRK207
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: April 2018

Keywords provided by Quark Pharmaceuticals:

Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases