Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
- Conditions
- Non Arteritic Anterior Ischemic Optic Neuropathy
- Interventions
- Drug: QPI-1007 Injection - 1.5 mgDrug: QPI-1007 Injection - 3.0 mgOther: Sham Injection Procedure
- Registration Number
- NCT02341560
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 732
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single dose or multiple dose QPI-1007 Injection - 1.5 mg QPI-1007 Injection - 1.5 mg single or multiple dose QPI-1007 Injection - 3.0 mg QPI-1007 Injection - 3.0 mg Sham Sham Injection Procedure Sham injection procedure
- Primary Outcome Measures
Name Time Method Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) Baseline through Month 12 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 Baseline through Month 12
- Secondary Outcome Measures
Name Time Method Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye Day 1 through Month 12 Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry Day 1 through Month 12
Trial Locations
- Locations (83)
Rutgers, New Jersey Medical School
🇺🇸Newark, New Jersey, United States
Loma Linda University Eye Institute
🇺🇸Loma Linda, California, United States
Datta Meghe Institute of Medical Sciences
🇮🇳Wardha, India
University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Houston, Neuro-Ophth of Texas
🇺🇸Houston, Texas, United States
Swedish Medical Center, CO/NOCNW
🇺🇸Seattle, Washington, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
University of Pennsylvania, Scheie Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
NorthShore University Healthsystem
🇺🇸Glenview, Illinois, United States
Stanford University
🇺🇸Palo Alto, California, United States
Cleveland Clinic, Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Retina Consultants of Charleston
🇺🇸Charleston, South Carolina, United States
Cornell University School of Medicine
🇺🇸New York, New York, United States
NeuroEyeOrbit Institute
🇺🇸Los Angeles, California, United States
University of Illinois at Chicago, Department of Ophthalmology (MC 648)
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Cape Coral Eye Center
🇺🇸Cape Coral, Florida, United States
ICARE Research Centre and Post Graduate Institute
🇮🇳Noida, Uttar Pradesh, India
Tan Tock Seng Hospital, Department of Ophthalmology
🇸🇬Singapore, Singapore
State University of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Raleigh Neurology Associates
🇺🇸Raleigh, North Carolina, United States
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
🇮🇳New Delhi, India
Bnai Zion Medical Center
🇮🇱Haifa, Israel
Soroka University Medical Center
🇮🇱Beer-Sheva, Israel
Rabin Medical Center, Belinson Campus
🇮🇱Petach-Tikva, Israel
The Eye Care Group
🇺🇸Waterbury, Connecticut, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Beijing Tongren Hospital, Capital Medical University
🇨🇳Beijing, China
Foresight Studies
🇺🇸San Antonio, Texas, United States
Sankara Nethralaya (Vision Research Foundation)
🇮🇳Chennai, Tami Nadu, India
AOU Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Kaplan Medical Center
🇮🇱Rehovot, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
PBMA'S H. V. Desai Eye Hospital
🇮🇳Pune, Maharashtra, India
Scientific Institute Auxologico Italiano
🇮🇹Milano, Italy
Singapore National Eye Centre
🇸🇬Singapore, Singapore
AOU Careggi
🇮🇹Firenze, Italy
The Chaim Sheba Medical Center
🇮🇱Tel-Hashomer, Israel
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Peking University Eye Center, The Third Hospital Peking University.
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Tianjin Eye Hospital
🇨🇳Tianjin, China
Aravind Eye Hospital
🇮🇳Madurai, Tamil Nadu, India
University of Southern California
🇺🇸Los Angeles, California, United States
University of Utah John A. Moran Eye Center
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Dean McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Universitäts-Augenklinik Tübingen
🇩🇪Tubingen, Germany
The Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Bethesda Neurology, LLC
🇺🇸Bethesda, Maryland, United States
University of Colorado Denver, Department of Neurology
🇺🇸Aurora, Colorado, United States
University of Nebraska Medical Center and Truhlsen Eye Institute
🇺🇸Omaha, Nebraska, United States
University of Arkansas Medical Center, Jones Eye Institute
🇺🇸Little Rock, Arkansas, United States
Unversity of California, Los Angeles (UCLA)
🇺🇸Pasadena, California, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
University of Kentucky, Department of Neurology
🇺🇸Lexington, Kentucky, United States
New York Eye and Ear Infirmary of Mount Sinai
🇺🇸New York, New York, United States
University of Rochester, Flaum Eye Institute
🇺🇸Rochester, New York, United States
University of Virginia Health Sciences Center
🇺🇸Charlottesville, Virginia, United States
L V Prasad Eye Institute
🇮🇳Bhubaneswar, Orissa, India
Universitätsklinikum Münster
🇩🇪Münster, Germany
Narayana Nethralaya
🇮🇳Bangalore, Karnataka,, India
Sri Sankaradeva Nethralaya
🇮🇳Guwahati, Assam, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳Lucknow, Uttar Pradesh, India
Scientific institute San Raffaele
🇮🇹Milano, Italy
University Eye Clinic
🇮🇹Parma, Italy
Houston Methodist Hospital, Blanton Eye Institute
🇺🇸Houston, Texas, United States
Retina Consultants of Southern Colorado, PC
🇺🇸Colorado Springs, Colorado, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Vision South Australia
🇦🇺Kent Town, South Australia, Australia
University of Washington Department of Ophthalmology
🇺🇸Seattle, Washington, United States
Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
🇩🇪Regensburg, Germany
Sydney Eye Hospital/Save Sight Institute
🇦🇺Sydney, New South Wales, Australia
Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
🇩🇪Dresden, Germany
The Royal Victorian Eye and Ear Hospital
🇦🇺Fitzroy, Victoria, Australia
Universitätsklinikum Aachen-Augenklinik
🇩🇪Aachen, Germany
Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Rheinland-Pfalz, Germany