Non Arteritic Anterior Ischemic Optic Neuropathy Clinical Trial
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)
| Verified date | July 2019 |
| Source | Quark Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 732 |
| Est. completion date | July 1, 2019 |
| Est. primary completion date | July 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | The Royal Victorian Eye and Ear Hospital | Fitzroy | Victoria |
| Australia | Vision South Australia | Kent Town | South Australia |
| Australia | Royal Perth Hospital | Perth | Western Australia |
| Australia | Sydney Eye Hospital/Save Sight Institute | Sydney | New South Wales |
| China | Beijing Tongren Hospital, Capital Medical University | Beijing | |
| China | Peking Union Medical College Hospital | Beijing | |
| China | Peking University Eye Center, The Third Hospital Peking University. | Beijing | |
| China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
| China | Tianjin Eye Hospital | Tianjin | |
| Germany | Universitätsklinikum Aachen-Augenklinik | Aachen | |
| Germany | Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde | Dresden | |
| Germany | Universitätsmedizin d. Johannes Gutenberg-Universität Mainz | Mainz | Rheinland-Pfalz |
| Germany | Universitätsklinikum Münster | Münster | |
| Germany | Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde | Regensburg | |
| Germany | Universitäts-Augenklinik Tübingen | Tubingen | |
| India | Narayana Nethralaya | Bangalore | Karnataka, |
| India | L V Prasad Eye Institute | Bhubaneswar | Orissa |
| India | Sankara Nethralaya (Vision Research Foundation) | Chennai | Tami Nadu |
| India | Sri Sankaradeva Nethralaya | Guwahati | Assam |
| India | L V Prasad Eye Institute | Hyderabad | Andhra Pradesh |
| India | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Lucknow | Uttar Pradesh |
| India | Aravind Eye Hospital | Madurai | Tamil Nadu |
| India | Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S. | New Delhi | |
| India | ICARE Research Centre and Post Graduate Institute | Noida | Uttar Pradesh |
| India | PBMA'S H. V. Desai Eye Hospital | Pune | Maharashtra |
| India | L V Prasad Eye Institute | Visakhapatnam | Andhra Pradesh |
| India | Datta Meghe Institute of Medical Sciences | Wardha | |
| Israel | Soroka University Medical Center | Beer-Sheva | |
| Israel | Bnai Zion Medical Center | Haifa | |
| Israel | Hadassah Medical Center | Jerusalem | Yerushalayim |
| Israel | Rabin Medical Center, Belinson Campus | Petach-Tikva | |
| Israel | Kaplan Medical Center | Rehovot | |
| Israel | The Tel-Aviv Sourasky Medical Center | Tel-Aviv | |
| Israel | The Chaim Sheba Medical Center | Tel-Hashomer | |
| Italy | AOU Policlinico S. Orsola-Malpighi | Bologna | |
| Italy | AOU Careggi | Firenze | |
| Italy | Scientific Institute Auxologico Italiano | Milano | |
| Italy | Scientific institute San Raffaele | Milano | |
| Italy | University Eye Clinic | Parma | |
| Singapore | Singapore National Eye Centre | Singapore | |
| Singapore | Tan Tock Seng Hospital, Department of Ophthalmology | Singapore | |
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University of Colorado Denver, Department of Neurology | Aurora | Colorado |
| United States | Greater Baltimore Medical Center | Baltimore | Maryland |
| United States | Bethesda Neurology, LLC | Bethesda | Maryland |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Massachusetts Eye and Ear Infirmary | Boston | Massachusetts |
| United States | Cape Coral Eye Center | Cape Coral | Florida |
| United States | Retina Consultants of Charleston | Charleston | South Carolina |
| United States | University of Virginia Health Sciences Center | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Illinois at Chicago, Department of Ophthalmology (MC 648) | Chicago | Illinois |
| United States | Cleveland Clinic, Cole Eye Institute | Cleveland | Ohio |
| United States | Retina Consultants of Southern Colorado, PC | Colorado Springs | Colorado |
| United States | Duke University Eye Center | Durham | North Carolina |
| United States | NorthShore University Healthsystem | Glenview | Illinois |
| United States | Houston Methodist Hospital, Blanton Eye Institute | Houston | Texas |
| United States | University of Houston, Neuro-Ophth of Texas | Houston | Texas |
| United States | University of Kentucky, Department of Neurology | Lexington | Kentucky |
| United States | University of Arkansas Medical Center, Jones Eye Institute | Little Rock | Arkansas |
| United States | Loma Linda University Eye Institute | Loma Linda | California |
| United States | NeuroEyeOrbit Institute | Los Angeles | California |
| United States | University of Southern California | Los Angeles | California |
| United States | University of Miami Miller School of Medicine/Bascom Palmer Eye Institute | Miami | Florida |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Cornell University School of Medicine | New York | New York |
| United States | New York Eye and Ear Infirmary of Mount Sinai | New York | New York |
| United States | Rutgers, New Jersey Medical School | Newark | New Jersey |
| United States | Dean McGee Eye Institute | Oklahoma City | Oklahoma |
| United States | University of Nebraska Medical Center and Truhlsen Eye Institute | Omaha | Nebraska |
| United States | Stanford University | Palo Alto | California |
| United States | Unversity of California, Los Angeles (UCLA) | Pasadena | California |
| United States | University of Pennsylvania, Scheie Eye Institute | Philadelphia | Pennsylvania |
| United States | Raleigh Neurology Associates | Raleigh | North Carolina |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester, Flaum Eye Institute | Rochester | New York |
| United States | Washington University in St. Louis | Saint Louis | Missouri |
| United States | University of Utah John A. Moran Eye Center | Salt Lake City | Utah |
| United States | Foresight Studies | San Antonio | Texas |
| United States | Sarasota Retina Institute | Sarasota | Florida |
| United States | Swedish Medical Center, CO/NOCNW | Seattle | Washington |
| United States | University of Washington Department of Ophthalmology | Seattle | Washington |
| United States | State University of New York at Stony Brook | Stony Brook | New York |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | The Eye Care Group | Waterbury | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Quark Pharmaceuticals |
United States, Australia, China, Germany, India, Israel, Italy, Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) | Baseline through Month 12 | ||
| Primary | 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 | Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye | Day 1 through Month 12 | ||
| Secondary | Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry | Day 1 through Month 12 |