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

July 16, 2020 updated by: Quark Pharmaceuticals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

732

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Sydney Eye Hospital/Save Sight Institute
    • South Australia
      • Kent Town, South Australia, Australia, 5267
        • Vision South Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3002
        • The Royal Victorian Eye and Ear Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100191
        • Peking University Eye Center, The Third Hospital Peking University.
      • Beijing, China, 100730
        • Beijing Tongren Hospital, Capital Medical University
      • Tianjin, China, 300000
        • TianJin eye hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Second Xiangya Hospital of Central South University
  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen-Augenklinik
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
      • Münster, Germany, 48149
        • Universitatsklinikum Munster
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
      • Tubingen, Germany, 72076
        • Universitäts-Augenklinik Tübingen
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
  • India
      • New Delhi, India, 110029
        • Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
      • Wardha, India, 442005
        • Datta Meghe Institute of Medical Sciences
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • L V Prasad Eye Institute
      • Visakhapatnam, Andhra Pradesh, India, 530040
        • L V Prasad Eye Institute
    • Assam
      • Guwahati, Assam, India, 781028
        • Sri Sankaradeva Nethralaya
    • Karnataka,
      • Bangalore, Karnataka,, India, 560010
        • Narayana Nethralaya
    • Maharashtra
      • Pune, Maharashtra, India, 411060
        • PBMA'S H. V. Desai Eye Hospital
    • Orissa
      • Bhubaneswar, Orissa, India, 751024
        • L V Prasad Eye Institute
    • Tami Nadu
      • Chennai, Tami Nadu, India, 600006
        • Sankara Nethralaya (Vision Research Foundation)
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Aravind Eye Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226014
        • Sanjay Gandhi Postgraduate Institute of Medical Sciences
      • Noida, Uttar Pradesh, India, 201301
        • ICARE Research Centre and Post Graduate Institute
  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Petach-Tikva, Israel, 49100
        • Rabin Medical Center, Belinson Campus
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel-Aviv, Israel, 64239
        • The Tel-Aviv Sourasky Medical Center
      • Tel-Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9112001
        • Hadassah Medical Center
  • Italy
      • Bologna, Italy, 40139
        • AOU Policlinico S. Orsola-Malpighi
      • Firenze, Italy, 50134
        • AOU Careggi
      • Milano, Italy
        • Scientific Institute Auxologico Italiano
      • Milano, Italy
        • Scientific Institute San Raffaele
      • Parma, Italy, 43100
        • University Eye Clinic
  • Singapore
      • Singapore, Singapore, 168751
        • Singapore National Eye Centre
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital, Department of Ophthalmology
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas Medical Center, Jones Eye Institute
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Eye Institute
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • NeuroEyeOrbit Institute
      • Palo Alto, California, United States, 94303
        • Stanford University
      • Pasadena, California, United States, 91105
        • Unversity of California, Los Angeles (UCLA)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, Department of Neurology
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado, PC
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • The Eye Care Group
    • Florida
      • Cape Coral, Florida, United States, 33904
        • Cape Coral Eye Center
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Retina Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago, Department of Ophthalmology (MC 648)
      • Glenview, Illinois, United States, 60026
        • NorthShore University HealthSystem
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky, Department of Neurology
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, United States, 20852
        • Bethesda Neurology, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary
      • Boston, Massachusetts, United States, 21118
        • Boston Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center and Truhlsen Eye Institute
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Rutgers, New Jersey Medical School
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary of Mount Sinai
      • New York, New York, United States, 10583
        • Cornell University School of Medicine
      • Rochester, New York, United States, 14642
        • University of Rochester, Flaum Eye Institute
      • Stony Brook, New York, United States, 11794
        • State University of New York at Stony Brook
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Eye Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic, Cole Eye Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73013
        • Dean McGee Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania, Scheie Eye Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Retina Consultants of Charleston
    • Texas
      • Houston, Texas, United States, 77025
        • University of Houston, Neuro-Ophth of Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital, Blanton Eye Institute
      • San Antonio, Texas, United States, 78240
        • Foresight Studies
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah John A. Moran Eye Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health Sciences Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center, CO/NOCNW
      • Seattle, Washington, United States, 98104
        • University of Washington Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single dose or multiple dose
QPI-1007 Injection - 1.5 mg
Drug: QPI-1007 Injection - 1.5 mg
Other Names:
  • QPI-1007
Active Comparator: single or multiple dose
QPI-1007 Injection - 3.0 mg
Drug: QPI-1007 Injection - 3.0 mg
Other Names:
  • QPI-1007
Sham Comparator: Sham
Sham injection procedure
Other: Sham Injection Procedure
Sham Procedure
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline through Month 12
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
Time Frame: Baseline through Month 12
Baseline through Month 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quark Pharmaceuticals

Investigators

  • Study Director: Sharon Klier, M.D., Quark Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2016

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 13, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 16, 2020

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QRK207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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