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Non Arteritic Anterior Ischemic Optic NeuropathyPhase 2/3NCT02341560

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

A Phase 2/3 study testing QPI-1007 Injection - 1.5 mg and QPI-1007 Injection - 3.0 mg in people with Non Arteritic Anterior Ischemic Optic Neuropathy, run by Quark Pharmaceuticals at 85 sites in 8 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 years
What is being tested?
QPI-1007 Injection - 1.5 mg and QPI-1007 Injection - 3.0 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
732 participants
Where
85 sitesin 8 countries
Study dates
24 Feb 2016to 1 Jul 2019
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

85 sites in 8 countries.

85 sites in 8 countries

United States44 sites

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • University of Colorado Denver, Department of Neurology

    Aurora, Colorado, 80045

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Bethesda Neurology, LLC

    Bethesda, Maryland, 20852

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 21118

  • Cape Coral Eye Center

    Cape Coral, Florida, 33904

  • Retina Consultants of Charleston

    Charleston, South Carolina, 29414

  • University of Virginia Health Sciences Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois at Chicago, Department of Ophthalmology (MC 648)

    Chicago, Illinois, 60612

  • Cleveland Clinic, Cole Eye Institute

    Cleveland, Ohio, 44195

  • Retina Consultants of Southern Colorado, PC

    Colorado Springs, Colorado, 80909

  • Duke University Eye Center

    Durham, North Carolina, 27705

  • NorthShore University Healthsystem

    Glenview, Illinois, 60026

  • University of Houston, Neuro-Ophth of Texas

    Houston, Texas, 77025

  • Houston Methodist Hospital, Blanton Eye Institute

    Houston, Texas, 77030

  • University of Kentucky, Department of Neurology

    Lexington, Kentucky, 40536

  • University of Arkansas Medical Center, Jones Eye Institute

    Little Rock, Arkansas, 72205

  • Loma Linda University Eye Institute

    Loma Linda, California, 92354

  • University of Southern California

    Los Angeles, California, 90033

  • NeuroEyeOrbit Institute

    Los Angeles, California, 90048

  • University of Miami Miller School of Medicine/Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • New York Eye and Ear Infirmary of Mount Sinai

    New York, New York, 10003

  • Cornell University School of Medicine

    New York, New York, 10583

  • Rutgers, New Jersey Medical School

    Newark, New Jersey, 07103

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73013

  • University of Nebraska Medical Center and Truhlsen Eye Institute

    Omaha, Nebraska, 68198

  • Stanford University

    Palo Alto, California, 94303

  • Unversity of California, Los Angeles (UCLA)

    Pasadena, California, 91105

  • University of Pennsylvania, Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester, Flaum Eye Institute

    Rochester, New York, 14642

  • University of Utah John A. Moran Eye Center

    Salt Lake City, Utah, 84132

  • Foresight Studies

    San Antonio, Texas, 78240

  • Sarasota Retina Institute

    Sarasota, Florida, 34239

  • Swedish Medical Center, CO/NOCNW

    Seattle, Washington, 98104

  • University of Washington Department of Ophthalmology

    Seattle, Washington, 98104

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • State University of New York at Stony Brook

    Stony Brook, New York, 11794

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • The Eye Care Group

    Waterbury, Connecticut, 06708

Other trials in United States

India12 sites

  • Narayana Nethralaya

    Bangalore, Karnataka, 560010

  • L V Prasad Eye Institute

    Bhubaneswar, Odisha, 751024

  • Sankara Nethralaya (Vision Research Foundation)

    Chennai, Tami Nadu, 600006

  • Sri Sankaradeva Nethralaya

    Guwahati, Assam, 781028

  • L V Prasad Eye Institute

    Hyderabad, Andhra Pradesh, 500034

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

  • Aravind Eye Hospital

    Madurai, Tamil Nadu, 625020

  • Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.

    New Delhi, 110029

  • ICARE Research Centre and Post Graduate Institute

    Noida, Uttar Pradesh, 201301

  • PBMA'S H. V. Desai Eye Hospital

    Pune, Maharashtra, 411060

  • L V Prasad Eye Institute

    Visakhapatnam, Andhra Pradesh, 530040

  • Datta Meghe Institute of Medical Sciences

    Wardha, 442005

Other trials in India

Israel7 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Rabin Medical Center, Belinson Campus

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot, 76100

  • The Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Germany6 sites

  • Universitätsklinikum Aachen-Augenklinik

    Aachen, 52074

  • Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde

    Dresden, 01307

  • Universitätsmedizin d. Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde

    Regensburg, 93053

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076

Other trials in Germany

China5 sites

  • Peking University Eye Center, The Third Hospital Peking University.

    Beijing, 100191

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, 100730

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • Tianjin Eye Hospital

    Tianjin, 300000

Other trials in China

Italy5 sites

  • AOU Policlinico S. Orsola-Malpighi

    Bologna, 40139

  • AOU Careggi

    Florence, 50134

  • Scientific Institute Auxologico Italiano

    Milan

  • Scientific institute San Raffaele

    Milan

  • University Eye Clinic

    Parma, 43100

Other trials in Italy

Australia4 sites

  • The Royal Victorian Eye and Ear Hospital

    Fitzroy, Victoria, 3002

  • Vision South Australia

    Kent Town, South Australia, 5267

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Sydney Eye Hospital/Save Sight Institute

    Sydney, New South Wales, 2000

Other trials in Australia

Singapore2 sites

  • Singapore National Eye Centre

    Singapore, 168751

  • Tan Tock Seng Hospital, Department of Ophthalmology

    Singapore, 308433

Other trials in Singapore

About this study

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)

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.

Read the 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.

Being tested
QPI-1007 Injection - 1.5 mg, QPI-1007 Injection - 3.0 mg, Sham Injection Procedure
Keywords
NAION
Medical subject headings
Optic Neuropathy, Ischemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QPI-1007 Injection - 1.5 mgDrug

    Also called QPI-1007

  • QPI-1007 Injection - 3.0 mgDrug

    Also called QPI-1007

  • Sham Injection ProcedureOther

    Also called Sham

    Sham Procedure

Study groups in NCT02341560
Study groupRoleWhat they receive
single dose or multiple doseActive comparatorQPI-1007 Injection - 1.5 mg
Receives: Drug: QPI-1007 Injection - 1.5 mg
single or multiple doseActive comparatorQPI-1007 Injection - 3.0 mg
Receives: Drug: QPI-1007 Injection - 3.0 mg
ShamSham comparatorSham injection procedure
Receives: Other: Sham Injection Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)

    Measured: 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

    Measured: Baseline through Month 12

Secondary outcomes (2)

  1. Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye

    Measured: Day 1 through Month 12

  2. Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry

    Measured: Day 1 through Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2015 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion1 Jul 2019
  4. Study completion1 Jul 2019

Why it stopped: An interim analysis did not warrant to continue enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
732 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02341560
Sponsor's protocol ID
QRK207
Status last verified
Jul 2019
First submitted
13 Jan 2015
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Woods B, Szanto D, Wang JK, Erekat A, Golden A, Garvin MK, Williams ZR, Linton EF, Kardon RH, Kupersmith MJ. Early Optic Nerve Head Swelling Rate Is Associated with Worsening of Visual Outcomes in Nonarteritic Anterior Ischemic Optic Neuropathy. Ophthalmology. 2026 May 18:S0161-6420(26)00360-X. doi: 10.1016/j.ophtha.2026.05.013. Online ahead of print.

    PubMed 42155674

  • Davis JL. The Blunt End: Surgical Challenges of Gene Therapy for Inherited Retinal Diseases. Am J Ophthalmol. 2018 Dec;196:xxv-xxix. doi: 10.1016/j.ajo.2018.08.038. Epub 2018 Sep 5.

    PubMed 30194931

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing QPI-1007 Injection - 1.5 mg and QPI-1007 Injection - 3.0 mg in people with Non Arteritic Anterior Ischemic Optic Neuropathy, run by Quark Pharmaceuticals at 85 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, India, Israel, Germany, China and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: An interim analysis did not warrant to continue enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA) (time frame: Baseline through Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02341560, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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