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

NCT02341560 | Terminated Phase 2 DMC

• 1 other identifier: QRK207
• Study Type: interventional
• Target: 732
• Locations: 8 countries
• Sites: 85

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.

Conditions

Non Arteritic Anterior Ischemic Optic Neuropathy

Keywords

NAION

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (3)

single dose or multiple dose

ACTIVE COMPARATOR

QPI-1007 Injection - 1.5 mg

Drug: QPI-1007 Injection - 1.5 mg

single or multiple dose

ACTIVE COMPARATOR

QPI-1007 Injection - 3.0 mg

Drug: QPI-1007 Injection - 3.0 mg

Sham

SHAM COMPARATOR

Sham injection procedure

Other: Sham Injection Procedure

Interventions

QPI-1007 Injection - 1.5 mg DRUG

Also known as: QPI-1007

single dose or multiple dose

QPI-1007 Injection - 3.0 mg DRUG

Also known as: QPI-1007

single or multiple dose

Sham Injection Procedure OTHER

Sham Procedure

Also known as: Sham

Sham

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Quark Pharmaceuticals: lead

Study Sites (85)

University of Arkansas Medical Center, Jones Eye Institute

Little Rock, Arkansas, 72205, United States

Location

Loma Linda University Eye Institute

Loma Linda, California, 92354, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

NeuroEyeOrbit Institute

Los Angeles, California, 90048, United States

Location

Stanford University

Palo Alto, California, 94303, United States

Location

Unversity of California, Los Angeles (UCLA)

Pasadena, California, 91105, United States

Location

University of Colorado Denver, Department of Neurology

Aurora, Colorado, 80045, United States

Location

Retina Consultants of Southern Colorado, PC

Colorado Springs, Colorado, 80909, United States

Location

The Eye Care Group

Waterbury, Connecticut, 06708, United States

Location

Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

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

Miami, Florida, 33136, United States

Location

Sarasota Retina Institute

Sarasota, Florida, 34239, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

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

Chicago, Illinois, 60612, United States

Location

NorthShore University Healthsystem

Glenview, Illinois, 60026, United States

Location

University of Kentucky, Department of Neurology

Lexington, Kentucky, 40536, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

Bethesda Neurology, LLC

Bethesda, Maryland, 20852, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Boston Medical Center

Boston, Massachusetts, 21118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center and Truhlsen Eye Institute

Omaha, Nebraska, 68198, United States

Location

Rutgers, New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10003, United States

Location

Cornell University School of Medicine

New York, New York, 10583, United States

Location

University of Rochester, Flaum Eye Institute

Rochester, New York, 14642, United States

Location

State University of New York at Stony Brook

Stony Brook, New York, 11794, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke University Eye Center

Durham, North Carolina, 27705, United States

Location

Raleigh Neurology Associates

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic, Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Dean McGee Eye Institute

Oklahoma City, Oklahoma, 73013, United States

Location

University of Pennsylvania, Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Retina Consultants of Charleston

Charleston, South Carolina, 29414, United States

Location

University of Houston, Neuro-Ophth of Texas

Houston, Texas, 77025, United States

Location

Houston Methodist Hospital, Blanton Eye Institute

Houston, Texas, 77030, United States

Location

Foresight Studies

San Antonio, Texas, 78240, United States

Location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Health Sciences Center

Charlottesville, Virginia, 22908, United States

Location

Swedish Medical Center, CO/NOCNW

Seattle, Washington, 98104, United States

Location

University of Washington Department of Ophthalmology

Seattle, Washington, 98104, United States

Location

Sydney Eye Hospital/Save Sight Institute

Sydney, New South Wales, 2000, Australia

Location

Vision South Australia

Kent Town, South Australia, 5267, Australia

Location

The Royal Victorian Eye and Ear Hospital

Fitzroy, Victoria, 3002, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Peking University Eye Center, The Third Hospital Peking University.

Beijing, 100191, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Tianjin Eye Hospital

Tianjin, 300000, China

Location

Universitätsmedizin d. Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Aachen-Augenklinik

Aachen, 52074, Germany

Location

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

Dresden, 01307, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde

Regensburg, 93053, Germany

Location

Universitäts-Augenklinik Tübingen

Tübingen, 72076, Germany

Location

L V Prasad Eye Institute

Hyderabad, Andhra Pradesh, 500034, India

Location

L V Prasad Eye Institute

Visakhapatnam, Andhra Pradesh, 530040, India

Location

Sri Sankaradeva Nethralaya

Guwahati, Assam, 781028, India

Location

Narayana Nethralaya

Bangalore, Karnataka, 560010, India

Location

PBMA'S H. V. Desai Eye Hospital

Pune, Maharashtra, 411060, India

Location

L V Prasad Eye Institute

Bhubaneswar, Odisha, 751024, India

Location

Sankara Nethralaya (Vision Research Foundation)

Chennai, Tami Nadu, 600006, India

Location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625020, India

Location

Sanjay Gandhi Postgraduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

ICARE Research Centre and Post Graduate Institute

Noida, Uttar Pradesh, 201301, India

Location

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

New Delhi, 110029, India

Location

Datta Meghe Institute of Medical Sciences

Wardha, 442005, India

Location

Hadassah Medical Center

Jerusalem, Jerusalem, 9112001, Israel

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Rabin Medical Center, Belinson Campus

Petah Tikva, 49100, Israel

Location

Kaplan Medical Center

Rehovot, 76100, Israel

Location

The Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

AOU Policlinico S. Orsola-Malpighi

Bologna, 40139, Italy

Location

AOU Careggi

Florence, 50134, Italy

Location

Scientific Institute Auxologico Italiano

Milan, Italy

Location

Scientific institute San Raffaele

Milan, Italy

Location

University Eye Clinic

Parma, 43100, Italy

Location

Singapore National Eye Centre

Singapore, 168751, Singapore

Location

Tan Tock Seng Hospital, Department of Ophthalmology

Singapore, 308433, Singapore

Location

Related Publications (1)

• 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.

  PMID: 30194931 DERIVED

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sharon Klier, M.D.

  Quark Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 19, 2015
• Study Start: February 24, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 20, 2020

Record last verified: 2019-07

Locations

AU (4); DE (6); IN (12); IL (7); SG (2); IT (5); CN (5); US (44)