Back to resultsPhase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Primary Purpose
Non Arteritic Anterior Ischemic Optic Neuropathy
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
QPI-1007 Injection - 1.5 mg
QPI-1007 Injection - 3.0 mg
Sham Injection Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Non Arteritic Anterior Ischemic Optic Neuropathy focused on measuring NAION
Eligibility Criteria
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
Sites / Locations
- University of Arkansas Medical Center, Jones Eye Institute
- Loma Linda University Eye Institute
- University of Southern California
- NeuroEyeOrbit Institute
- Stanford University
- Unversity of California, Los Angeles (UCLA)
- University of Colorado Denver, Department of Neurology
- Retina Consultants of Southern Colorado, PC
- The Eye Care Group
- Cape Coral Eye Center
- University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
- Sarasota Retina Institute
- Northwestern University
- University of Illinois at Chicago, Department of Ophthalmology (MC 648)
- NorthShore University Healthsystem
- University of Kentucky, Department of Neurology
- Greater Baltimore Medical Center
- Bethesda Neurology, LLC
- Massachusetts Eye and Ear Infirmary
- Boston Medical Center
- University of Michigan
- University of Minnesota
- Mayo Clinic
- Washington University in St. Louis
- University of Nebraska Medical Center and Truhlsen Eye Institute
- Rutgers, New Jersey Medical School
- New York Eye and Ear Infirmary of Mount Sinai
- Cornell University School of Medicine
- University of Rochester, Flaum Eye Institute
- State University of New York at Stony Brook
- SUNY Upstate Medical University
- Duke University Eye Center
- Raleigh Neurology Associates
- Cleveland Clinic, Cole Eye Institute
- Dean McGee Eye Institute
- University of Pennsylvania, Scheie Eye Institute
- Retina Consultants of Charleston
- University of Houston, Neuro-Ophth of Texas
- Houston Methodist Hospital, Blanton Eye Institute
- Foresight Studies
- University of Utah John A. Moran Eye Center
- University of Virginia Health Sciences Center
- Swedish Medical Center, CO/NOCNW
- University of Washington Department of Ophthalmology
- Sydney Eye Hospital/Save Sight Institute
- Vision South Australia
- The Royal Victorian Eye and Ear Hospital
- Royal Perth Hospital
- The Second Xiangya Hospital of Central South University
- Peking University Eye Center, The Third Hospital Peking University.
- Beijing Tongren Hospital, Capital Medical University
- Peking Union Medical College Hospital
- Tianjin Eye Hospital
- Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
- Universitätsklinikum Aachen-Augenklinik
- Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
- Universitätsklinikum Münster
- Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
- Universitäts-Augenklinik Tübingen
- L V Prasad Eye Institute
- L V Prasad Eye Institute
- Sri Sankaradeva Nethralaya
- Narayana Nethralaya
- PBMA'S H. V. Desai Eye Hospital
- L V Prasad Eye Institute
- Sankara Nethralaya (Vision Research Foundation)
- Aravind Eye Hospital
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
- ICARE Research Centre and Post Graduate Institute
- Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
- Datta Meghe Institute of Medical Sciences
- Hadassah Medical Center
- Soroka University Medical Center
- Bnai Zion Medical Center
- Rabin Medical Center, Belinson Campus
- Kaplan Medical Center
- The Tel-Aviv Sourasky Medical Center
- The Chaim Sheba Medical Center
- AOU Policlinico S. Orsola-Malpighi
- AOU Careggi
- Scientific Institute Auxologico Italiano
- Scientific institute San Raffaele
- University Eye Clinic
- Singapore National Eye Centre
- Tan Tock Seng Hospital, Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
single dose or multiple dose
single or multiple dose
Sham
Arm Description
QPI-1007 Injection - 1.5 mg
QPI-1007 Injection - 3.0 mg
Sham injection procedure
Outcomes
Primary Outcome Measures
Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
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
Secondary Outcome Measures
Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye
Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02341560
Brief Title
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
An interim analysis did not warrant to continue enrollment
Study Start Date
February 24, 2016 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Quark Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Arteritic Anterior Ischemic Optic Neuropathy
Keywords
NAION
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
732 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single dose or multiple dose
Arm Type
Active Comparator
Arm Description
QPI-1007 Injection - 1.5 mg
Arm Title
single or multiple dose
Arm Type
Active Comparator
Arm Description
QPI-1007 Injection - 3.0 mg
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
Sham injection procedure
Intervention Type
Drug
Intervention Name(s)
QPI-1007 Injection - 1.5 mg
Other Intervention Name(s)
QPI-1007
Intervention Type
Drug
Intervention Name(s)
QPI-1007 Injection - 3.0 mg
Other Intervention Name(s)
QPI-1007
Intervention Type
Other
Intervention Name(s)
Sham Injection Procedure
Other Intervention Name(s)
Sham
Intervention Description
Sham Procedure
Primary Outcome Measure Information:
Title
Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
Time Frame
Baseline through Month 12
Title
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
Secondary Outcome Measure Information:
Title
Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye
Time Frame
Day 1 through Month 12
Title
Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry
Time Frame
Day 1 through Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Klier, M.D.
Organizational Affiliation
Quark Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas Medical Center, Jones Eye Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Loma Linda University Eye Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
NeuroEyeOrbit Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
Unversity of California, Los Angeles (UCLA)
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of Colorado Denver, Department of Neurology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Retina Consultants of Southern Colorado, PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
The Eye Care Group
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
University of Miami Miller School of Medicine/Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sarasota Retina Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago, Department of Ophthalmology (MC 648)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
NorthShore University Healthsystem
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
University of Kentucky, Department of Neurology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Greater Baltimore Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Bethesda Neurology, LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
21118
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska Medical Center and Truhlsen Eye Institute
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Rutgers, New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
New York Eye and Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Cornell University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10583
Country
United States
Facility Name
University of Rochester, Flaum Eye Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke University Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Raleigh Neurology Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Cleveland Clinic, Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
University of Pennsylvania, Scheie Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Retina Consultants of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
University of Houston, Neuro-Ophth of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Houston Methodist Hospital, Blanton Eye Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Foresight Studies
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
University of Utah John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia Health Sciences Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Swedish Medical Center, CO/NOCNW
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Department of Ophthalmology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Sydney Eye Hospital/Save Sight Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Vision South Australia
City
Kent Town
State/Province
South Australia
ZIP/Postal Code
5267
Country
Australia
Facility Name
The Royal Victorian Eye and Ear Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Peking University Eye Center, The Third Hospital Peking University.
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Beijing Tongren Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Tianjin Eye Hospital
City
Tianjin
ZIP/Postal Code
300000
Country
China
Facility Name
Universitätsmedizin d. Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Aachen-Augenklinik
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus-Dresden-Klinik und Poliklinik für Augenheilkunde
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Regensburg-Klinik und Poliklinik für Augenheilkunde
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitäts-Augenklinik Tübingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
L V Prasad Eye Institute
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
L V Prasad Eye Institute
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530040
Country
India
Facility Name
Sri Sankaradeva Nethralaya
City
Guwahati
State/Province
Assam
ZIP/Postal Code
781028
Country
India
Facility Name
Narayana Nethralaya
City
Bangalore
State/Province
Karnataka,
ZIP/Postal Code
560010
Country
India
Facility Name
PBMA'S H. V. Desai Eye Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411060
Country
India
Facility Name
L V Prasad Eye Institute
City
Bhubaneswar
State/Province
Orissa
ZIP/Postal Code
751024
Country
India
Facility Name
Sankara Nethralaya (Vision Research Foundation)
City
Chennai
State/Province
Tami Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625020
Country
India
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226014
Country
India
Facility Name
ICARE Research Centre and Post Graduate Institute
City
Noida
State/Province
Uttar Pradesh
ZIP/Postal Code
201301
Country
India
Facility Name
Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S.
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Datta Meghe Institute of Medical Sciences
City
Wardha
ZIP/Postal Code
442005
Country
India
Facility Name
Hadassah Medical Center
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Soroka University Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rabin Medical Center, Belinson Campus
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
The Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
AOU Policlinico S. Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
AOU Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Scientific Institute Auxologico Italiano
City
Milano
Country
Italy
Facility Name
Scientific institute San Raffaele
City
Milano
Country
Italy
Facility Name
University Eye Clinic
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Singapore National Eye Centre
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Tan Tock Seng Hospital, Department of Ophthalmology
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
30194931
Citation
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.
Results Reference
derived
Learn more about this trial
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
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