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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02341560




Registration number
NCT02341560
Ethics application status
Date submitted
13/01/2015
Date registered
19/01/2015
Date last updated
16/07/2019

Titles & IDs
Public title
Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Scientific 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)
Secondary ID [1] 0 0
QRK207
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Arteritic Anterior Ischemic Optic Neuropathy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - QPI-1007 Injection - 1.5 mg
Treatment: Drugs - QPI-1007 Injection - 3.0 mg
Other interventions - Sham Injection Procedure

Active Comparator: single dose or multiple dose - QPI-1007 Injection - 1.5 mg

Active Comparator: single or multiple dose - QPI-1007 Injection - 3.0 mg

Sham Comparator: Sham - Sham injection procedure


Treatment: Drugs: QPI-1007 Injection - 1.5 mg


Treatment: Drugs: QPI-1007 Injection - 3.0 mg


Other interventions: Sham Injection Procedure
Sham Procedure

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effect of QPI-1007 as assessed by Best Corrected Visual Acuity (BCVA)
Timepoint [1] 0 0
Baseline through Month 12
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline through Month 12
Secondary outcome [1] 0 0
Mean change in BCVA score, as measured by ETDRS visual acuity protocol in the study eye
Timepoint [1] 0 0
Day 1 through Month 12
Secondary outcome [2] 0 0
Mean change of Visual Fields, as assessed by Humphrey standard automated perimetry
Timepoint [2] 0 0
Day 1 through Month 12

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Eye Hospital/Save Sight Institute - Sydney
Recruitment hospital [2] 0 0
Vision South Australia - Kent Town
Recruitment hospital [3] 0 0
The Royal Victorian Eye and Ear Hospital - Fitzroy
Recruitment hospital [4] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5267 - Kent Town
Recruitment postcode(s) [3] 0 0
3002 - Fitzroy
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Missouri
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United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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United States of America
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Utah
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United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
United States of America
State/province [24] 0 0
Washington
Country [25] 0 0
China
State/province [25] 0 0
Hunan
Country [26] 0 0
China
State/province [26] 0 0
Beijing
Country [27] 0 0
China
State/province [27] 0 0
Tianjin
Country [28] 0 0
Germany
State/province [28] 0 0
Rheinland-Pfalz
Country [29] 0 0
Germany
State/province [29] 0 0
Aachen
Country [30] 0 0
Germany
State/province [30] 0 0
Dresden
Country [31] 0 0
Germany
State/province [31] 0 0
Münster
Country [32] 0 0
Germany
State/province [32] 0 0
Regensburg
Country [33] 0 0
Germany
State/province [33] 0 0
Tubingen
Country [34] 0 0
India
State/province [34] 0 0
Andhra Pradesh
Country [35] 0 0
India
State/province [35] 0 0
Assam
Country [36] 0 0
India
State/province [36] 0 0
Karnataka,
Country [37] 0 0
India
State/province [37] 0 0
Maharashtra
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India
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Orissa
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India
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Tami Nadu
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India
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Tamil Nadu
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India
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Uttar Pradesh
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India
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New Delhi
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India
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Wardha
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Israel
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Yerushalayim
Country [45] 0 0
Israel
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Beer-Sheva
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
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Israel
State/province [47] 0 0
Petach-Tikva
Country [48] 0 0
Israel
State/province [48] 0 0
Rehovot
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Israel
State/province [49] 0 0
Tel-Aviv
Country [50] 0 0
Israel
State/province [50] 0 0
Tel-Hashomer
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Italy
State/province [51] 0 0
Bologna
Country [52] 0 0
Italy
State/province [52] 0 0
Firenze
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Italy
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Milano
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Italy
State/province [54] 0 0
Parma
Country [55] 0 0
Singapore
State/province [55] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Quark Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02341560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Klier, M.D.
Address 0 0
Quark Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02341560