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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02341560
Ethics application status
Date submitted
13/01/2015
Date registered
19/01/2015
Date last updated
20/07/2020

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
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


Other interventions: Sham Injection Procedure
Sham Procedure
Intervention code [1] 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
Sex
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2019
Sample size
Target
Accrual to date
Final
732
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
Country [13] 0 0
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
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
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
Country [38] 0 0
India
State/province [38] 0 0
Orissa
Country [39] 0 0
India
State/province [39] 0 0
Tami Nadu
Country [40] 0 0
India
State/province [40] 0 0
Tamil Nadu
Country [41] 0 0
India
State/province [41] 0 0
Uttar Pradesh
Country [42] 0 0
India
State/province [42] 0 0
New Delhi
Country [43] 0 0
India
State/province [43] 0 0
Wardha
Country [44] 0 0
Israel
State/province [44] 0 0
Yerushalayim
Country [45] 0 0
Israel
State/province [45] 0 0
Beer-Sheva
Country [46] 0 0
Israel
State/province [46] 0 0
Haifa
Country [47] 0 0
Israel
State/province [47] 0 0
Petach-Tikva
Country [48] 0 0
Israel
State/province [48] 0 0
Rehovot
Country [49] 0 0
Israel
State/province [49] 0 0
Tel-Aviv
Country [50] 0 0
Israel
State/province [50] 0 0
Tel-Hashomer
Country [51] 0 0
Italy
State/province [51] 0 0
Bologna
Country [52] 0 0
Italy
State/province [52] 0 0
Firenze
Country [53] 0 0
Italy
State/province [53] 0 0
Milano
Country [54] 0 0
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/study/NCT02341560
Trial related presentations / publications
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.
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/study/NCT02341560