Glaucoma, Angle-closure, Primary, AcutePhase 2NCT01965106

Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)

A Phase 2 study testing QPI-1007 Injection in people with Glaucoma, Angle-closure, Primary, Acute, run by Quark Pharmaceuticals at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Glaucoma, Angle-closure, Primary, Acute
What is being tested?: QPI-1007 Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 8 sitesin 3 countries
Study dates: Dec 2013to Jul 2015
Phase: Phase 2
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females aged at least 40 years or older.
Onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration.
Best-corrected visual acuity (BCVA) 20/40 or better in the study eye after resolution of the acute attack.
Received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye <25mm Hg.
Sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye.
Female subjects must be: (1) post menopausal, (2) surgically sterile, or (3) using an effective means of contraception.

Who cannot join

Previously diagnosed with glaucoma in either eye.
The time planned for study drug administration is more than 120 hours from the onset of the symptoms.
History of chronic angle-closure in either eye.
Secondary angle-closure/secondary angle-closure glaucoma in the study eye.
Monocular subjects.
Prior incisional intraocular surgery.

Show all 13Show fewer

Inability to perform a reliable visual field test on Day 0 in the study eye.
History of panretinal photocoagulation or macular laser photocoagulation in the study eye.
History of active malignancy within the last 5 years (however, non facial, basal cell carcinoma is allowed).
History of myocardial infarction within the last 6 months.
Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
Women who are pregnant or lactating.
Participating in a concurrent interventional study with the last intervention occurring within 30 days prior to planned dosing with QPI-1007.

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

United States4 sites

Robert Cizik Eye Clinic - Clinical Trials Unit
Houston, Texas, 77030
The Gavin Herbert Eye Institute, UC Irvine
Orange, California, 92868
Doheny Eye Center, UCLA
Pasadena, California, 91105
Dept. of Ophthalmology, University of Washington Medical Center
Seattle, Washington, 98104

Other trials in United States

Vietnam3 sites

Hanoi Eye Hospital
Hà Nội
Vietnam National Institute of Ophthalmology
Hà Nội
Ho Chi Minh City Eye Hospital
Ho Chi Minh City

Other trials in Vietnam

Singapore1 site

Singapore National Eye Centre
Singapore, 168751

Other trials in Singapore

About this study

This study will assess any side effects that may occur when QPI-1007 is injected into the eye in subjects with acute primary angle-closure glaucoma, as well as how long it takes for the body to clear the drug. This study will also test whether QPI-1007, injected into the eye, helps prevent both structural damage of the nerve tissue in the eye and the loss of visual function in subjects with acute primary angle-closure glaucoma.

Read the detailed description

This is a Phase IIa double-masked, single dose, randomized, sham-controlled study evaluating the safety and tolerability, and pharmacokinetics of QPI-1007 versus Control (sham procedure) in subjects with an acute attack of primary angle-closure glaucoma.

Subjects will be randomized at a ratio of 1:1 into one of two study arms: 1.5 QPI-1007 arm or Control arm (sham procedure). The study will enroll approximately 30 subjects into each arm. Randomization will be stratified by time from symptom onset to the study drug administration or sham procedure (≤72 hours and >72 hours).

Conditions: Glaucoma, Angle-closure, Primary, Acute
Being tested: QPI-1007 Injection, (including placebo)
Keywords: Glaucoma, Angle-Closure, Glaucoma, Closed-Angle, Primary angle closure, Acute angle closure, Acute angle-closure glaucoma
Medical subject headings: Glaucoma, Glaucoma, Angle-Closure

What participants receive

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

QPI-1007 InjectionDrug
1.5 mg QPI-1007 Injection
(including placebo)Drug
Sham injection procedure

Study groups in NCT01965106
Study group	Role	What they receive
QPI-1007 Injection	Active comparator	single intravitreal (IVT) injection of QPI-1007 Receives: Drug: QPI-1007 Injection
Control	Sham comparator	Placebo (Sham injection procedure) Receives: Drug: (including placebo)

What is being measured

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

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)
Measured: Day 0 (after injection) through Month 4. Systemic serious AEs (SAEs) assessed as related to study drug and all ocular SAEs Month 4 to Month 6 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by laboratory evaluations
Measured: Screening, Day 1, and Month 4 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by vital signs and weight
Measured: Weight: Screening and Month 4; Vital signs: Screening, Days 0 (before injection), 1 and 7, and Month 4 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (EDTRS) chart and slit lamp exams (anterior & posterior segment)
Measured: Screening, Days 0, 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Visual Field (VF) and Spectral Domain Optical Coherence Tomography (SD-OCT)
Measured: Days 0 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)
Measured: Screening, Days 0 (before injection, both eyes; after injection study eye only), 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation, Fundus Photographs (FP)
Measured: Days 0 and 7, and Month 4
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity
Measured: Days 0 and 7, and Month 4 and 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by use of concomitant treatments
Measured: Days 0, 1 and 7, and Month 1 to 6

Secondary outcomes (8)

QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax)
Measured: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
QPI-1007 pharmacokinetics (PK) parameters as assessed by the time to peak plasma concentration (Tmax)
Measured: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields
Measured: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline
Measured: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline
Measured: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean BCVA using the EDTRS chart compared to baseline
Measured: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters
Measured: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline
Measured: 4 months after injection

Timeline

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

Dec 2013Jul 2015

First posted18 Oct 2013 (estimated)
Study startDec 2013
Primary completionJun 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Glaucoma, Angle-closure, Primary, AcuteStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01965106
Sponsor's protocol ID: QRK208
Status last verified: Apr 2017
First submitted: 11 Sep 2013
Last updated: 7 Apr 2017
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIA Double-Masked Randomized Sham-Controlled Trial of QPI-1007 Delivered by a Single Intravitreal Injection to Subjects With Acute Primary Angle-Closure Glaucoma (APACG)
ClinicalTrials.gov ID: NCT01965106
Acronym / sponsor ID: QRK208
Conditions: Glaucoma, Angle-closure, Primary, Acute
Keywords: Glaucoma, Angle-Closure, Glaucoma, Closed-Angle, Primary angle closure, Acute angle closure, Acute angle-closure glaucoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Quark PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2013
Primary completion: Jun 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 18 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
QPI-1007 Injection	Active comparator	Drug: QPI-1007 Injectionsingle intravitreal (IVT) injection of QPI-1007
Control	Sham comparator	Drug: (including placebo)Placebo (Sham injection procedure)

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Males and females aged at least 40 years or older.
Onset of symptoms of an acute attack of primary angle-closure in the study eye within the 120 hours prior to the planned study drug administration.
Best-corrected visual acuity (BCVA) 20/40 or better in the study eye after resolution of the acute attack.
Received successful treatment for the acute attack of angle-closure, and have undergone laser iridotomy with intraocular pressure in the study eye <25mm Hg.
Sufficiently clear ocular media and adequate pupil dilation to allow the optic nerve and fovea to be visualized and assessed in the study eye.

Key exclusion criteria (13 listed)

Previously diagnosed with glaucoma in either eye.
The time planned for study drug administration is more than 120 hours from the onset of the symptoms.
History of chronic angle-closure in either eye.
Secondary angle-closure/secondary angle-closure glaucoma in the study eye.
Monocular subjects.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QPI-1007 Injection1.5 mg QPI-1007 Injection	Drug	QPI-1007 Injection
(including placebo)Sham injection procedure	Drug	Control

Primary outcome

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)
Time frame: Day 0 (after injection) through Month 4. Systemic serious AEs (SAEs) assessed as related to study drug and all ocular SAEs Month 4 to Month 6 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by laboratory evaluations
Time frame: Screening, Day 1, and Month 4 after injection
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by vital signs and weight
Time frame: Weight: Screening and Month 4; Vital signs: Screening, Days 0 (before injection), 1 and 7, and Month 4 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Best Corrected Visual Acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (EDTRS) chart and slit lamp exams (anterior & posterior segment)
Time frame: Screening, Days 0, 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations, Visual Field (VF) and Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Days 0 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation intraocular pressure (IOP)
Time frame: Screening, Days 0 (before injection, both eyes; after injection study eye only), 1 and 7, and Month 1 to 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluation, Fundus Photographs (FP)
Time frame: Days 0 and 7, and Month 4
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by ophthalmic evaluations optic nerve head stereo photographs and contrast sensitivity
Time frame: Days 0 and 7, and Month 4 and 6
Safety and tolerability of a single IVT dose of QPI-1007 as assessed by use of concomitant treatments
Time frame: Days 0, 1 and 7, and Month 1 to 6

8 secondary outcomes

QPI-1007 pharmacokinetics (PK) parameters as assessed by the peak plasma concentration (Cmax)
Time frame: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
QPI-1007 pharmacokinetics (PK) parameters as assessed by the time to peak plasma concentration (Tmax)
Time frame: Pre-injection, 1, 4 and 24 hours after injection, and 7 days after injection
Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields
Time frame: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean deviation compared to baseline
Time frame: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by progression of the visual fields compared to baseline
Time frame: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean BCVA using the EDTRS chart compared to baseline
Time frame: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters
Time frame: 4 months after injection
Difference between QPI-1007 and control group (sham) as assessed by change in the mean contrast sensitivity compared to baseline
Time frame: 4 months after injection

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Avner Ingerman, M.D., MSc. study chair

Quark Pharmaceuticals

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QPI-1007 Injection in people with Glaucoma, Angle-closure, Primary, Acute, run by Quark Pharmaceuticals at 8 sites in 3 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Vietnam, Singapore. 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE) (time frame: Day 0 (after injection) through Month 4. Systemic serious AEs (SAEs) assessed as related to study drug and all ocular SAEs Month 4 to Month 6 after injection). The study lists 9 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 NCT01965106.

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 7 Apr 2017.