CompletedPhase 2

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)

United States, Singapore, Vietnam46 participantsStarted 2013-12

Plain-language summary

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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of a single intravitreal (IVT) dose of QPI-1007 as assessed by adverse events (AE)

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Timeframe: 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)

Timeframe: Days 0 and 7, and Month 1 to 6

Trial details

NCT IDNCT01965106

SponsorQuark Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-06

View on ClinicalTrials.gov More Glaucoma, Angle-closure, Primary, Acute trials