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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Quark Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01965106
First received: September 11, 2013
Last updated: September 9, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Glaucoma, Angle-closure, Primary, Acute
Drug: QPI-1007 Injection
Drug: (including placebo)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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)

Resource links provided by NLM:


Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between QPI-1007 and control group (sham) as assessed by the prevalence of the abnormal visual fields [ Time Frame: 4 months after injection ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Difference between QPI-1007 and control group (sham) as assessed by SD-OCT parameters [ Time Frame: 4 months after injection ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QPI-1007 Injection
single intravitreal (IVT) injection of QPI-1007
Drug: QPI-1007 Injection
1.5 mg QPI-1007 Injection
Sham Comparator: Control
Placebo (Sham injection procedure)
Drug: (including placebo)
Sham injection procedure

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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965106

Contacts
Contact: Judith Lynn jlynn@quarkpharma.com

Locations
United States, California
The Gavin Herbert Eye Institute, UC Irvine Recruiting
Orange, California, United States, 92868
Contact: Jeff Grijalva    714-456-7741    jgrijalv@uci.edu   
Principal Investigator: Sameh Mosaed, MD         
United States, Texas
Robert Cizik Eye Clinic - Clinical Trials Unit Recruiting
Houston, Texas, United States, 77030
Contact: Laura Baker    713-795-0768    laurabaker@cizikeye.org   
Principal Investigator: Robert Feldman, MD         
United States, Washington
Dept. of Ophthalmology, University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Sue Rath    206-897-4331    raths@u.washington.edu   
Principal Investigator: Raghu Mudumbai, MD         
Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore, 168751
Contact: Stella Ng    +65-6322-4598      
Principal Investigator: Tin Aung, Prof. MD         
Vietnam
Vietnam National Institute of Ophthalmology Recruiting
Ha Noi, Vietnam
Contact: Hai Lam Vu    +84-983-661-476      
Principal Investigator: Nhu Hon Do, MD         
Hanoi Eye Hospital Recruiting
Ha Noi, Vietnam
Contact: Thi Hong Duong Pham    +84-987-827-644      
Principal Investigator: Thi Thanh Vu, MD         
Ho Chi Minh City Eye Hospital Recruiting
Ho Chi Minh City, Vietnam
Contact: Nguyen Huan Pham    +84-908-221-475      
Principal Investigator: Anh Tuan Tran, MD         
Sponsors and Collaborators
Quark Pharmaceuticals
Investigators
Study Chair: Avner Ingerman, M.D., MSc. Quark Pharmaceuticals
  More Information

No publications provided

Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01965106     History of Changes
Other Study ID Numbers: QRK208
Study First Received: September 11, 2013
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration
Vietnam: Ministry of Health
Singapore: Health Sciences Authority

Keywords provided by Quark Pharmaceuticals:
Glaucoma, Angle-Closure
Glaucoma, Closed-Angle
Primary angle closure
Acute angle closure
Acute angle-closure glaucoma

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Angle-Closure
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on September 14, 2014