FIND a DOCTOR for NAION

NAION Clinical Trial FAQs

  1. What is NAION?
  2. What is the NAION Clinical Trial?
  3. What are the Basic Criteria to Join the Trial?
  4. How Does the Drug Work?
  5. What Does the Treatment Involve?
  6. Why Is It Important to Join the TRIAL Within 14 Days of Vision Loss?
  7. What Stage is the Clinical Trial In?
  8. Is the Trial Safe?
  9. How Can I Schedule an Appointment?
  10. Where is the Study Being Conducted?
  11. What are the Costs Associated with Participating in the Trial?
  12. Where Can I Find Published Information on This Trial?
  13. What if I Have Additional Questions?

1. What is NAION?

Non-arteritic anterior ischemic optic neuropathy (NAION) is the sudden, acute, painless vision loss in one eye. It is the most common cause of acute optic nerve injury in individuals 50 years or older. For more information on NAION, visit our "What is NAION?" page.

2. What is the NAION Clinical Trial?

NORDIC and Quark pharmaceuticals have partnered to design and conduct a trial to test a new drug specifically to treat NAION. This is an investigational drug trial to evaluate a neuroprotection therapy for acute NAION that could protect the optic nerve from further damage due to factors related to acute ischemic injury. The title of the study is “Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION).” QPI-1007 is the name of the investigational study drug.

The study is open and any patient, who appears to have the disorder and meets the entry criteria listed below can be screened by a study site. All study related screening, tests, and procedures are paid for by the study sponsor, Quark Pharmaceuticals, Inc.

You can view both the clinicaltrials.gov webpage and the sponsor webpage for more information on this study.

3. What are the Basic Criteria to Join the Trial?

When you see a doctor to be evaluated for the study, you will have several screening examinations to determine your eligibility, including checking your vision and your visual field, looking inside your eye and taking some images of your eye. However, the basic criteria are below. If you have not yet seen a doctor to determine if your optic nerve is swollen, you may still be considered.

  1. Age 50-80 years old
  2. Sudden vision loss in one eye within the last 14 days
  3. Have been told by your doctor the affected nerve is swollen

4. What Does the Treatment Involve?

The investigational treatment (or “study drug”) in this trial is an intravitreal injection, which is an injection into the vitreous, which is the jelly-like substance inside the eye. It is performed to place medicine inside the eye. Intravitreal injections are commonly and safely used to treat macula degeneration, diabetic retina disease, and retina vein occlusion.

Research subjects will be randomized to either receive an injection of the experimental study drug or randomized to the placebo. Subjects have a 1 in 5 chance of being randomized to the placebo. Study visits are slightly more frequent than standard of care, and will occur more frequently at the beginning of the trial. The study involves 8 visits over 12 months.

5. How Does the Drug Work?

The experimental study drug is believed to protect the optic nerve from further damage due to factors related to acute ischemic injury. The study drug is designed to temporarily block the cells of the body from making a protein called “caspase 2”. High levels of caspase 2 have been found when cells are damaged due to lack of oxygen. In NAION, nerve cells become damaged because of lack of oxygen. Temporarily stopping the nerve cells in the eye from making caspase 2 after they are damaged could give the cells more time to make repairs which may prevent further loss of vision and possibly improve vision.

6. Why Is It Important to Join the Trial Within 14 Days of Vision Loss?

The damage to the optic nerve caused by NAION can continue and cause worsening vision loss as time goes on after the initial “attack,” or acute ischemic injury. In order to best test the efficacy of the experimental study drug, this clinical trial was designed to evaluate the effect of near immediate treatment (within 14 days of vision loss) to stop or reverse this continued vision loss. Patients are only able to receive the study drug within the first 14 days after initial vision loss. If it has been longer than 14 days since you first experienced vision loss, you will not be eligible to receive the study drug; however, you should still seek evaluation by an eye doctor as soon as possible.

7. What Stage is the Clinical Trial In?

This trial is a phase 2/3. Clinical trials are described in phases one through five, however phases two and three can sometimes be combined into one study. For this trial, this means that the experimental treatment has already been evaluated for safety and deemed safe for further evaluation. The phase 2/3 study includes testing the study drug on a larger group of people and evaluating the efficacy of the drug (does it work? And how well?).

For more information on the phases of clinical trials, you can go to ClinicalTrials.gov - Clinical Trial Phases.

8. Is the Trial Safe?

The Phase 1 evaluation of this experimental study drug was completed, and the results can be found on the clinicaltrials.gov page. The study drug was found to be safe for further evaluation of how well it works.

9. How Can I Schedule an Appointment?

You should use the Find a Doctor for NAION page to help find the nearest doctor to you that is participating in the trial. You will find the contact information for the participating doctors on this page. For help navigating this page to find a doctor, you can also contact NORDIC by calling 212-636-3516 or emailing info@NORDICclinicaltrials.com.

10. Where is the Study Being Conducted?

There will be approximately 42 sites in the United States, 7 in India, 6 in Israel, and approximately 6 in both Australia and Germany. You can go to our Find a Doctor for NAION for specific locations and contact information.

11. What are the Costs Associated with Participating in the Trial?

All study related screening, tests, and procedures are paid for by the study sponsor, Quark Pharmaceuticals. If you see one of these doctors and they determine that you do not meet the criteria for this trial, the doctor will still provide you with the best care for your vision loss.

12. Where Can I Find Published Information on This Trial?

A Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial: An Industry and NORDIC Collaboration

13. What if I Have Additional Questions?

For questions regarding this webpage or help finding a study doctor please call 212-636-3516 or email info@NORDICclinicaltrials.com.