Phase 3 NAION Study:
Now Recruiting

  • NON-ARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION) TREATMENT STUDY

    NON-ARTERITIC ANTERIOR ISCHEMIC OPTIC NEUROPATHY (NAION) TREATMENT STUDY

    Non-arteritic anterior ischemic optic neuropathy (NAION) is the most common cause of optic nerve-related sudden and permanent loss of vision in older adults. Currently there is no treatment that can improve vision after an NAION attack. Regenera Pharma has begun a treatment trial in the US. The study is evaluating whether a drug made from purified plant sap is safe and if it improves vision in people who have lost vision due to NAION. A plant sap called Gum Mastic, which already is used in some medicines and food. The drug will be given by self-injection (just like insulin injections for diabetes) at enrollment and twice a week for 26 weeks. Below are some details about the study.

  • STUDY REQUIREMENTS TO PARTICIPATE:

    STUDY REQUIREMENTS TO PARTICIPATE:

    • Records must be available indicating definite diagnosis of NAION.
    • You must have been at least 50 years old when NAION occurred
    • NAION must have occurred at least 1 year and not more than 5 years earlier
    • Your vision will be thoroughly evaluated to be certain that you are eligible to join the clinical study
    • You must be able to understand and sign a form called an Informed Consent that explains the study

  • HOW MANY APPOINTMENTS WILL PARTICIPANTS HAVE IN THE STUDY?

    HOW MANY APPOINTMENTS WILL PARTICIPANTS HAVE IN THE STUDY?

    • Two or three screening visits to make sure you qualify
    • Six subsequent clinic visits (baseline, week 1, week 4, week 12, week 26 and week 52)
    • One telephone call at week 36

  • IS THERE A COST FOR PARTICIPATING IN THE STUDY?

    IS THERE A COST FOR PARTICIPATING IN THE STUDY?

    All study-related activities are at no cost.

    WILL I BE PAID TO PARTICIPATE IN THE STUDY?

    You will receive no payment for participating in the study. You will receive compensation for travel to attend study visits.

WHAT SITES ARE PARTICIPATING IN THE STUDY

California

Byers Eye Institute at Stanford University (Site 109)

PI: Yaping Joyce Liao, MD, PhD
yjliao@stanford.edu

SC: Mariana Nunez
mnunez1@stanford.edu

2452 Watson Court
Palo Alto, CA 94303

Phone: (650) 723-6995

California

Doheny Eye Center UCLA
(Site 106)

PI: Peter Quiros, MD
quiros@jsei.ucla.edu

SC: Martin Garcia
mkgarcia@mednet.ucla.edu

625 S. Fair Oaks Ave., Suite 227
Pasadena, CA 91105

Phone: (626) 817-4747

 

Connecticut

The Eye Care Group
(Site 102)

PI: Robert Lesser, MD
rlesser@theeyecaregroup.com

SC:Lisa Marcil
lmarcil@theeyecaregroup.com

250 Indian River Rd Orange, CT 06477

Phone: (203) 597-9100

Connecticut

The Eye Care Group
(Site 103)

PI: Robert Lesser. MD
rlesser@theeyecaregroup.com

SC: Lisa Marcil
lmarcil@theeyecaregroup.com

22 Old Waterbury Rd, Suite 202
Southbury, CT 06488

Phone: (203) 597-9100

 

Florida

Bascom Palmer Eye Institute
(Site 114)

PI: Byron Lam, MD
blam@med.miami.edu

SC: Isabel Jaraba
ijaraba@med.miami.edu

900 NW 17th ST., 3rd Floor
Miami, FL 33136

Phone: (305) 326-6340

Illinois

NorthShore University Health System (Site 111)

PI: John Pula, MD
jpula12009@gmail.com

SC: Mira Shiloach, MS, CCRP
mshiloach@northshore.org

2050 Pfingsten Rd., Suite 280
Glenview, IL 60026

Phone: (224) 251-2020

 

Maryland

Bethesda Neurology, LLC
(Site 105)

PI: David M Katz, MD
dmk.bethesda@gmail.com

SC: Riley Kastenhuber
drkatzctc@gmail.com

3202 Tower Oaks Blvd, Suite 330
North Bethesda, MD 20852

Phone: (301) 540-2700

 

Massachusetts

Massachusetts Eye and Ear Infirmary (Site 110)

PI: Elizabeth Fortin, MD
elizabeth_fortin@meei.harvard.edu

SC: Maria Gutierrez, MD
mariaelena_gutierrez@meei.harvard.edu

Neuro-Ophthalmology Dept. 9th Floor,
243 Charles St.
Boston, MA 02114

Phone: (617) 573-3202

Missouri

Washington University in St. Louis School of Medicine (Site 113)

PI: Gregory Van Stavern, MD
vanstaverng@vision.wustl.edu

SC: Eve Adcock
adcock@wustl.edu

4901 Forest Park Ave.
Eye Center, 6th Floor
St. Louis, MO 63108

Phone: (314) 362-3937

 

New York

New York Eye and Ear Infirmary of Mount Sinai (Site 107)

PI: Rudrani Banik, MD
rubrani.banikmd@gmail.com

SC: Katy Tai
ktai@nyee.edu

310 E 14th St. Suite 500, South Building
New York, NY 10003

Phone: (212) 979-4000

 

South Carolina

Charleston Neuroscience Institute (Site 101)

PI: Virgil Alfaro, MD
virgil.alfaro@gmail.com

SC:Monica Rodriguez
mrfontal@gmail.com

9565 Hwy 78, Building 300 Ladson, SC 29456

Phone: (843) 763-4466

Texas

Neuro-Eye Clinical Trials, Inc.
(Site 104)

PI: Jade Schiffman, MD
jschiffman@neuroeye.com

SC: Alonso Prusmack
aprusmack@neuroeye.com

1701 Sunset Blvd, Suite 6300
Houston, Texas 77005

Phone: (713) 592-6550

 

Virginia

University of Virginia
(Site 108)

PI: Steven Newman, MD
san1a@hscmail.mcc.virginia.edu

SC: Ashton Leone, MPH, CCRP
aml1q@hscmail.mcc.virginia.edu

1300 Jefferson Park Ave
Charlottesville, VA 22903
Phone: (434) 924-5978

  • TO LEARN MORE ABOUT THE STUDY

    TO LEARN MORE ABOUT THE STUDY

    Please go to http://clinicaltrials.gov for more information.

    To learn more about this study, you or your doctor may:

    • contact the study research staff using the contact information above.
    • contact Kevin P Hennegan, M.A.
      1-720-746-1190,  khennegan@cbrintl.com

    Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547206

    We welcome you to take part in this exciting research study.