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 prior to starting the study
    • 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.

    • HOW TO ADMINISTER TREATMENT

      here

      Regenera | Subcutaneous injection training with French subtitles from Regenera Pharma on Vimeo.

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) 723-4846

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) 817-4722

 

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: (843) 763-4466

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: (843) 763-4466

 

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) 243-0314

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: (847) 657-1750

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:Alex Leite
Alex_Leite@meei.harvard.edu

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

Phone: (617) 573-5558

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) 286-2946

New York

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

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

SC: Katy Tai
ktai@nyee.edu

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

Phone: (646) 943-7925

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

1701 Sunset Blvd, Suite 6300
Houston, Texas 77005

Contact:
Laura Perez lperez@neuroeye.com
Phone: (281) 723-8593

David DeLeon ddeleon@neuroeye.com 
Phone: (713) 550-7877

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) 243-5737

  • 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 Nurit Novak, Ph.D.,    Tel.: 1 (800) 787-1762 clinical@regenerapharma.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.