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Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

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ClinicalTrials.gov Identifier: NCT03547206
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Regenera Pharma Ltd

Brief Summary:
This study is designed as a double-masked, randomized, placebo-controlled, pivotal, clinical study to evaluate the efficacy and safety of subcutaneous (SC) administration of RPh201 in participants with previous NAION. All participants enrolled in the study will have a documented history of NAION for at least 12 months and at most, five years prior to enrollment.

Condition or disease Intervention/treatment Phase
Nonarteritic Anterior Ischemic Optic Neuropathy Drug: RPh201 Other: Placebo Phase 3

Detailed Description:

This study is designed as a double-masked, randomized, placebo-controlled, pivotal clinical study to evaluate the efficacy and safety of SC administration of RPh201 in participants with previous NAION.

Following a screening phase of 1-8 weeks, participants will attend a baseline visit in which they will undergo testing and visual function assessments. Participants then will be randomized to receive RPh201 or control.

After randomization, participants will begin a 26-week schedule consisting of twice-weekly treatment. Participants will return to the clinic for visits at Week 1, Week 4, Week 12 and Week 26 and Week 52

Safety and efficacy parameters will be recorded throughout the duration of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: All clinic staff and participants will be masked to group assignments. Only the Data and Safety Monitoring Board (DSMB) and designated unmasked staff at the Coordinating Center will have access to the group assignments.
Primary Purpose: Treatment
Official Title: A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: RPh201
A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the Investigational Medical Product (IMP) (20 mg RPh201).
Drug: RPh201
RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).

Placebo Comparator: Placebo
A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the vehicle control.
Other: Placebo
The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene [BHT]).
Other Name: Cottonseed oil




Primary Outcome Measures :
  1. Proportion of study eyes improving by a 15-letter score or more in best-corrected visual acuity (BCVA) from baseline measured using electronic visual acuity (EVA) [ Time Frame: Week 26 ]

Secondary Outcome Measures :
  1. The proportion of study eyes improving by a 10-letter score or more in BCVA from baseline using EVA. [ Time Frame: Week 26 ]
  2. The proportion of study eyes improving from baseline in five or more locations of the Humphrey visual field (HVF) 24-2 full-threshold with the size V stimulus on the glaucoma change probability map (GCPM) at the 5% level by group. [ Time Frame: Week 26 ]

Other Outcome Measures:
  1. The mean change from baseline in the number of BCVA letters by group. [ Time Frame: Week 26 ]
  2. The mean change in sensitivity from baseline on HVF 24-2 full-threshold with the size V stimulus. [ Time Frame: Week 26 ]
  3. The mean change from baseline in the number of BCVA letters by group. [ Time Frame: Week 52 ]
  4. The proportion of study eyes improving by a 10-letter score or more in BCVA from baseline using EVA. [ Time Frame: Week 52 ]
  5. The proportion of study eyes improving by a 15-letter score or more from baseline in BCVA by group. [ Time Frame: Week 52 ]
  6. The mean change in sensitivity from baseline on HVF 24-2 full-threshold with the size V stimulus. [ Time Frame: Week 52 ]
  7. The proportion of study eyes improving in five or more locations from baseline of the HVF 24-2 full-threshold with the size V stimulus by GCPM at the 5% level by group. [ Time Frame: Week 52 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The participant must be 50 years of age or older at the time of the NAION episode in the study eye.
  • The participant has a definitive clinical diagnosis of NAION in the study eye that developed at least 12 months and no more than five years before enrollment.
  • The participant's study eye must have stable visual acuity.
  • Using the study eye, the participant must read at least 20 and at most 60 EVA letters (i.e., Snellen equivalent of 20/400 to 20/63) with best-corrected vision.
  • The participant's study eye must have a HVF 24-2 Swedish Interactive Testing Algorithm (SITA) Standard visual field using spot size III with mean deviation -5 dB or worse and with a visual field defect compatible with NAION in the study eye.

Exclusion Criteria:

  • The participant has had treatment with drugs that have potential neuroprotective or toxic effects on the optic nerve or retina (e.g., ethambutol, amiodarone, linezolid, hydroxychloroquine, fingolimod) within 6 months prior to enrollment.
  • The participant has been receiving or has received within three months prior to enrollment, corticosteroids (except steroid inhalers or intermittent injections into a joint or back), immunosuppressive drugs, cytotoxic agents, radiation therapy or chemotherapy.
  • The participant has a known allergy to cottonseed oil.
  • The participant has presence of other optic neuropathies (e.g., optic neuritis or glaucoma) in either or both eyes.
  • The participant has systemic inflammatory or infectious disease associated with optic neuropathy or ocular disease.
  • The participant has a history of uveitis in the study eye within the last 10 years.
  • The participant's study eye has an ocular condition that appears consistent with a reduction in visual acuity to <20/25, diabetic retinopathy beyond mild non-proliferative diabetic retinopathy not involving the macula, or vision-threatening macula disease.
  • The participant has a visual field defect with homonymous non-altitudinal features or a defect that respects the vertical meridian.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Contacts
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Contact: Kevin P Hennegan, M.A. 1-720-746-1190 khennegan@cbrintl.com

Locations
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United States, California
UCLA Doheny Eye Center Recruiting
Pasadena, California, United States, 91105
Contact: Martin Garcia    626-817-4747    MKGarcia@mednet.ucla.edu   
Principal Investigator: Peter Quiros, M.D.         
United States, Connecticut
The Eye Care Group Recruiting
Orange, Connecticut, United States, 06477
Contact: Sue Heaton    203-573-4897    sheaton@theeyecaregroup.com   
Principal Investigator: Robert L Lesser, MD         
The Eye Care Group Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Sue Heaton    203-573-4897    sheaton@theeyecaregroup.com   
Principal Investigator: Robert L Lesser, MD         
United States, Florida
Anne Bates Leach Eye Hospital/Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Isabel Jaraba    305-243-0314    ijaraba@med.miami.edu   
Principal Investigator: Byron L Lam, M.D.         
United States, Illinois
NorthShore Medical Group Recruiting
Glenview, Illinois, United States, 60026
Contact: Mira Shiloach, MS, CCRP    847-657-1750    mshiloach@northshore.org   
Principal Investigator: John H Pula, MD         
United States, Maryland
Bethesda Neurology, LLC Recruiting
Rockville, Maryland, United States, 20852
Contact: Riley Kastenhuber    301-540-2700    drkatzctc@gmail.com   
Principal Investigator: David Katz, MD         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Maria Gutierrez    617-391-5950      
Principal Investigator: Elizabeth Fortin, M.D.         
United States, Missouri
Washington University Ophthalmology Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Eve Adcock    314-286-2946    adcockl@wustl.edu   
Principal Investigator: Gregory Van Stavern, MD         
United States, South Carolina
Charleston Neuroscience Institute Recruiting
Ladson, South Carolina, United States, 29456
Contact: Monica Rodriguez    843-763-4466      
Principal Investigator: Virgil Alfaro, III, M.D.         
United States, Texas
Neuro-Eye Clinical Trials, Inc. Recruiting
Houston, Texas, United States, 77005
Contact: Francisco Sanchez       fsanchez@neuroeye.com   
Contact: Alonso Prusmack       aprusmack@neuroeye.com   
Principal Investigator: Jade Schiffmann, MD, FAAO, FAAN         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Ashton Leone    434-243-5737    AML7Q@hscmail.mcc.virginia.edu   
Principal Investigator: Steven A Newman, M.D.         
Sponsors and Collaborators
Regenera Pharma Ltd
Investigators
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Study Chair: Leonard A Levin, M.D., Ph.D. McGill University

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Responsible Party: Regenera Pharma Ltd
ClinicalTrials.gov Identifier: NCT03547206     History of Changes
Other Study ID Numbers: RGN-ON-002
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Regenera Pharma Ltd:
NAION
ischemic optic neuropathy

Additional relevant MeSH terms:
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Ischemia
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases