Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
NCT ID: NCT03547206
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
165 participants
INTERVENTIONAL
2018-07-10
2020-09-27
Brief Summary
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Detailed Description
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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.
Cohort A 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
Cohort B After randomization, participants will begin a 12-week schedule consisting of four-times-per-week treatment. Participants will return to the clinic for visits at Week 4 and Week 12.
Safety and efficacy parameters will be recorded throughout the duration of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RPh201 Cohort A
A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the Investigational Medical Product (IMP) (20 mg RPh201).
RPh201 Cohort A
RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
Placebo Cohort A
A 26-week schedule consisting of twice-weekly subcutaneous administration of 400 μL of the vehicle control.
Placebo Cohort A
The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).
RPh201 Cohort B
A 12-week schedule consisting of four-times-per-week subcutaneous administration of 400 μL of the Investigational Medical Product (IMP) (20 mg RPh201).
RPh201 Cohort B
RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
Placebo Cohort B
A 12-week schedule consisting of four-times-per-week subcutaneous administration of 400 μL of the vehicle control.
Placebo Cohort B
The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).
Interventions
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RPh201 Cohort A
RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
Placebo Cohort A
The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).
RPh201 Cohort B
RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
Placebo Cohort B
The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The participant must understand the nature of the procedure and provide written informed consent prior to any study procedure.
3. The participant has a definitive clinical diagnosis of NAION in the study eye that developed at least 12 months before randomization. Specifically, the disc swelling must have been observed and documented (by examination, OCT or photograph) by an ophthalmologist or neuro-ophthalmologist who previously examined the participant at the time of the NAION episode in the study eye during the acute episode.
4. The participant's study eye must have disc pallor (global or segmental) present.
5. The participant's study eye must have stable visual acuity (see Sections 5.3.3 and 5.3.4).
6. Using the study eye, the participant must read at least 20 and at most 66 EVA letters with best-corrected vision, at each Screening visit.
7. The participant's study eye must have a HVF 24-2 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 (criteria in the MOP).
1. The participant must be 50 years of age or older at the time of the NAION episode in the study eye. This means that the participant's age at enrollment must be greater than or equal to the sum of 50 plus the number of years since NAION (e.g., at least 52 years of age if the episode was two years prior).
2. The participant must understand the nature of the procedure and provide written informed consent prior to any study procedure.
3. The participant has a definitive clinical diagnosis of NAION in the study eye that developed at least 6 months and no more than 3 years before randomization. Specifically, the disc swelling must have been observed and documented (by examination, OCT or photograph) by an ophthalmologist or neuro-ophthalmologist who previously examined the participant at the time of the NAION episode in the study eye during the acute episode.
4. The participant's study eye must have disc pallor (global or segmental) present.
5. The participant's study eye must have stable visual acuity (see Sections 5.3.3 and 5.3.4).
6. Using the study eye, the participant must read at least 20 and at most 66 EVA letters with best-corrected vision, at each Screening visit.
Exclusion Criteria
2. The participant had surgery, requiring general anesthesia with intubation, within 30 days prior to enrollment.
3. The participant is pregnant or a woman of child-bearing potential not using an acceptable method of contraception (per Section 4.1 of the protocol).
4. The participant is breast-feeding or plans to breast-feed.
5. 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, brimonidine) within 6 months prior to enrollment.
6. The participant has participated in another interventional clinical trial within 60 days prior to enrollment, or previously participated in another clinical trial of RPh201 at any time.
7. The participant has been receiving or has received within three months prior to enrollment, corticosteroids (except topical steroids, steroid inhalers or intermittent injections into a joint or back), or immunosuppressive drugs.
8. The participant has a medical condition, social or psychological issue, or other condition which, in the judgment of the investigator, could be a safety concern or preclude the individual from completing the protocol.
9. The participant has a known allergy to cottonseed oil.
10. The participant is planning to move and not relocate near a study site and is unwilling to travel for appointments.
11. The participant cannot self-administer or arrange for administration of the IP.
12. The participant has one or more of the following abnormal test results at screening:
* Erythrocyte Sedimentation Rate (ESR) above age/2 for men or \[age + 10\]/2 for women, as measured by Westergren method or equivalent.
* Platelets \>400,000 mm3
* C-reactive protein (CRP) greater than two times the laboratory upper limit of normal.
* Severe anemia (Hgb \< 10)
13. The participant has symptoms, signs, and/or diagnosis of giant cell arteritis at any time.
14. The participant has any other optic neuropathies (e.g., optic neuritis or glaucoma) in either or both eyes (other than self-limited optic neuropathies in the non-study eye, such as past traumatic optic neuropathy or past transient steroid-induced glaucoma due to localized steroid administration).
15. The participant has systemic inflammatory or infectious disease associated with optic neuropathy or ocular disease.
16. The participant has a history of uveitis in the study eye within the last 10 years.
17. 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.
18. The participant has a visual field defect with homonymous non-altitudinal features or a defect that respects the vertical meridian.
1. The participant has received treatment for cancer within 12 months prior to enrollment (excluding localized basal cell carcinoma or localized squamous cell carcinoma) or had past diagnosis of cancer adjacent to the afferent visual pathway or had past diagnosis of metastatic cancer.
2. The participant had surgery, requiring general anesthesia with intubation, within 30 days prior to enrollment.
3. The participant is pregnant or a woman of child-bearing potential not using an acceptable method of contraception (per Section 4.1 of the protocol).
4. The participant is breast-feeding or plans to breast-feed.
5. 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, brimonidine) within 6 months prior to enrollment.
6. The participant has participated in another interventional clinical trial within 60 days prior to enrollment, or previously participated in another clinical trial of RPh201 at any time. Participants who were randomized into the placebo arm of Cohort A of this protocol are eligible for screening for Cohort B.
7. The participant has been receiving or has received within three months prior to enrollment, corticosteroids (except topical steroids, steroid inhalers or intermittent injections into a joint or back), or immunosuppressive drugs.
8. The participant has a medical condition, social or psychological issue, or other condition which, in the judgment of the investigator, could be a safety concern or preclude the individual from completing the protocol.
9. The participant has a known allergy to cottonseed oil.
10. The participant is planning to move and not relocate near a study site and is unwilling to travel for appointments.
11. The participant cannot self-administer or arrange for administration of the IP.
12. The participant has one or more of the following abnormal test results at screening:
1. Erythrocyte Sedimentation Rate (ESR) above age/2 for men or \[age + 10\]/2 for women, as measured by Westergren method or equivalent.
2. Platelets \>400,000 mm3
3. C-reactive protein (CRP) greater than two times the laboratory upper limit of normal.
4. Severe anemia (Hgb \< 10 g/dL)
13. The participant has symptoms, signs, and/or diagnosis of giant cell arteritis at any time.
14. The participant has any other optic neuropathies (e.g., optic neuritis or glaucoma) in either or both eyes (other than self-limited optic neuropathies in the non-study eye, such as past traumatic optic neuropathy or past transient steroid-induced glaucoma due to localized steroid administration).
15. The participant has systemic inflammatory or infectious disease associated with optic neuropathy or ocular disease.
16. The participant has a history of uveitis in the study eye within the last 10 years.
17. 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.
18. The participant has a visual field defect with homonymous non-altitudinal features or a defect that respects the vertical meridian.
50 Years
ALL
No
Sponsors
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Regenera Pharma Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Leonard A Levin, M.D., Ph.D.
Role: STUDY_CHAIR
McGill University
Locations
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Byers Eye Institute at Stanford University
Palo Alto, California, United States
UCLA Doheny Eye Center
Pasadena, California, United States
The Eye Care Group
Orange, Connecticut, United States
The Eye Care Group
Waterbury, Connecticut, United States
Anne Bates Leach Eye Hospital/Bascom Palmer Eye Institute
Miami, Florida, United States
Emory University
Atlanta, Georgia, United States
NorthShore Medical Group
Glenview, Illinois, United States
Bethesda Neurology, LLC
Rockville, Maryland, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
Washington University Ophthalmology
St Louis, Missouri, United States
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Neuro-Eye Clinical Trials, Inc.
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Rath EZ, Hazan Z, Adamsky K, Solomon A, Segal ZI, Levin LA. Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2019 Sep;39(3):291-298. doi: 10.1097/WNO.0000000000000786.
Related Links
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Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy
Other Identifiers
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RGN-ON-002
Identifier Type: -
Identifier Source: org_study_id
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