Non-arteritic Ischemic Optic NeuropathyPhase 2NCT02045212
Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
A Phase 2 study testing RPh201 in people with Non-arteritic Ischemic Optic Neuropathy and Optic Nerve Injuries, run by Regenera Pharma Ltd at 1 site in Israel.
Trial summary
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries
- What is being tested?
- RPh201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Dec 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants, either men or women are ≥ 18 years of age.
- Diagnosis of ischemic optic neuropathy unilateral or bilateral:
- Traumatic Neuropathy
- Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)
- Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
- Field of view with a reduction from 10 degrees to one quarter situations functions.
- Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
- Women of child bearing potential must use adequate birth-control precautions.
Who cannot join
- Glaucoma
- Neuropathy caused by tumors.
- Neuropathy caused by infections
- Mitochondrial optic neuropathies
- Nutritional, Radiation, Toxic optic neuropathies
- Retinal diabetic complications
Show all 15Show fewer
- Hereditary optic neuropathies
- Patients with complete SCOTOMA beyond three quarters.
- Clinical evidence for presence of infection.
- Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
- Patient has a history of alcohol or drug abuse within the last two years.
- Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 60 days prior to the Screening Visit or during this study.
- Clinically significant and/or uncontrolled condition or other significant medical disease
- Clinically significant uncontrolled retinal disease (AMD)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Ophthalmology Department, Western Galilee-Nahariya Medical Center
Nahariya
About this study
Official title: A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.
- Being tested
- RPh201, Placebo
- Keywords
- Ischemic Optic Neuropathy, Traumatic Neuropathy, Non Arteritic Ischemic Neuropathy (NAION)
- Medical subject headings
- Optic Nerve Injuries, Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPh201Drug
SC injection twice a week during 13/26 weeks
PlaceboDrug
SC injection twice a week during 13/26 weeks
| Study group | Role | What they receive |
|---|---|---|
| RPh201 | Experimental | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 Receives: Drug: RPh201 |
| Placebo | Placebo comparator | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit
Best Corrected Visual Acuity (BCVA) was assessed at all the visits, with refraction as necessary. VA measurements were taken in a sitting position at a test distance of 4 meters using early treatment diabetic retinopathy study (ETDRS) charts.
Measured: 26/39 weeks
Changes in Visual Field Observed Following the Treatment
Visual field mean deviation (MD) changes from the screening at week 26 using with the HVF 24-2 FASTPAC program using the size III or Size V test stimulus
Measured: 26 weeks
Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26
TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.
Measured: 26 weeks
Secondary outcomes (1)
Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam
Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam
Measured: 26/39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-arteritic Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenera Pharma Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zvi Segal,, MD, Principal investigator, Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045212
- Sponsor's protocol ID
- RGN-ON-001
- Status last verified
- Mar 2020
- First submitted
- 21 Jan 2014
- Last updated
- 19 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 31430268
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
- ClinicalTrials.gov ID
- NCT02045212
- Acronym / sponsor ID
- RGN-ON-001
- Keywords
- Ischemic Optic Neuropathy, Traumatic Neuropathy, Non Arteritic Ischemic Neuropathy (NAION)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Regenera Pharma LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPh201 | Experimental | Drug: RPh2013/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 |
| Placebo | Placebo comparator | Drug: Placebo3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants, either men or women are ≥ 18 years of age.
- Diagnosis of ischemic optic neuropathy unilateral or bilateral:
- Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
- Field of view with a reduction from 10 degrees to one quarter situations functions.
- Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
Key exclusion criteria (15 listed)
- Glaucoma
- Neuropathy caused by tumors.
- Neuropathy caused by infections
- Mitochondrial optic neuropathies
- Nutritional, Radiation, Toxic optic neuropathies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPh201SC injection twice a week during 13/26 weeks | Drug | RPh201 |
| PlaceboSC injection twice a week during 13/26 weeks | Drug | Placebo |
Primary outcome
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit
Time frame: 26/39 weeks
Best Corrected Visual Acuity (BCVA) was assessed at all the visits, with refraction as necessary. VA measurements were taken in a sitting position at a test distance of 4 meters using early treatment diabetic retinopathy study (ETDRS) charts.
Changes in Visual Field Observed Following the Treatment
Time frame: 26 weeks
Visual field mean deviation (MD) changes from the screening at week 26 using with the HVF 24-2 FASTPAC program using the size III or Size V test stimulus
Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26
Time frame: 26 weeks
TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.
1 secondary outcome
Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam
Time frame: 26/39 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31430268Rath 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zvi Segal,, MD principal investigator
Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RPh201 in people with Non-arteritic Ischemic Optic Neuropathy and Optic Nerve Injuries, run by Regenera Pharma Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit (time frame: 26/39 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02045212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2020.