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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPh201 | Experimental | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 |
|
| Placebo | Placebo Comparator | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPh201 | Drug | SC injection twice a week during 13/26 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 26/39 weeks |
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Inclusion Criteria:
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.
Women of child bearing potential must use adequate birth-control precautions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zvi Segal,, MD | Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Department, Western Galilee-Nahariya Medical Center | Nahariya | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31430268 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RPh201 | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 RPh201: SC injection twice a week during 13/26 weeks |
| FG001 | Placebo | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo Placebo: SC injection twice a week during 13/26 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RPh201 | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 RPh201: SC injection twice a week during 13/26 weeks |
| BG001 | Placebo | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo Placebo: SC injection twice a week during 13/26 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Efficacy | Posted | Mean | Standard Error | EDTRS Letters | 26/39 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RPh201 | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 RPh201: SC injection twice a week during 13/26 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Konstantin Adamsky | Regenera Pharma Ltd | +972 8 9316306 | kostia@Regenerapharma.com |
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| ID | Term |
|---|---|
| D020221 | Optic Nerve Injuries |
| D018917 | Optic Neuropathy, Ischemic |
| ID | Term |
|---|---|
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
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| Drug |
SC injection twice a week during 13/26 weeks |
|
| Finished 13 weeks, chose not to extend |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | metres |
|
| Weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg per metre squared |
|
|
|
| Secondary | 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 | Posted | Number | participants | 26/39 weeks |
|
|
|
| Primary | 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 | Efficacy | Posted | Mean | Standard Error | dB | 26 weeks |
|
|
|
| Primary | 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. | Efficacy | Posted | Mean | Standard Error | µm | 26 weeks |
|
|
|
| 4 |
| 13 |
| 13 |
| 13 |
| EG001 | Placebo | 3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo Placebo: SC injection twice a week during 13/26 weeks | 1 | 9 | 9 | 9 |
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Visual acuity decreased | Eye disorders | Systematic Assessment |
|
| Brucellosis | Infections and infestations | Systematic Assessment |
|
| Ischemic optic neuropathy - AION right eye | Eye disorders | Systematic Assessment |
|
| Abnormal sensation in eye | Eye disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Conjunctival irratation | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Corneal defect | Eye disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eye Movement Disorder | Eye disorders | Systematic Assessment |
|
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Eye swelling | Eye disorders | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | Systematic Assessment |
|
| Photopsia | Eye disorders | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Facial pain | General disorders | Systematic Assessment |
|
| Gait disturbance | General disorders | Systematic Assessment |
|
| Hypothermia | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site mass | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Injection site warmth | General disorders | Systematic Assessment |
|
| Nodule | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Retinal injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intraocular pressure (IOP) increased | Investigations | Systematic Assessment |
|
| Weight decreased | Investigations | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscles spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Upper extremity mass | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Parasthesia | Nervous system disorders | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Nipple swelling | Reproductive system and breast disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Orapharyngeal | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dermatitus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Removal of foreign body | Surgical and medical procedures | Systematic Assessment |
|
| Haematoma | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Visual acuity decreased (II) | Eye disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Injection site inflammation | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site rash | General disorders | Systematic Assessment |
|
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| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Changes Visual Field size V |
|
|