A Phase I Clinical Trial of DARC

Inclusion Criteria All patients * ≥ 18 years * Clear optical media in the studied eye * No ocular or systemic disease (except glaucoma in the test group) * Refractive error not higher than spherical equivalent of 6D; best corrected visual acuity ≥ 6/24 at qualification * Proven ability to perform reliable visual field testing (HFA 640, central 24-2 program) to yield full thresholds, and have had good fundoscopy with assessment of the optic disc * Willing and able to comply with the scheduled visits and assessments. Informed Consent Form personally (or by legal representative) signed and dated * Women Not of Childbearing Potential (postmenopausal or permanently sterilised) * Male participants agree to double barrier contraception from consent until 6 weeks after treatment discontinuation GLAUCOMA patients • Show progression in any measured parameter; have at least one eye with a diagnosis of glaucoma (abnormal optic disc, visual field defect or both); be diagnosed as a glaucoma suspect or ocular hypertensive (elevated Intraocular Pressure (IOP)) NORMAL subjects * No evidence of any glaucomatous process (either optic disc, Retinal Nerve Fibre Layer (RNFL) of visual field abnormalities with normal IOPs) * Must provide a GP letter confirming their medical history GLAUCOMA \& NORMAL patients • Have performed at least 3 Visual Field tests, Heidelberg Retinal Tomography (HRT), and Optical Coherence Tomography (OCT) before or during Visit-1 POSITIVE CONTROL patients * Diagnosis of acute unilateral NAION in the first eye within 15 days of onset of symptoms * Snellen test (or equivalent) Visual acuity below 6/12 in the affected eye * Visual field defect and relative afferent pupillary defect (RAPD) * Normal motility of the pupillary sphincter muscle * Normal macula * Completion of 1 Visual field test, OCT and HRT examination at Visit-1 Exclusion criteria All patients * Terminal or mental illness, dementia, inability to comply with the study or follow-up procedures * Presence of ocular or systemic uncontrolled disease (unless deemed not clinically significant by Chief Investigator and Sponsor), except glaucoma in the test group * Central corneal thickness \<450µm or \>650µm * History of current or severe, unstable or uncontrolled systemic disease (unless deemed not clinically significant by Chief Investigator and Sponsor) * Body weight \<40kg or \>120kg * Evidence of another chronic neurodegenerative condition * Patients with active antiphospholipid syndrome or with diagnosis of circulating antiphospholipid antibodies * History of clotting diseases (including Deep Vein Thromboses), subjects taking anticoagulants * Diagnosis of thrombocytopenia, heart valve disease, and livedo reticularis * Pregnancy or lactation * Allergy to any study medication ingredient * Inclusion in a clinical trial of an IMP within 12 weeks prior to study entry * Ocular surgery within the past 3 months in the study eye * History of retinal laser photocoagulation * Media opacities or retinal pathology or amblyopia significantly limiting visual acuity, visual field test or retinal imaging * Expected need for ocular surgery during the study * Severe or acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the Chief Investigator, makes the subject inappropriate for the study GLAUCOMA patients * Uncontrolled IOP \>24 mmHg * Angle closure/narrow glaucoma * Mean deviation at Humphrey Visual Field (HVF) \>12dB * Unilateral glaucoma * Secondary glaucoma NORMAL subjects * History of systemic vasculitis, collagenosis or ongoing treatment of cancer * Active uveitis * Evidence of previous retinal vascular disease NORMAL \& POSITIVE CONTROL subjects • History or evidence of glaucoma (fundoscopy and Visual Field) or clinical suspicion of glaucoma on presentation or IOP ≥ 24 mmHg in either eye at any time POSITIVE CONTROL patients * Any other aetiology to explain optic nerve disease * Evidence of giant cell arteritis (history, sedimentation rate) * Evidence for other optic neuropathy (even fellow eye) or multiple sclerosis (history, clinical examination) * History of other optic neuropathies * History of NAION in the same eye * Active/recurrent ocular inflammation that may prevent retinal imaging