Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University College, London
With
Wellcome Trust
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
≥ 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
You may not be if
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
