Phase 2 N=82 BIIB033 In Acute Optic Neuritis (AON)
Acute Optic Neuritis
Primary: Change in Full-field Visual Evoked Potential (FF-VEP) Latency at Week 24: Intent-to-treat (ITT) Population — 20.83; 17.34 msec — p=0.3337
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=44 A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Glatiramer Acetate (GA) on the Retinal Nerve Fiber Layer (RNFL) and Visual Function in Patients With a First Episode of Acute Optic Neuritis (AON). (Octagon)
Optic Neuritis
Primary: Retinal Nerve Fiber Layer Thickness at Baseline and Month 6 — 128.1; 130.5; 89.5; 88.0 µm
Phase 3 N=46 Ampyra for Optic Neuritis in Multiple Sclerosis
Multiple Sclerosis · Optic Neuritis
Primary: Efficacy of Dalfampridine on Visual Function by Early Diabetic Treatment Retinopathy Study (EDTRS) 5% Contrast Sensitivity Scores — -0.04; -0.06; -0.08; -0.06 LogMAR…
Phase 2 N=71 Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis
Optic Neuritis
Primary: Retinal Ganglion Cell Inner Plexiform Layer Thickness — 36.56; 34.65; 31; 29.42 micron
N/A N=40 Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Non-arteritic Ischemic Optic Neuropathy
Primary: Change From Baseline in Visual Acuity at 9 Month — -0.0574; 0.0535 LogMAR
Phase 2 N=117 Traumatic Optic Neuropathy Treatment Trial (TONTT)
Traumatic Optic Neuropathy
Primary: Number of Participants With Change/Improvement Visual Acuity From the Beseline — 28; 3; 5 Participants
Phase 2 N=22 Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Non-arteritic Ischemic Optic Neuropathy · Optic Nerve Injuries
Primary: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit — 15; 7; 9; 6 EDTRS Letters
Phase 1 N=2 Ranibizumab Therapy for Non-arteritic Ischemic Optic Neuropathy
Nonarteritic Anterior Ischemic Optic Neuropathy
Primary: Change in Visual Acuity — 4; 3 lines change in Snellen chart
N/A N=22 Trial of Alternating Current Stimulation in Optic Neuropathy
Optic Nerve Diseases · Optic Nerve Injuries · Optic Neuropathies
Primary: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors — 24.75; 39.16 percent change
N/A N=21,283 Epidemiology Study of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)
Anterior Ischemic Optic Neuropathy · Ischemic Optic Neuropathy
Primary: Crude Incidence Rate of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) Per 1000 Person-years by Age — 0.01; 0.01; 0.03; 0.12 incidence rate per 1000 person-years
Phase 1 N=10 Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations
Neuromyelitis Optica · Neuromyelitis Optica Spectrum Disorder
Primary: Baseline Expanded Disability Status Score (EDSS) — 3.5 units on a scale
Phase 1 N=6 Ublituximab for Acute Neuromyelitis Optica (NMO) Relapses
Neuromyelitis Optica · Neuromyelitis Optica Spectrum Disorder
Primary: Change in Neurological Disability - Expanded Disability Scale Score — 4.0; 6.5; 6.5; 4.0 EDSS unit score
N/A N=219 Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)
Leber's Hereditary Optic Neuropathy (LHON)
Primary: In Eyes With VA Assessment Made ≤1 Year After Onset of Symptoms: Proportion of Eyes With Clinically Relevant Recovery (CRR) of VA (Measured by Change in ETDRS Letters)…
Phase 2 N=70 Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy
Glaucoma, Open-Angle
Primary: Percentage of Patients With a Visual Field Improvement in the Study Eye — 12.0; 9.5; 4.2 Percentage of Patients
N/A N=44 Novel Portable Diagnostic Device for Automatic Detection of Relative Afferent Pupillary Defect
Multiple Sclerosis · Glaucoma
Primary: Number of Participants With Detected Relative Afferent Pupillary Defect (RAPD) — 44; 37 participants
N/A N=100 Optic Nerve Sheath Diameter (ONSD) With the Raised PCO2 and Internal Jugular Venous Occlusion
Elevated Intracranial Pressure (ICP)
Primary: Changes in ONSD in mm With Changes in ICP in Healthy Volunteers. — 4.2 mm
Phase 2 N=14 An Open Label Study of the Effects of Eculizumab in Neuromyelitis Optica
Neuromyelitis Optica · Devic's Disease
Primary: Median Number of Neuromyelitis Optica (NMO) Attacks Per Year — 3; 0 attacks per year — p=<0.0001
Phase 1 N=10 C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation
Neuromyelitis Optica
Primary: Number of Adverse Safety Events During Hospitalization — 0 adverse safety events
N/A N=55 Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
Dry Eye Syndrome · Keratoconjunctivitis Sicca
Primary: Tear Meniscus Height Captured by Optical Coherence Tomography — 238.4; 634.9 µm
Phase 2 N=16 Neuromyelitis Optica (NMO) & Cetirizine
Neuromyelitis Optica
Primary: Annualized Relapse Rate Before Cetirizine — 0.4; 0.1 relapses per year
N/A N=33 Analysis of the Eye in Patients With Primary Open-Angle Glaucoma and a Visual Field Defect in One Eye
Glaucoma
Primary: Lamina Cribrosa (Boundaries of the Retinal Layers) Measurements — 264.3; 273.3; 276.2 micro-ohms
Phase 2 N=19 Study and Treatment of Visual Dysfunction and Motor Fatigue in Multiple Sclerosis
Multiple Sclerosis · Internuclear Ophthalmoplegia · Fatigue
Primary: Pulse Size Ratio (PSR): Abducting/Adducting Eye Ratio for Saccadic Peak Velocity. — 1.914; 1.937; 1.805; 1.898 ratio — p=0.842672
N/A N=50 Effect of Cervical Collar on the Optic Nerve Sheath Diameter in Minor Head Trauma
Head Trauma
Primary: Sonographic Evaluation of Cervical Collar Effects on the Optic Nerve Sheath Diameter in Head Trauma Patients — 4.71; 5.19; 5.26 Milimeter
Phase 2 N=52 Long-Term Assessment of Remyelinating Therapy
Acute Optic Neuritis
Primary: FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW…
Phase 4 N=35 Peripapillary Blood Flow After Use of Anti-glaucoma Medications: An OCT Angiography Study
Glaucoma; Drugs · Normal Tension Glaucoma · Primary Open-angle Glaucoma
Primary: Changes in Vessel Density in Treatment Groups Assessed by OCT Angiography — -0.51; 2.59; -0.96; 0.96 percent change
N/A N=12 Multimodal Analysis and Electroretinogram in VKH From Acute Onset - Part I
Uveomeningoencephalitic Syndrome · Inflammation · Choroid Disease
Primary: Median Values of ERG Scotopic Parameters at 12-month — 201; 210; 508; 92 microvolts — p=<0.001
N/A N=129 Optical Coherence Tomography Angiography Evaluation of Ocular Changes in Patients With Carotid Artery Stenosis
Carotid Stenosis
Primary: Radical Peripapillary Capillaries Vessel Density — 55.95; 57.24 percentage of vessel
N/A N=23 Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis
Multiple Sclerosis
Primary: Change in the Number of Enhancing Leptomeningeal Foci on 1 Year Follow up Compared to Baseline in MS Patients Treated With Ocrelizumab. — 0.07 number of enhancing foci
Phase 3 N=231 N-MOmentum: A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders
Primary: Time to Adjudication Committee (AC)-Determined Neuromyelitis Optica Spectrum Disorder (NMOSD) Attack During RCP — NA; NA Days — p=<0.0001
Phase 2 N=12 A Study Investigating the Safety, Tolerability, and Efficacy of Elamipretide Topical Ophthalmic Solution for Treatment of Leber's Hereditary Optic Neuropathy
Leber's Hereditary Optic Neuropathy
Primary: Double Masked Period: Incidence of Ocular TEAEs — 3; 8; 1; 3 eyes