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Optic Nerve Diseases clinical trials

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NCT ID: NCT02376881 Active, not recruiting - Clinical trials for Optic Nerve Diseases

Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)

Start date: March 2015
Phase: Phase 3
Study type: Interventional

Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin (EPO) has recently emerged as a drug that may help retinal ganglion cell loss and improve optic nerve function in some acquired types of optic neuropathy including traumatic optic neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer some protection to the optic nerve and retina when they are injured and apoptosis process starts in retinal ganglion cells. The standard treatments of methanol poisoning are reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However, after established optic neuropathy and visual loss there is little chance, if any, for visual recovery and no definitive treatment exist for treatment in these cases. The investigators recently reported the investigators preliminary results on 16 cases with methanol poisoning and found a beneficial effect of systemic erythropoietin in methanol associated optic neuropathy. Now, the investigators aim to investigate the effect of this agent in a clinical trial. The purpose of this study is to determine if EPO could improves optic nerve function and help patients to improve visual recovery after methanol poisoning. Primary outcome measure would be best-corrected visual function and secondary outcome measure is ocular coherence tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this study could be very valuable in formulating an evidence-based management of Methanol Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the practice on management of methanol poisoning . Also it could provide valuable data for neuroprotective effects of erythropoietin specifically in neuroscience and ophthalmology. The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter blinded mono-center pilot trial with two parallel groups and a primary endpoint of best corrected visual acuity during 120 days after enrollment into treatment groups. All patients with methanol poisoning referred to Farabi hospital will be examined and evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of anterior segment and fundus exam with 78 D lens.

NCT ID: NCT02341560 Terminated - Clinical trials for Non Arteritic Anterior Ischemic Optic Neuropathy

Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Start date: February 24, 2016
Phase: Phase 2/Phase 3
Study type: Interventional

This study will determine the effect of QPI-1007 on visual function in subjects with recent-onset NAION and assess the safety and tolerability of intravitreal injections of QPI-1007 in this population. This study will also evaluate the structural changes in the retina following administration of QPI-1007.

NCT ID: NCT02329288 Not yet recruiting - Clinical trials for Optic Neuropathy, Ischemic

Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

Start date: May 2015
Phase: Phase 3
Study type: Interventional

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it. Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.

NCT ID: NCT02300753 No longer available - Clinical trials for Leber's Hereditary Optic Neuropathy

Emergency Administration of EPI-743 to a Single Patient With Leber's Hereditary Optic Neuropathy [LHON]

Start date: n/a
Phase: N/A
Study type: Expanded Access

Expanded access Protocol to treat LHON subjects with EPI743

NCT ID: NCT02176733 Recruiting - Clinical trials for Leber Hereditary Optic Neuropathy

Trial of Cyclosporine in the Acute Phase of Leber Hereditary Optic Neuropathy

CICLO-NOHL
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The Leber Hereditary Optic Neuropathy is a genetic disorder caused by maternal transmission of mitochondrial DesoxiroboNucleid Acid mutations. It is manifested by a rapidly progressive blindness, profound, due to atrophic optic nerve. The visual loss is primarily unilateral bilateralisation taking place in the vast majority of cases in weeks or months. The neuro-cardio-protective properties of cyclosporine (and its analogs specifically targeting the anti-apoptotic mechanisms) are particularly promising. The investigators hypothesis is that cyclosporine may limit apoptosis during the acute phase of the disease process and would limit the loss of visual acuity and improve the visual prognosis of these patients.

NCT ID: NCT02161380 Active, not recruiting - Clinical trials for Leber's Hereditary Optic Neuropathy

Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy

LHON
Start date: July 14, 2014
Phase: Phase 1
Study type: Interventional

Hypotheses: The primary hypothesis being tested is that there will be no toxicity resulting in loss of vision to no light perception in injected eyes.

NCT ID: NCT02064569 Completed - Clinical trials for Leber Hereditary Optic Neuropathy

Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients

Start date: February 13, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.

NCT ID: NCT02045212 Completed - Clinical trials for Non-arteritic Ischemic Optic Neuropathy

Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Start date: February 2014
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT02019927 Completed - Trauma Clinical Trials

Electric Stimulation of the Eye to Improve Vision After Trauma

TES
Start date: July 2013
Phase: N/A
Study type: Interventional

Transcorneal Electrical Stimulation (TES) using the "OkuStim®" device delivers electrical impulses to damaged and/or diseased photoreceptor cells. This electric stimulation of the retina may help to preserve visual acuity and/or the visual field.

NCT ID: NCT01975324 Completed - Clinical trials for Non Arteritic Ischemic Optic Neuropathy

A New Medicine to Treat Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Ampyra
Start date: July 2013
Phase: Phase 4
Study type: Interventional

Determine whether dalfampridine (Ampyra) can improve visual function in patients who have had nonarteritic ischemic optic neuropathy (NAION) with stable visual impairment.