Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial
<p><strong>Background:</strong> Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel.</p> <p><strong>Objective:</strong> To examine the neuroprotective ef...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Journal article |
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SAGE Publications
2017
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| _version_ | 1797101722847412224 |
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| author | McKee, J Cottriall, C Elston, J Epps, S Evangelou, N Gerry, S Kennard, C Kong, Y Koelewyn, A Kueker, W Leite, M Palace, J Craner, M |
| author_facet | McKee, J Cottriall, C Elston, J Epps, S Evangelou, N Gerry, S Kennard, C Kong, Y Koelewyn, A Kueker, W Leite, M Palace, J Craner, M |
| author_sort | McKee, J |
| collection | OXFORD |
| description | <p><strong>Background:</strong> Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel.</p> <p><strong>Objective:</strong> To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON).</p> <p><strong>Methods:</strong> 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial with scanning laser polarimetry (GDx) at 6 month as a primary outcome measure, optical coherence tomography (OCT), visual and electrophysiological secondary outcome measures. Participants aged 1855 years, ≤ 28 days of onset of first episode unilateral ON, were randomised to amiloride (10mg daily for 5 months) or placebo. (clinicaltrials.gov, NCT 01802489)</p> <p><strong>Results:</strong> ITT cohort consisted of 43 patients; 23 placebo, and 20 amiloride. No significant drug related adverse events occurred.<br/>No significant differences were found in GDx (p=0.840). Visual evoked potentials were significantly prolonged in the amiloride group compared to placebo (p=0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer.</p> <p><strong>Conclusion:</strong> Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm but future neuroprotective trials in ON should target the window of opportunity to maximize potential neuroprotective benefit.</p> |
| first_indexed | 2024-03-07T05:55:53Z |
| format | Journal article |
| id | oxford-uuid:ea7989c2-f48f-4477-b3bb-0a9a04754e1c |
| institution | University of Oxford |
| last_indexed | 2024-03-07T05:55:53Z |
| publishDate | 2017 |
| publisher | SAGE Publications |
| record_format | dspace |
| spelling | oxford-uuid:ea7989c2-f48f-4477-b3bb-0a9a04754e1c2022-03-27T11:02:39ZAmiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:ea7989c2-f48f-4477-b3bb-0a9a04754e1cSymplectic Elements at OxfordSAGE Publications2017McKee, JCottriall, CElston, JEpps, SEvangelou, NGerry, SKennard, CKong, YKoelewyn, AKueker, WLeite, MPalace, JCraner, M<p><strong>Background:</strong> Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel.</p> <p><strong>Objective:</strong> To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON).</p> <p><strong>Methods:</strong> 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial with scanning laser polarimetry (GDx) at 6 month as a primary outcome measure, optical coherence tomography (OCT), visual and electrophysiological secondary outcome measures. Participants aged 1855 years, ≤ 28 days of onset of first episode unilateral ON, were randomised to amiloride (10mg daily for 5 months) or placebo. (clinicaltrials.gov, NCT 01802489)</p> <p><strong>Results:</strong> ITT cohort consisted of 43 patients; 23 placebo, and 20 amiloride. No significant drug related adverse events occurred.<br/>No significant differences were found in GDx (p=0.840). Visual evoked potentials were significantly prolonged in the amiloride group compared to placebo (p=0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer.</p> <p><strong>Conclusion:</strong> Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm but future neuroprotective trials in ON should target the window of opportunity to maximize potential neuroprotective benefit.</p> |
| spellingShingle | McKee, J Cottriall, C Elston, J Epps, S Evangelou, N Gerry, S Kennard, C Kong, Y Koelewyn, A Kueker, W Leite, M Palace, J Craner, M Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title | Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title_full | Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title_fullStr | Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title_full_unstemmed | Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title_short | Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
| title_sort | amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial |
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