Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587945
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NOMAD
Brief Summary:
Retinal detachment occurs when fluid separates the retina a thin light sensing tissue from its usual attachment at the back of the eye If detached these retinal cells lose their normal blood supply and begin to die which is the primary cause of vision loss in retinal detachment The macula refers to the very centre of the retina with the highest density of retinal cells most responsible for vision Significant vision loss occurs when this part of the retina becomes separated termed a macula-off retinal detachment Typically surgery is required to repair the retinal detachment
Supporting the health of retinal cells at the macula may prolong their survival after detachment and their recovery postoperatively Recent evidence has shown that boosting our nicotinamide adenine dinucleotide NAD levels may improve the health of these cells and prolong their survival if detached Oral Nicotinamide Riboside NR is converted into NAD and while not studied for macula-off retinal detachments has been safely used in a range of other conditions This study is designed to help evaluate the safety and tolerability of NR to help preserve vision in people diagnosed with macula-off retinal detachment
This study drug is given as an oral supplement tablet at the time of retinal detachment diagnosis and daily for 20 weeks thereafter The drug aims to prolong survival of cells in the retina and macula and their recovery after surgery
The long-term goal of this treatment is to reduce loss of vision after retinal detachment The researchers will compare NR to a placebo a look-alike substance that contains no drug to see if NR has a positive effect on photoreceptor survival and quality of vision postoperatively
NR has been approved by the Therapeutic Goods Administration in Australia for many purposes but has not been approved for use in retinal detachment treatment
Supporting the health of retinal cells at the macula may prolong their survival after detachment and their recovery postoperatively Recent evidence has shown that boosting our nicotinamide adenine dinucleotide NAD levels may improve the health of these cells and prolong their survival if detached Oral Nicotinamide Riboside NR is converted into NAD and while not studied for macula-off retinal detachments has been safely used in a range of other conditions This study is designed to help evaluate the safety and tolerability of NR to help preserve vision in people diagnosed with macula-off retinal detachment
This study drug is given as an oral supplement tablet at the time of retinal detachment diagnosis and daily for 20 weeks thereafter The drug aims to prolong survival of cells in the retina and macula and their recovery after surgery
The long-term goal of this treatment is to reduce loss of vision after retinal detachment The researchers will compare NR to a placebo a look-alike substance that contains no drug to see if NR has a positive effect on photoreceptor survival and quality of vision postoperatively
NR has been approved by the Therapeutic Goods Administration in Australia for many purposes but has not been approved for use in retinal detachment treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None