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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1307-8530 | Other Identifier | Universal Trial Number, World Health Organisation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotinamide Riboside | Experimental | Oral Nicotinamide Riboside intake from date of presentation: 2g daily for 4 weeks followed by 1g daily for 16 weeks postoperatively |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide Riboside | Dietary Supplement | Oral Nicotinamide Riboside, 2g daily for 4 weeks followed by 1g daily for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected Visual Acuity | 20 weeks postoperatively | |
| Microperimetry | 20 weeks postoperatively | |
| Contrast sensitivity | 20 weeks postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Integrity of the photoreceptor layer on optical coherence tomography | 20 weeks postoperatively |
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Inclusion Criteria:
Key exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carly Parfett | Contact | +61399590028 | cera-rgo@cera.org.au |
| Name | Affiliation | Role |
|---|---|---|
| David Sousa, MD PhD FRANZCO | Center for Eye Research Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Eye Research Australia | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29599478 | Background | Martens CR, Denman BA, Mazzo MR, Armstrong ML, Reisdorph N, McQueen MB, Chonchol M, Seals DR. Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7. | |
| 26488693 | Background |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C018613 | nicotinamide-beta-riboside |
| D014821 | Vitrectomy |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Multi-centre participant- and assessor-masked placebo-controlled randomised superiority trial with two parallel groups.
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| Placebo | Other | Matched placebo |
|
| Vitrectomy and Gas tamponade | Procedure | Standard of care Vitrectomy surgery for retinal reattachment |
|
| Cerulea | Recruiting | East Melbourne | Victoria | 3002 | Australia |
|
| The Royal Victorian Eye and Ear Hospital | Recruiting | East Melbourne | Victoria | 3002 | Australia |
|
| Dr David Fabinyi | Recruiting | Geelong | Victoria | 3220 | Australia |
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| Dr David Sousa | Recruiting | Geelong | Victoria | 3220 | Australia |
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| Chen AC, Martin AJ, Choy B, Fernandez-Penas P, Dalziell RA, McKenzie CA, Scolyer RA, Dhillon HM, Vardy JL, Kricker A, St George G, Chinniah N, Halliday GM, Damian DL. A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention. N Engl J Med. 2015 Oct 22;373(17):1618-26. doi: 10.1056/NEJMoa1506197. |
| 27721479 | Background | Trammell SA, Schmidt MS, Weidemann BJ, Redpath P, Jaksch F, Dellinger RW, Li Z, Abel ED, Migaud ME, Brenner C. Nicotinamide riboside is uniquely and orally bioavailable in mice and humans. Nat Commun. 2016 Oct 10;7:12948. doi: 10.1038/ncomms12948. |
| 23274583 | Background | Bai S, Sheline CT. NAD(+) maintenance attenuates light induced photoreceptor degeneration. Exp Eye Res. 2013 Mar;108:76-83. doi: 10.1016/j.exer.2012.12.007. Epub 2012 Dec 26. |
| 32852543 | Background | Zhang X, Henneman NF, Girardot PE, Sellers JT, Chrenek MA, Li Y, Wang J, Brenner C, Nickerson JM, Boatright JH. Systemic Treatment With Nicotinamide Riboside Is Protective in a Mouse Model of Light-Induced Retinal Degeneration. Invest Ophthalmol Vis Sci. 2020 Aug 3;61(10):47. doi: 10.1167/iovs.61.10.47. |