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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06587945


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT06587945
Ethics application status
Date submitted
5/09/2024
Date registered
19/09/2024

Titles & IDs
Public title
Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
Scientific title
A Randomised Double-Masked Placebo-Controlled Trial of Nicotinamide Riboside Oral Supplementation in Macula Off Retinal Detachment
Secondary ID [1] 0 0
U1111-1307-8530
Secondary ID [2] 0 0
NOMAD
Universal Trial Number (UTN)
Trial acronym
NOMAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal Detachment 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Nicotinamide Riboside
Other interventions - Placebo
Treatment: Surgery - Vitrectomy and Gas tamponade

Experimental: Nicotinamide Riboside - Oral Nicotinamide Riboside intake from date of presentation: 2g daily for 4 weeks followed by 1g daily for 16 weeks postoperatively

Placebo comparator: Placebo -


Treatment: Other: Nicotinamide Riboside
Oral Nicotinamide Riboside, 2g daily for 4 weeks followed by 1g daily for 16 weeks

Other interventions: Placebo
Matched placebo

Treatment: Surgery: Vitrectomy and Gas tamponade
Standard of care Vitrectomy surgery for retinal reattachment
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best-corrected Visual Acuity
Timepoint [1] 0 0
20 weeks postoperatively
Primary outcome [2] 0 0
Microperimetry
Timepoint [2] 0 0
20 weeks postoperatively
Primary outcome [3] 0 0
Contrast sensitivity
Timepoint [3] 0 0
20 weeks postoperatively
Secondary outcome [1] 0 0
Integrity of the photoreceptor layer on optical coherence tomography
Timepoint [1] 0 0
20 weeks postoperatively

Eligibility
Key inclusion criteria
* Age = 18 years old
* Able to give informed consent and comply with all study visits and procedures.
* Present within 10 days of macula-off retinal detachment (based on patient-reported history of loss of central vision)
* Present to the hospital with a visual acuity of hand motion or better in the study eye
* Have had previous cataract surgery in the study eye
* Have clinical indication for standard retinal reattachment surgery by means of a pars plana vitrectomy and gas tamponade
* In the opinion of the investigator, be able to safely undergo all study procedures.

Key exclusion Criteria:

* Any known significant ocular disease in the study eye (e.g., cornea opacity) which, in the opinion of the investigator, would preclude a visual acuity of at least 6/7.5 (20/25) following successful vitrectomy or limit adequate visibility of the retina.
* Any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops or intravitreal injection.
* History of previous ocular surgery in the study eye other than uncomplicated cataract surgery with posterior chamber intraocular lens and intact posterior capsule or a refractive surgery (surgery must have occurred at least 3 months prior to the baseline visit).
* Participation in other clinical trials or use of any other investigational drugs or devices within 3 months prior to study participation.
* Females who are pregnant or lactating and women of childbearing potential.
* Known retinopathy, known hepatic disease (or history of significant chronic liver disease), or known renal disease. Patients Participants with diabetes and no known retinopathy may be enrolled.
* History of uncontrolled hypertension.
* History of stroke, transient ischemic attack, or major cardiac surgery within 3 months prior to study, or current treatment for systemic infection.
* Any ocular or systemic condition that in the opinion of the investigator could compromise the safety of the patientparticipant, or may interfere with the safety and tolerability assessments or study procedures of the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2027
Actual
Sample size
Target
144
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Eye Research Australia - East Melbourne
Recruitment hospital [2] 0 0
Cerulea - East Melbourne
Recruitment hospital [3] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [4] 0 0
Dr David Fabinyi - Geelong
Recruitment hospital [5] 0 0
Dr David Sousa - Geelong
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3220 - Geelong

Funding & Sponsors
Primary sponsor type
Other
Name
Center for Eye Research Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Sousa, MD PhD FRANZCO
Address 0 0
Centre for Eye Research Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carly Parfett
Address 0 0
Country 0 0
Phone 0 0
+61399590028
Fax 0 0
Email 0 0
cera-rgo@cera.org.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06587945

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 201
The Royal Victorian Eye and Ear Hospital
Recruitment hospital [2] 202
St John of God Hospital, Geelong
Recruitment postcode(s) [1] 202
3002
Recruitment postcode(s) [2] 203
3220
Funding & Sponsors
Funding source category [1] 112
Charities/Societies/Foundations
Name [1] 112
Center for Eye Research Australia Philantropy Funds
Address [1] 112
Level 10/200 Victoria Parade East Melbourne VIC 3002
Country [1] 112
Australia
Funding source category [2] 113
Charities/Societies/Foundations
Name [2] 113
Perpetual's IMPACT Philantropy
Address [2] 113
The Murray R & Rodney A Brownless Charitable Trust The Merrett Endowment Rowe Family Foundation
Country [2] 113
Australia
Primary sponsor
Other
Primary sponsor name
Center for Eye Research Australia Pty Lts
Primary sponsor address
Level 10/200 Victoria Parade
East Melbourne VIC 3002
Primary sponsor country
Australia
Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 82
St Vincent's Hospital Melbourne Human Research Ethics Committee
Address [1] 82
41 Victoria Parade Fitzroy VIC 3065
Country [1] 82
Australia
Date submitted for ethics approval [1] 82
Approval date [1] 82
Ethics approval number [1] 82
 
Public notes

Contacts
Principal investigator
Title 469 0
Dr
Name 469 0
David Sousa
Address 469 0
SJOG Geelong Hospital Level 6, 80 Myers St Fitzroy VIC 3065
Country 469 0
Australia
Phone 469 0
Fax 469 0
Email 469 0
dsousa@cera.org.au
Contact person for public queries
Title 470 0
Dr
Name 470 0
David Sousa
Address 470 0
SJOG Geelong Hospital Level 6, 80 Myers St Fitzroy VIC 3065
Country 470 0
Australia
Phone 470 0
Fax 470 0
Email 470 0
dsousa@cera.org.au
Contact person for scientific queries
Title 471 0
Dr
Name 471 0
David Sousa
Address 471 0
SJOG Geelong Hospital Level 6, 80 Myers St Fitzroy VIC 3065
Country 471 0
Australia
Phone 471 0
Fax 471 0
Email 471 0
dsousa@cera.org.au