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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06662162




Registration number
NCT06662162
Ethics application status
Date submitted
25/10/2024
Date registered
28/10/2024

Titles & IDs
Public title
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration
Scientific title
Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration (i-SIGHT2): a Multicentre, Randomised, Sham-controlled, Double-masked, Clinical Device Trial.
Secondary ID [1] 0 0
ILS-AMD-202
Universal Trial Number (UTN)
Trial acronym
i-SIGHT2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration 0 0
Age-related Macular Degeneration (ARMD) 0 0
Intermediate AMD 0 0
Geographic Atrophy Secondary to Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - i-Lumen AMD

Experimental: Active i-Lumen AMD therapy - Active transpalpebral microcurrent therapy

Sham comparator: Sham i-Lumen AMD therapy - Sham transpalpebral microcurrent therapy


Treatment: Devices: i-Lumen AMD
i-Lumen AMD transpalpebral microcurrent stimulation system
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change BCVA from Baseline
Timepoint [1] 0 0
Month 3
Secondary outcome [1] 0 0
Portion of per-eye Responders
Timepoint [1] 0 0
Month 3
Secondary outcome [2] 0 0
Mean Change BCVA from Baseline
Timepoint [2] 0 0
Month 6

Eligibility
Key inclusion criteria
Key

* Presence of at least one large druse >125 microns in diameter due to AMD.
* BCVA letter score of 35 to 70 letters (inclusive) (Snellen equivalent 6/12 to 6/60 [20/40 to 20/200])

Key
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any implanted electrical device(s) including deep brain stimulator, hearing or visual implants (i.e., cochlear implant, auditory brainstem implant, retinal prostheses), and/or cardiac defibrillator/pacemaker.
* Implanted metallic device within 20 cm of the Treatment electrode (study eye(s)) and/or the grounding electrode (base of the hairline on the back of the neck).
* Uncontrolled diabetes, defined as glycated haemoglobin (HbA1c) >10% (13.3 mmol/L).
* Current tobacco or tobacco-related product use or history within the past 5 years of heavy smoking (defined as, on average, more than half a pack of cigarettes per day).
* Known severe allergy to fluorescein dye.
* Medical diagnosis of severe dry eye defined as requiring either artificial tears more than six (6) times a day or prescription drops (i.e., Restasis, Xiidra, or Cequa).
* History of seizure disorders, chronic migraines and/or cluster headaches.
* History and/or evidence of diabetic retinopathy in either eye as assessed by CF, fundus fluorescein angiography (FA), and OCT, to be confirmed by the Central Reading Centre.
* Other conditions which pre-dispose to chorioretinal atrophy such as inherited retinal dystrophy (i.e., Stargardt's disease, Best's disease, pattern dystrophy, central areolar choroidal dystrophy, etc.).
* History and/or evidence of exudative AMD in the study eye as assessed by CF, FA (or OCT-A ), and OCT, to be confirmed by Central Reading Centre.
* GA involving the foveal centre, as assessed by the Central Reading Centre using AF and OCT.
* History of intravitreal injections for GA (e.g., Syfovre or Izervay).
* Treatment with photobiomodulation (PBM) therapy or short pulse laser within 12 months prior to screening.
* Glaucoma requiring =3 medications and/or drops per day, or history of trabeculectomy.
* History of any kind of intraocular surgery, excluding cataract surgery performed =3 months from Screening.
* History of yttrium aluminium garnet (YAG) laser posterior capsulotomy <1 month from Screening.
* Visually significant cataracts and/or visually significant posterior capsular opacification.
* History of amblyopia.

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
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2029
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Adelaide Eye & Retina Centre - Adelaide
Recruitment hospital [2] 0 0
Cerulea - East Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
- East Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
i-Lumen Scientific AUS PTY LTD
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
i-Lumen Scientific, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Meredith Mundy
Address 0 0
i-Lumen Scientific AUS PTY LTD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Meredith Mundy
Address 0 0
Country 0 0
Phone 0 0
408-440-7049
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06662162