The FDA has approved an investigational device exemption (IDE) for i-Lumen Scientific, Inc. to expand and initiate enrollment in its global clinical study evaluating a non-invasive bioelectric stimulation therapy for the treatment of intermediate to advanced dry age-related macular degeneration (AMD).
Before we talk about this IDE, refresh me on the company.
Headquartered in Bloomington, Minnesota, i-Lumen Scientific is a retinal biotech company focused on addressing the underlying pathology of dry AMD.
How: Via an investigational device, software, and therapy regimen based on its proprietary technology (reportedly patented in the U.S., Australia, Canada, and the European Union).
Tell me about that tech.
Intended for in-office ophthalmic therapy, the i-Lumen system delivers a proprietary pulsed microcurrent (bioelectric) stimulation to the retina via the i-Lumen AMD device.
Explain this more.
The i-Lumen AMD device carries out this bioelectric stimulation externally—and without implants—via electrodes placed on the eyelid and neck to direct the current to the retina.
- To note: Within this device is proprietary software with preset treatment algorithms calibrated to each patient.
The intended result: The impulse therapy restores the normal function of retinal pigment epithelium (RPE) and Müller cells and restarts the neural pathway to treat dry AMD.
- Why target these cells: They’re noted as playing a critically supportive role for the retina’s neural cells (photoreceptors)—which are responsible for processing light and sending visual information to the brain to form images.
And what’s the thought process, exactly?
The i-Lumen system aims to treat retinal dysfunction by re-energizing retinal cell function through electrical signals (instead of standard, current AMD treatments like pharmaceuticals or injections).
Got it. So, is there any clinical data to back this up yet?
Indeed. In fact, the clinical program evaluating i-Lumen’s technology actually kicked off in 2022 with the U.S.-based iSIGHT study (NCT05447650).
This trial: Was designed as a multi-center, randomized, sham-controlled feasibility device trial that evaluated the safety and effectiveness of the iLumen AMD device among 30 dry AMD patients randomized (2:1 active vs sham) over a 12-month period.
- See here for more details on its participant criteria, study setup, and outcome measures.
- To note: Patients underwent a 5-day treatment regimen with the device followed by two maintenance treatment days at months 1 and 2.
The findings: At month 3, over 50% of treated patients reportedly achieved an improvement in best-corrected visual acuity (BCVA) of ≥2 lines of improvement from baseline.
And the i-SIGHT 2 trial is different, right?
Indeed. For starters, it’s a global trial that initially kicked off enrollment last September in Australia and has since enrolled and treated patients in New Zealand and the UK.
- Outside the U.S., this study is reportedly being conducted by i-Lumen’s Australian subsidiary.
As for its purpose: The company is looking to evaluate the safety and efficacy of the i-Lumen AMD device and therapy among patients with intermediate-to-advanced dry AMD.
Tell me about it.
Here’s what we know about this multicenter, randomized, sham-controlled, double-masked, clinical device trial (NCT06662162), as per Clinical Trials:
- The participants: An estimated 120 dry AMD patients (aged 60+)
- See here for criteria.
- The plan: For patients to undergo an initial loading regimen followed by 7 maintenance sessions over an 11-month period.
- They’ll then return monthly through Month 14 (3 months after the last treatment) for evaluation and monitoring.
And what are investigators measuring?
Measured at month 3, the primary outcome measure is the mean change in BCVA from baseline (on the Early Treatment Diabetic Retinopathy Scale [ETDRS] visual acuity [VA] chart, active versus sham)
- As determined by the average change from baseline in distance visual acuity (ETDRS letter score) in the treated eye, comparing active treatment vs. sham.
And the secondary outcome measures include:
- Portion of per-eye responders (treated study eye [unilateral] or treated primary study eye [bilateral])
- Determined by the difference between active and sham groups in the percentage of treated eyes that improved by at least 10 letters on a distance vision (ETDRS) chart
- Measured at month 3
- Determined by the difference between active and sham groups in the percentage of treated eyes that improved by at least 10 letters on a distance vision (ETDRS) chart
- Mean change in BCVA from baseline
- Determined by the average change from baseline in distance visual acuity (ETDRS letter score) in the treated eye, comparing active treatment vs. sham
- Measured at month 6
- Determined by the average change from baseline in distance visual acuity (ETDRS letter score) in the treated eye, comparing active treatment vs. sham
So why expand the trial to the U.S.?
Aside from the results potentially able to support a future regulatory submission to the FDA for commercialization?
Global principal investigator Timothy Jackson, of King’s College Hospital in London, also noted that this enrollment expansion can only further strengthen the study’s “global reach and scientific rigor.”
And the hope, with the study’s eventual results?
The intent is for the study to provide key evidence on and demonstrate a “meaningful change in visual function,” as well as an "acceptable safety profile” for the i-Lumen AMD device in treating advanced dry AMD patients.
So when will the first U.S. patient be treated?
The company is anticipating U.S. enrollment to begin in late April (no word on a specific treatment timeframe).