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Microcurrent Stimulation Therapy for Intermediate to Advanced Nonexudative Age-related Macular Degeneration

ConditionsAge-Related Macular DegenerationAge-related Macular Degeneration (ARMD)Intermediate AMDGeographic Atrophy Secondary to Age-related Macular Degeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
Sponsori-Lumen Scientific AUS PTY LTD

About this trial

The goal of this clinical trial is to characterize the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in patients with intermediate to advanced nonexudative AMD.

Participants will:

* Undergo an initial loading regimen, followed by 7 maintenance over the course of 11 months. * Participants will return monthly through Month 14 (3 months post-last treatment) for evaluation and monitoring.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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])

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • i-Lumen AMD

    Device

    i-Lumen AMD transpalpebral microcurrent stimulation system

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active i-Lumen AMD therapyExperimental treatment 1 intervention
Group B: Sham i-Lumen AMD therapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change BCVA from Baseline

Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.

Time frame
Month 3

Secondary outcomes

1

Portion of per-eye Responders

1\. Difference in proportion of per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) gaining ≥10 letters from Baseline in distance BCVA ETDRS, active vs sham.

Time frame
Month 3
2

Mean Change BCVA from Baseline

Mean change in per-eye (treated study eye \[unilateral\] or treated primary study eye \[bilateral\]) from Baseline in distance BCVA letter score on the ETDRS VA chart, active vs sham.

Time frame
Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

i-Lumen Scientific AUS PTY LTD

Lead sponsor

i-Lumen Scientific, Inc.

Collaborator

Source ClinicalTrials.gov
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