Microcurrent Stimulation in Dry AMD: Data Timeline

MacuMira’s clinical program is grounded in more than two decades of published research on microcurrent stimulation in retinal disease. This timeline begins in 1998 with the first large-scale clinical study, though supporting research on the underlying technology extends further back still.

From that foundation, MacuMira has advanced the science with its own sham-controlled RCT, real-world outcomes data, and an FDA pivotal trial now underway, with further data generation initiatives planned across biomarkers, structural and functional outcomes, and new indications.

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Background: independent, not MacuMira Present: evidence using MacuMira Future: MacuMira’s pipeline

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Background Data

1998O’Clock & Jarding

Present Data

NowRetrospective (CORE)

Future Data

More
to come

Background Data: 1998–2021

Independent, pre-MacuMira science. None of the studies below were conducted, funded, or commissioned by MacuMira. This is the external body of evidence: open-label studies, exploratory sham-controlled RCTs, and mechanistic research from unrelated investigators that established microcurrent stimulation as a credible, reproducible signal in AMD. It’s the foundation MacuMira was built on.

1998

Independent Open Label · FDA

Electrotherapeutic Device/Protocol Design Considerations for Visual Disease Applications

O’Clock & Jarding

A large-scale study of microcurrent stimulation in AMD. 400 participants; 61% improved by 2 or more Snellen lines. Conducted under active FDA oversight, Phase I double-blind design.

FDA reviewed Phase I results and recommended proceeding to Phase II, marking the original regulatory signal for the therapy.

Click to read the full study

2008

Independent Open Label · Japan

Transcutaneous Electrical Retinal Stimulation Therapy for Age-Related Macular Degeneration

Shinoda et al.

Independent replication of transcutaneous retinal MCS in 21 AMD patients in Japan. Safety and efficacy confirmed by a team with no connection to prior investigators or devices.

First international, independent confirmation that helps to rule out investigator or device-specific bias.

Click to read the full study

2013

Independent Exploratory RCT

Transpalpebral Electrotherapy for Dry Age-Related Macular Degeneration (AMD): An Exploratory Trial

Anastassiou et al.

First transpalpebral RCT with a sham arm. Visual acuity improved +4.4 optotypes (p=0.006). Contrast sensitivity improved (p=0.01). n=22.

The sham arm showed zero improvement, which helps to confirm the effect is not simply a placebo response.

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2015

Independent Exploratory RCT

Microcurrent Stimulation in the Treatment of Dry and Wet Macular Degeneration

Chaikin et al.

Dry and wet AMD across two clinical sites. Dry AMD: 52% improved (p=0.012). Wet AMD: 83% improved. n=17.

Suggests the benefit extends across both AMD subtypes and multiple independent clinical sites.

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2020

Independent Mechanistic

Electrical Stimulation Induces Retinal Müller Cell Proliferation and Their Progenitor Cell Potential

Enayati et al.

MCS activates Müller cell proliferation and progenitor potential in retinal tissue, reactivating the retina’s primary endogenous repair pathway, which is progressively lost in AMD.

Offers early cellular-level evidence for how MCS may produce its effect in retinal tissue.

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2021

Independent Mechanistic · In Tissue

Vitreous Composition Modification After Transpalpebral Electrical Stimulation of the Eye: Biochemical Analysis

Colombo et al.

MCS measurably reduced IL-6, IL-8, and lysophosphatidylcholine in human vitreous, the exact inflammatory biomarkers elevated in AMD. Measured directly in vitreous pre-vitrectomy.

In-tissue evidence of anti-inflammatory action in the specific biomarkers that drive AMD progression.

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2021

Independent Systematic Review

Effectiveness of Microcurrent Stimulation in Preserving Retinal Function of Blind Leading Retinal Degeneration and Optic Neuropathy: A Systematic Review

Liu et al.

Systematic review across 6 independent models of retinal degeneration and optic neuropathy. Consistent neuroprotective and functional preservation effects confirmed regardless of disease type or stimulation protocol.

Meta-analytic evidence that helps confirm the MCS signal is consistent across independent research groups, models, and conditions.

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Present Data: Evidence Using MacuMira

Clinical evidence using the MacuMira device begins here. This includes studies conducted directly by MacuMira, such as the sham-controlled RCT and the FDA pivotal trial, real-world outcomes data from MacuMira’s clinical network, and independent research conducted by outside investigators using MacuMira’s device. All of it builds directly on the background science above.

2023

MacuMira Sham-Controlled RCT

Evaluation of Visual Acuity in Dry AMD Patients After Microcurrent Electrical Stimulation

Parkinson et al.

The largest and most rigorous MCS trial to date. MacuMira’s own sham-controlled RCT (n=62) delivered statistically significant gains on two independent primary outcome measures. Zero adverse events.

+7.7 ETDRS letters, between-group, Week 4 (p<0.001)

+10.4 ETDRS letters, between-group, ~Week 30

Functional gains were confirmed on both BCVA and contrast sensitivity, two independent measures, in the most rigorous study design available to date.

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2026

MacuMira Patients Independent Study

Early Visual Acuity and Contrast Sensitivity Improvements Following Microcurrent Stimulation (MCS) in Dry AMD

Esomchukwu & Shoham-Hazon

Poster at the Canadian Ophthalmological Society (COS) 2026 Annual Meeting by independent investigators from Dalhousie University. Single-center retrospective chart review of 46 eyes from 28 dry AMD patients (mean age 82.7 ± 7.5) treated with MCS, stratified by baseline visual acuity and assessed with ETDRS best-corrected visual acuity and Pelli-Robson contrast sensitivity before and after the four-session loading phase.

Low VA group

+4.2 letters

p=0.055 · 27% gained ≥10 letters

Moderate VA group

+5.0 letters

p=0.013 · 33% gained ≥10 letters

High VA group

+2.7 letters

p=0.008 · 17% gained ≥10 letters

Independent, real-world support suggesting MacuMira’s clinical effect appears quickly (within 10 days of the loading phase), with even high-baseline-acuity eyes seeing clinically meaningful contrast sensitivity gains that reinforce the RCT findings in a real-world patient population.

Click to view the full poster

Now
MacuMira DataReal-World Evidence · CORE StudyReal-World Treatment Outcomes in Dry AMD: A Retrospective Analysis
Centre for Ocular Research & Education (CORE)
Retrospective study by CORE analyzing 251 dry AMD patients across MacuMira’s Canadian clinical network, spanning MacuMira treatments over 2.5 years. The largest real-world MCS outcomes dataset assembled to date. Results expected August 2026.
A real-world complement to the RCT, helping to show the effect holds at scale across diverse clinical settings.

Now
MacuMiraFDA Pivotal StudyFDA Pivotal Study (MMSYS-I)
Multicenter, Randomized, Sham-Controlled Trial
Prospective, multicenter, randomized, double-masked, sham-controlled superiority trial. 104-week duration with primary endpoint at Week 54. Patient enrollment is anticipated to begin by the end of this year.
Primary endpoint: change in BCVA (ETDRS) from baseline to Week 54.

Now
MacuMiraBiomarker StudyTissue Oximetry (StO₂) Study
Measuring retinal oxygen saturation change before and after MCS.

Now
MacuMiraFunctional StudyMicroperimetry Study
Spatially-resolved central field sensitivity mapping, capturing regional treatment effects that a single ETDRS score cannot reveal.

Future Data: MacuMira’s Research Pipeline

These are studies MacuMira is initiating or directly partnering on to extend the evidence base beyond visual acuity, into biomarkers, structure, function, and new indications.

2026+

MacuMira Biomarker Study

Flavoprotein Fluorescence Study

MacuMira Research Pipeline

Assessing mitochondrial redox state via flavoprotein autofluorescence, a direct cellular-level measure of the bioenergetic shift hypothesized to underlie clinical gains.

2026+

MacuMira Structural Study

Ellipsoid Zone Study

MacuMira Research Pipeline

Evaluating ellipsoid zone integrity on OCT, a sensitive structural marker of photoreceptor health.

2026+

MacuMira Functional Study

Dark Adaptation / LLD Study

MacuMira Research Pipeline

Dark adaptation is one of the earliest and most sensitive functional markers of AMD, often impaired before BCVA changes appear. This study captures functional recovery in a dimension patients notice daily.

…

More Studies to Come

This list will keep growing. MacuMira is committed to continued investment in data generation, so clinicians have the evidence they need to make fully informed decisions for their patients.