Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorNu Eyne Co., Ltd.

About this trial

The goal of this clinical trial is to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration.

The main questions this study aims to answer are:

* Does the investigational device improve visual function, as assessed by best corrected visual acuity and contrast sensitivity? * What treatment-emergent adverse events occur during the study?

Participants will:

* Be randomized to receive either active stimulation or sham stimulation * Apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period * Visit the study site for eye examinations and safety assessments * Return for a follow-up visit 4 weeks after the end of treatment

Eligibility criteria

Qualifiers

Participants aged 50 years or older

Participants diagnosed with early or intermediate dry age-related macular degeneration

Participants with best corrected visual acuity measured by the ETDRS visual acuity chart of 20/200 or better and 20/30 or worse

Participants who have voluntarily decided to participate in the study and have provided written informed consent.

Disqualifiers

Participants with atrophy involving the foveal center with a diameter of 175 micrometers or greater in at least one eye, as observed by fundus examination or fundus autofluorescence imaging

Participants with exudative age-related macular degeneration in at least one eye, as observed by fundus examination or optical coherence tomography (OCT)

Participants with a history of intraocular injection therapy or macular laser treatment, including focal laser photocoagulation or photodynamic therapy

Participants with retinal or choroidal diseases other than early or intermediate age-related macular degeneration that may affect the study results, including diabetic retinopathy, retinal artery occlusion, retinal vein occlusion, central serous chorioretinopathy, optic neuritis, or uveitis

Trial design

Treatments tested in this trial

  • Transcutaneous Electrical Stimulation
  • Sham Transcutaneous Electrical Stimulation

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators