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
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.
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
Parallel
Transcutaneous Electrical Stimulation
DeviceThe active intervention uses transcutaneous electrical stimulation (TES) delivered by the investigational personal-use electric stimulator (LRTPM1). Electrodes are attached to the ocular and periocular area, and the device delivers pulsed electrical stimulation. Participants will apply the assigned device once daily for 30 minutes over a 12-week treatment period.
Sham Transcutaneous Electrical Stimulation
DeviceThe sham device is identical in appearance to the active investigational device but does not provide active electrical stimulation. Participants will apply the assigned sham device once daily for 30 minutes over a 12-week treatment period.
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
Change from baseline in best corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. BCVA will be recorded as an ETDRS letter score. Higher scores indicate better visual acuity.
Change in Contrast Sensitivity
Change from baseline in contrast sensitivity as measured using a contrast sensitivity chart at four spatial frequencies (3, 6, 12, and 18 cycles/degree). Contrast sensitivity is recorded as a level value from 1 to 8, with higher recorded values indicating better ability to perceive contrast differences.
Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence
Change from baseline in the maximum diameter and area of geographic atrophy as assessed by fundus autofluorescence imaging.
Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)
Change from baseline in drusen area and volume as assessed by optical coherence tomography (OCT).
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score
Change from baseline in vision-related quality of life as assessed by the NEI VFQ-25. The total score ranges from 0 to 100, with lower scores indicating better visual function.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) occurring from the first investigational device application through Week 16. TEAEs include, but are not limited to, transient dizziness, drowsiness, skin redness, skin allergy, headache, pain and muscle spasms, ocular symptoms such as transient eye pain, ocular discomfort, and ocular hyperemia, and hypersensitivity reactions around the application site. Safety will be assessed through monitoring of vital signs, physical examinations, ophthalmic examinations, and adverse event reporting throughout the study period.
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This trial is not recruiting at the moment. You can still explore other options:
