NCT05259371

Study of Application of Transcutaneous Pulsed Electrical Stimulation Around Eye in Age-related Macular Degeneration

A 16-Week, Multi-Center, Open-Label, Exploratory Study to Evaluate the Safety and Efficacy of the Application of Pulse Electrical Stimulation Around the Eye in Early to Moderate Dry Age-Related Macular Degeneration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Nu Eyne Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety and efficacy of applying pulse electrical stimulation around eyes of age-related macular patients.

Detailed description

Duration of study period(per participant): Screening period(0-4weeks), Intervention period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2 can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(Baseline).

Conditions

• Early to Moderate Dry Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Transcutaneous Pulsed Electrical Stimulation (Device: Nu Eyne M02)	Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.

Timeline

• Start date: 2022-10-05
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-02-28
• Last updated: 2023-09-11

Locations

3 sites across 1 country: South Korea