Microcurrent Stimulation for Dry Age-related Macular Degeneration

Dry Age-related Macular Degeneration Clinical Trial

— i-SIGHT  

Official title:

Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04511936
• Other study ID #: ILS-AMD-101
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2021
• Source: i-Lumen Scientific, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.

Description:

Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria - Study Eye:

• Dry AMD diagnosis.

Key Exclusion Criteria - Study Eye:

• Wet AMD

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• i-Lumen AMD
Microcurrent stimulator
• i-Lumen AMD Sham
Sham microcurrent stimulator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
i-Lumen Scientific, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.		1 Month
Secondary	Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.		1 Month