Microcurrent Stimulation for Dry Age-related Macular Degeneration

Not Applicable

Withdrawn

• Conditions: Dry Age-related Macular Degeneration
• Interventions: Device: i-Lumen AMD; Device: i-Lumen AMD Sham

• Registration Number: NCT04511936
• Lead Sponsor: i-Lumen Scientific, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-12
• Study First Posted: 2020-08-13
• Study Start: 2021-03-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08
• Primary Completion: 2022-01-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
i-Lumen AMD Active	i-Lumen AMD	-
i-Lumen AMD Sham	i-Lumen AMD Sham	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.	1 Month

Secondary Outcome Measures

Name	Time	Method
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.	1 Month