i-SIGHT: Microcurrent Stimulation for Dry Age-related Macular Degeneration
Sponsor
i-Lumen Scientific, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04511936
Collaborator
(none)
0
2
23
Study Details
Study Description
Brief Summary
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
Anticipated Study Start Date
:
Mar 1, 2021
Anticipated Primary Completion Date
:
Jan 31, 2022
Anticipated Study Completion Date
:
Jan 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: i-Lumen AMD Active
|
Device: i-Lumen AMD
Microcurrent stimulator
|
| Sham Comparator: i-Lumen AMD Sham
|
Device: i-Lumen AMD Sham
Sham microcurrent stimulator
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint. [1 Month]
Secondary Outcome Measures
- Best-corrected distance visual acuity (CDVA) response rate at 1 month visit. [1 Month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria - Study Eye:
- Dry AMD diagnosis.
Key Exclusion Criteria - Study Eye:
- Wet AMD
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- i-Lumen Scientific, Inc.
Investigators
- Principal Investigator: Timothy Jackson, MD, King's College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
i-Lumen Scientific, Inc.
ClinicalTrials.gov Identifier:
NCT04511936
Other Study ID Numbers:
- ILS-AMD-101
First Posted:
Aug 13, 2020
Last Update Posted:
Apr 8, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by i-Lumen Scientific, Inc.
Additional relevant MeSH terms: