Microcurrent Stimulation for Dry Age-related Macular Degeneration (i-SIGHT)
April 6, 2021 updated by: i-Lumen Scientific, Inc.
Microcurrent Stimulation Therapy for Dry Age-related Macular Degeneration (i-SIGHT): a Multicenter, Randomized, Double-masked, Clinical Device Trial
Evaluate the safety and efficacy of microcurrent stimulation therapy for patients with dry age-related macular degeneration.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Multi-center, double-masked, randomized trial of microcurrent stimulation for the treatment of patients affected with dry age-related macular degeneration.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria - Study Eye:
- Dry AMD diagnosis.
Key Exclusion Criteria - Study Eye:
- Wet AMD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: i-Lumen AMD Active
|
Microcurrent stimulator
|
|
Sham Comparator: i-Lumen AMD Sham
|
Sham microcurrent stimulator
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean change from baseline in best-corrected distance visual acuity (CDVA) at one month timepoint.
Time Frame: 1 Month
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Best-corrected distance visual acuity (CDVA) response rate at 1 month visit.
Time Frame: 1 Month
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Timothy Jackson, MD, King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
January 31, 2022
Study Completion (Anticipated)
January 31, 2023
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 12, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 6, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILS-AMD-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.