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Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT) (i-SIGHT)

Primary Purpose

Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
i-Lumen(TM) AMD
i-Lumen(TM) AMD Sham
Sponsored by
i-Lumen Scientific, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-Related Macular Degeneration focused on measuring AMD, Dry AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Age ≥50 years.
  • Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD
  • Best-corrected distance visual acuity 20/63 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye

Key Exclusion Criteria:

  • History and/or evidence of exudative age-related macular degeneration in either eye
  • History and/or evidence of diabetic retinopathy in either eye
  • Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)
  • Geographic atrophy in the study eye
  • Central chorioretinal atrophy in the study eye
  • Glaucoma in the study eye

Sites / Locations

  • Associated Retina ConsultantsRecruiting
  • Bay Area Retina AssociatesRecruiting
  • University Retina and Macula Associates, PCRecruiting
  • Cumberland Valley Retina Consultants
  • Erie Retina Research, LLCRecruiting
  • Charles Retina InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

i-Lumen AMD Active

i-Lumen AMD Sham

Arm Description

Active transpalpebral microcurrent stimulation therapy

Sham transpalpebral microcurrent stimulation therapy

Outcomes

Primary Outcome Measures

Adverse Device Effects
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study

Secondary Outcome Measures

Full Information

First Posted
June 29, 2022
Last Updated
May 9, 2023
Sponsor
i-Lumen Scientific, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05447650
Brief Title
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
Acronym
i-SIGHT
Official Title
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
i-Lumen Scientific, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).
Detailed Description
The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant. Up to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Dry Age-related Macular Degeneration, Nonexudative Age-related Macular Degeneration
Keywords
AMD, Dry AMD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
i-Lumen AMD Active
Arm Type
Experimental
Arm Description
Active transpalpebral microcurrent stimulation therapy
Arm Title
i-Lumen AMD Sham
Arm Type
Sham Comparator
Arm Description
Sham transpalpebral microcurrent stimulation therapy
Intervention Type
Device
Intervention Name(s)
i-Lumen(TM) AMD
Intervention Description
Transpalpebral microcrurrent stimulation
Intervention Type
Device
Intervention Name(s)
i-Lumen(TM) AMD Sham
Intervention Description
Transpalpebral sham stimulation
Primary Outcome Measure Information:
Title
Adverse Device Effects
Description
Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study
Time Frame
Through study completion, Month 12 timepoint
Other Pre-specified Outcome Measures:
Title
Mean change best corrected distance visual acuity
Description
Mean change from baseline of best corrected distance visual acuity (CDVA) letter score
Time Frame
Through Month 12 timepoint

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Age ≥50 years. Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye Key Exclusion Criteria: History and/or evidence of exudative age-related macular degeneration in either eye History and/or evidence of diabetic retinopathy in either eye Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day) Central chorioretinal atrophy in the study eye Glaucoma in the study eye
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meredith Mundy
Phone
408-440-7049
Email
clinical@i-lumen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith Mundy
Organizational Affiliation
i-Lumen Scientific, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Associated Retina Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah Brookins
Phone
602-242-4928
Email
hannah.brookins@doctrials.com
First Name & Middle Initial & Last Name & Degree
Gabrielle Santor
Phone
602-242-492
Email
gabrielle.santor@doctrials.com
First Name & Middle Initial & Last Name & Degree
Benjamin Bakall, MD
Facility Name
Bay Area Retina Associates
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Monslave
Phone
925-945-6800
Email
lmonsalve@bayarearetina.com
First Name & Middle Initial & Last Name & Degree
Caesar Luo, MD
Facility Name
University Retina and Macula Associates, PC
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maggie Barcewicz
Phone
708-765-4110
Email
maggieb@uretina.com
First Name & Middle Initial & Last Name & Degree
Veeral Sheth, MD
Facility Name
Cumberland Valley Retina Consultants
City
Chambersburg
State/Province
Pennsylvania
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Erie Retina Research, LLC
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoraida Santiago
Phone
814-456-4241
Ext
5401
Email
Zsantiago@erieretinaresearch.com
First Name & Middle Initial & Last Name & Degree
David Almeida, MD, PHD
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendall Beasley
Phone
901-767-4499
Email
kbeasley@charlesretina.com
First Name & Middle Initial & Last Name & Degree
Molly Scott
Phone
(901) 767-4499
Email
mscott@charlesretina.com
First Name & Middle Initial & Last Name & Degree
Stephen Huddleston, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)

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